overview and services....faster, better, smarter. faster, better, smarter is the deining ethos and...
TRANSCRIPT
Overview and services. About us, what we do and the services we offer.
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About us.
What we do.
Arriello has been a leading provider of risk management and compliance services to the Life Sciences sector since 2008.
These include Market Consultancy, Global Regulatory Affairs strategy and implementation, Full and Local Pharmacovigilance solutions, Clinical Drug Safety, and Quality and Compliance auditing and systems.
Our brief is simple:
To make the process from development to market faster, better and smarter.
Headquartered in Ireland, with European operations in Central Europe, our technical team has a combined experience of over 130 years working across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.
We currently operate in 143 countries with the ability to expand this as required.
With our in-house expertise, vendor network, ISO 9001 certification, years of experience and satisfied clients, including global Originators, Biotechs, Generics and CROs, you can be confident in our ability to deliver as a trusted partner.
I would like to remark on your excellent collaboration with ICON; transparent communication style; timely escalation, responsiveness to the ICON team at all times. This project has encountered many challenges and you have been resilient and committed to the project throughout. Your professional conduct has been exemplary and I am truly grateful.
Barry Rice Project Management Director, ICON plc, Ireland
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How our faster, better, smarter approach impacts your bottom line.
Any company can say it can cut costs, reduce times and improve the service delivery experience.
But that’s not what matters. You want the facts. You want to know how and why they can do it faster, better, smarter.
At Arriello, we’ve got the answers you’re looking for.
When you partner with us, you’ll experience exactly how and why we’ve built our company culture around doing everything faster, better, smarter, and how that impacts your bottom line.
Faster...
Thanks to the skills, experience and diversity of our team, we can analyze your requirements and develop and execute strategies to reach your objectives quickly and efficiently.
And of course, faster is often less expensive at the same time.
Whether you need our broader consulting expertise or specific support for a Regulatory Affairs or Pharmacovigilance requirement, we can deliver exactly what you want, and more – faster.
Better...
We know from years of experience and client feedback that a critical part of how we do it better is about clarity and avoiding miscommunication.
This simple yet often overlooked factor can waste time and resources, raise costs and slow projects down unnecessarily.
Working with Arriello is about partnering with individuals who understand the value of clear and open communication, collaboration, and how the human touch can make all the difference in achieving your objectives a better way.
Smarter...
We best define smarter when the collective power of our expertise and skills works to create the greatest long-term value for your organization.
This requires a deep understanding of exactly what is required, and what changes and implications are likely to have impact based on experience and regulatory intelligence.
No matter what your objectives are, we’re committed to developing the smartest path to achieve both your short-term and long-term goals.
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Services.
An experienced global services provider.
We’ve over 130 years of combined experience in Life Sciences support services, working across 143 countries and growing.
However complex or simple your requirements you can be confident in our ability to deliver as a trusted partner.
Consultancy.
Looking for a strategic consulting partner?We combine years of experience in Regulatory Affairs, Pharmacovigilance and more to anticipate problems, identify opportunities, and create a faster, better, smarter strategic solution.
Regulatory Affairs.
All about the how, when and where.If you’ve current or future Regulatory Affairs requirements, find out how our Regulatory experts can advise, plan and deliver a faster, better, smarter strategy and implementation that achieves your objectives.
Full PV Service.
Minimize your risk and stay compliant.We’ve provided PV services since 2008 across the globe and our team has a combined experience of over 75 years. Discover how we can provide a total solution for all your Pharmacovigilance needs.
Global PV Network.
Current or future Local PV requirements?Our global PV vendor network currently spans 128 companies in 92 countries, enabling us to offer a completely tailored Local PV service solution to meet all your requirements.
Clinical Trials.
A wide range of Clinical Trials services.Arriello brings its years of expertise, reputation and faster, better, smarter service ethos to this fast-growing area, meeting the needs and expectations of current and prospective clients.
Quality and Compliance.
Quality doesn’t happen by accident, it’s built in.Ensuring a faster, better, smarter outcome starts with a deep commitment to excellence. See how our quality-driven culture impacts our Regulatory and Pharmacovigilance Quality and Compliance services.
Brexit.
Whatever the final outcome, we can help you.Nobody knows quite what the impacts of Brexit will be, but you can be sure that we have all the support and services you will need to make a smooth transition to the new era of Anglo/EU pharmaceutical requirements.
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Therapeutic areas.
These are the therapeutic areas we currently cover with live client projects.
Gastroenterology.ATC Code A – Alimentary Tract and Metabolism.
Hematology.ATC Code B – Blood and Blood Forming Organs.
Cardiovascular.ATC Code C – Cardiovascular System.
Dermatology.ATC Code D – Dermatologicals.
Endocrinology.ATC Code H – Systemic Hormonal Preparations,Excl Sex Hormones and Insulins.
Infectious Diseases.ATC Code J – Anti-infectives for Systemic Use.
Oncology.ATC Code L – Antineoplastic and Immunomodulating Agents.
Orthopaedics.ATC Code M – Musculo-skeletal System.
Neurology.ATC Code N – Nervous System.
ISO 9001 Certified.
Everything we do is to the highest standard.All our services are backed up through our ISO 9001 Certified Quality Management system, and all our processes and external partners are fully audited and integrated into it.
Whatever we do for you, it will always meet or exceed current compliance regulations.
The how and why of delivering on faster, better, smarter.
Faster, better, smarter is the defining ethos and the performance management and metrics system that drive Arriello’s level of service along the value chain.
We’ve created a performance culture based around being faster, better, smarter, and how that translates to the reality of measurable positive impacts for our clients.
Faster, better, smarter isn’t just a catchphrase, for us it’s a way of life, because we know that our service, anybody’s service, will be measured on these 3 critical metrics.
So part of my role as CEO is to ensure that the faster, better, smarter culture we’ve built internally is understood, and felt, on the bottom line for clients externally.
Alan WhiteCEO
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Where our services start in a typical product life-cycle.
Basic research Clinical research Production/Marketing/Delivery
PRECLINICAL TRIALS
5 years0 10 years 15 years 20 years 25 years 30 years
CLINICAL TRIALS MAINTENANCE
Possible duration of market exclusivity
Phase I Phase II Phase III
Entry of therapeutic competition
Entry of generic
Marketing authorization
Pharmacovigilance
Pricing & reimbursement
Patent expiration
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Where we operate. Great communication. A core part of being faster, better, smarter.
One of Arriello’s great strengths, and an area where we receive regular praise and positive feedback from clients, is our communication skills.
We know great communication is critical to any project, large or small, and can make all the difference to a successful relationship. That’s why it’s so important to us and one of the common ways we define and measure what delivering a ‘better’ service is.
Better can be measured in many ways but one area we have identified time and again is communication. We know from our client feedback that this is one area where we are consistently superior to our competitors, and we know it is often a critical factor in managing projects, so making sure we ALWAYS try to make communication better is a primary goal for us.
Anna LukyanovaCOO
North AmericaBahamasBelizeBarbadosCanadaJamaicaMexicoUSA
South AmericaArgentinaArubaBoliviaBrazilChileColombiaCosta RicaCuraçaoDominican Rep.EcuadorEl SalvadorGuatemalaHondurasNicaraguaPanamaParaguayPeruPuerto RicoTrinidad & TobagoUruguayVenezuela
Europe/RussiaAlbaniaAustriaBelarusBelgiumBosnia HerzegovinaBulgariaCroatiaCyprusCzech Rep.DenmarkEstoniaFinland FranceGermanyGeorgiaGreeceHungaryIcelandIrelandItalyKosovoLatviaLiechtensteinLithuaniaLuxembourgMacedoniaMaltaMoldovaMontenegroNetherlandsNorwayPolandPortugalRomania
Russian Fed.SerbiaSlovakiaSloveniaSpainSwedenSwitzerlandUnited KingdomUkraine
AfricaAlgeriaBotswanaBurkina FasoCameroonCongoEgyptEthiopiaGabonGhanaGuineaKenyaLibyaMadagaskarMalawiMaliMauritaniaMauritiusMoroccoMozambiqueNamibiaNigeriaRwandaSenegalSouth Africa
SudanSwazilandTanzaniaTogoTunisiaUgandaZimbabwe
AsiaAfghanistanArmeniaAzerbajanBahrainBrunei DarussalamChinaHong KongIndiaIranIraqIsraelJapanJordanKazakhstanKuwaitKyrgyzstanLebanonMacaoMalaysiaMongoliaOmanPakistanPalestinePhilippinesQatar
Saudi ArabiaSingaporeSouth KoreaSyriaTaiwanTajikistanThailandTurkeyTurkmenistanUAEUzbekistanVietnamYemen
Oceania/PacificAustraliaNew Zealand
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Consultancy.
Strategic Life Sciences Consulting.
There’s a reason that strategic consulting is essential to the long-term success of your products. The sooner you engage us as a strategic partner, the sooner we can plan and deliver on your requirements, faster, better, smarter.
Synergy from collective expertise.
Success is about analyzing your long-term goals and knowing whether it’s more advantageous to choose one procedure or route over another. It’s about pinpointing which activities are best conducted with which vendors, and which should be in-house. It’s about having the in-depth knowledge of Regulatory Affairs, Pharmacovigilance, and Quality Management, and using that knowledge to provide strategic guidance that achieves your goals faster, better, smarter.
Health Authority Briefing Packs.
Health Authority Briefing documents are an essential tool to support you with your interactions with health authorities such as pre-submission meetings, requests for scientific advice and protocol assistance.
These interactions can shape the clinical development of a product and as such are clearly of great importance to companies. A well-written and presented briefing document may be crucial, or at the very least, can smooth the path to the desired outcome.
With our considerable regulatory background, we can prepare a briefing document that is readable, clear and has the maximum impact. It will give the best picture of what your product is, its key benefits and why it is a necessary addition to improves people’s lives.
Scientific advice and Health Agency meetings.
A scientific advice meeting is your chance to move your strategic position forward.
Our experts have a wealth of experience preparing and attending such meetings on behalf of our clients.
OTC Switching.
We can devise and deliver a trustworthy feasibility study for Over-The-Counter Switching to assist you in planning for your target markets.
We conduct a rigorous review of the likelihood of a possible switch of individual molecules, both from a clinical and a regulatory perspective, in various therapeutic areas.
We are also able to support you with other OTC support activities, such as Health Agency meetings and OTC Marketing Authorisation Applications (MAA).
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Life Sciences Consulting Informed with Regulatory Intelligence.
The long-term viability of your product can rise or fall on regulatory developments. Staying abreast of changing requirements is critical for a strategy that’s relevant for today, not six months ago.
At Arriello, Regulatory Intelligence profoundly impacts our life science consulting services.
We’re constantly gathering new regulatory data thanks to our global network of vendors and our in-house capabilities.
We consistently monitor the EMA and HMA’s websites, and our local vendors keep a constant watch on new developments from their respective National Authorities and official sources.
The result?Our Life Sciences Consulting service provides solutions that take account of what’s needed now, what’s on the horizon, and how to keep potential risks to a minimum.
Our 5 step consulting process.
Listen.
Providing Life Sciences Consulting that meets your objectives starts with listening very carefully to your current and future objectives. The correct assessment at this stage is critical to delivering faster, better, smarter results for your organization.
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Review.
After thorough analysis, we’ll work with you to explore and discuss the results and what they mean in relation to your objectives. Again, this is a critical step because getting this right is absolutely crucial to developing our solution.
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Implement.
Once we’ve developed and agreed on the best strategic plan for your needs, we leverage our in-house capabilities, our external experts and our global vendor network to deliver on the execution.
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Analyse.
Once we’ve gathered all the relevant information our in-house experts can analyze your situation. Our team’s expertise in Regulatory Affairs and Pharmacovigilance draws upon 130 years of high level experience working across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.
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Propose.
Having shared and reviewed our analysis with you we’ll propose a solution to meet your requirements, a solution built around our faster, better, smarter ethos.
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Clinical Trials.
Arriello’s Clinical Trials services can provide a faster, better, smarter solution to your setup, documentation, reporting, submission and ongoing trial management needs.
The outsourcing of a wide range of Clinical Drug Safety activities and guidance is now a widely accepted, approved and in-demand practice. To bring our years of expertise, reputation and faster, better, smarter service ethos to this fast-growing area, Arriello has created a significant investment and development program in Clinical Trials services to meet the needs and expectations of current and prospective clients.
That services program has now started, initially offering drug safety services to sponsors and CROs that run Clinical Trials.
Establishment and maintenance of sponsor drug safety projects.
At the start of your trial, we can provide a range of setup services to make the whole process faster, better, smarter.A correctly set up project can save you time, money and ensure that all the phases of the trial are robust and efficient.
EV Responsible Person.We can provide the EV Responsible Person for SUSAR reporting to the EMA’s EudraVigilance system.
24/7 drug safety contact point.We can provide the contact point for the reception of SAE/SUSARs from the clinical center/investigator.
Creation of reporting instructions for clinical centers.We can draft all SAE/SUSARs reporting instructions for clinical centers and the sponsor or sponsor representative.
Drug safety and reporting training.We can develop all your training materials for your investigator and clinical staff.
Clinical Trial documentation review.We can provide a full review service for all your protocols, contracts, final reports etc.
Safety management reporting plans – preparation and review.We can draft your drug safety plan to manage all your trial drug safety information.
EudraVigilance Clinical Trial Module registration.We can provide a full registration service with the EudraVigilance Clinical Trial Module.
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Case management.
We work alongside the assessments from your Clinical Trial Principal Investigator, and together with our own assessments, process all documentation and safety database entry. We also handle all authority submissions and ethic committee communications on your behalf.
SAE/SUSAR processing.We can provide a full reporting and expedited reporting service for all your SAE and SUSAR reports.
MedDRA coding.We can provide a complete MeDRA coding service for the submission of case reports.
Global Safety Database management.We can provide a complete Safety Database management service including its establishment, ongoing maintenance and all reconciliation with the Clinical Database.
Aggregate/annual safety reports.
Whatever your safety reporting needs throughout the duration of your trials period, we can handle it, faster, better, smarter.
DSUR processing.We can provide a full DSUR writing service.
Other services.
Submissions and documentation.We can provide a full documentation Submission service to all Local Authorities and Ethic Committees.
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The Clinical Trials timeline.
Arriello offers Clinical Trials services in the areas marked in yellow.
CTD Module – Clinical Safety Publishing
Clinical Study ReportPublishing
Regulatory reporting – SUSARS – NCA/EC/Investigators
Signal DetectionRegulatory Application (Review)
Protocols
CRF define(Case Report Form)
IB #1
AE (Adverse Event) reporting from trial site – Case processing/data management
Signal Detection Signal Detection
NCA/EC NCA/EC NCA/EC NCA/ECSafety Management Plan
Safety Analysis Plan
Trial PeriodTrial Set up 3–6 months
6 months LL DSUR #1Publishing
DSMB meeting
6 months LL DSUR #2Publishing
1 Year IDBD
SMT (meeting periodas defined in the Safety Management Plan)
IB #2Update
SMT meeting IB #3Update
Development RMPMore information is knownCore RMP may be possible
Core RMPAim is to get to this which can then be adapted to EU/Other requirements
Development RMPInitial list of safety concerns as very littleis known about frequency and seriousness
Regulatory IntelligenceRegulatory IntelligenceRegulatory Intelligence
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Expert solutions, delivered.
Every project and client has different needs and requirements, so we focus on listening closely to those needs and expectations, and delivering on them through expert knowledge and our trademark communication skills.
These skills, a core part of our faster, better, smarter ethos, are how we have developed such a strong reputation across all our services.
Arriello can now provide high quality drug safety services to sponsors and CROs that run Clinical Trials.
Our aim is to grow our Clinical Trials services through a significant investment and development program and continue to bring greater value to our clients across the life cycle of their products, right from the trial stage.
Diná CamposDirector of Drug Safety
Arriello offers Clinical Trials services in the areas marked in yellow.
Abbreviations:
IB Investigational Brochure includes Reference Safety Info
NCA National Competent Authority
EC Ethics Committee
LL Line Listing
DSUR Development Safety Update Report (Annual)
RMP Risk Management Plan
SMT Safety Management Team meeting
IDBD International Drug Birthday Date
DSMB Data Safety Monitoring Board (Independant)
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Full PV System.
Minimize your risk and stay compliant. Arriello’s Full Pharmacovigilance System and services.
Take the faster, better, smarter approach and discover how we can provide a total solution to all your Pharmacovigilance needs.
Failing to properly monitor, assess and report safety concerns puts patients as well as your investment in your Marketing Authorization at risk. That’s why it’s essential to have a proven and robust Pharmacovigilance System in place.
Arriello has been a leading supplier of Global and Local Pharmacovigilance services, since 2008. Our team has a combined experience of over 75 years across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.
We are constantly expanding our global coverage and currently operate in 143 countries, with the ability to expand this as required.
Our Full Pharmacovigilance System and services have been developed and refined over several years and is maintained by our in-house European Union Qualified Person Responsible for Pharmacovigilance (EUQPPV) and Deputy QPPV, backed up with the support of a range of medical specialists.
Whatever your pharmacovigilance needs, our experts can advise, implement and continue to minimize your risks and keep you fully compliant.
Thank you very much to you all involved recently providing the necessary additional audit documents requested by the authorities. Your support was instrumental in successfully finalizing a process that started back in February.
Dr. Michael Lange Managing Director, Sintetica GmbH, Germany
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Core services.
Monitoring of authorities’ websites.We constantly monitor the EMA (European Medicines Agency) and HMA’s websites for global PV regulatory intelligence applicable for the whole EU and use our findings to advise and update your procedures.
EudraVigilance maintenance.Your EudraVigilance profiles for production and testing are registered and maintained by our experienced EU QPPV (Responsible Person) and Deputy EU QPPV (Trusted Deputy). We make sure your medicinal products are entered and updated in the Article 57 database accurately and on time.
PV System setup and maintenance.We are fully responsible for the creation and update of your Pharmacovigilance System Master File (PSMF).
Comprehensive Management of ICSRs.
Managing your individual case safety reports (ICSR) accurately and efficiently is critical to an effective PV system and Arriello provides full support for each step of the ICSR handling process.
From confirmation and translations to data entry and archival, we’ll manage your safety data and meet all your ICSR requirements.
Our capabilities include MedDRA coding, case assessment, and electronic reporting through EudraVigilance.
Aggregate Safety Reports.
We can handle all your Aggregate Safety Reporting obligations throughout the life-cycle of your product with the creation of Development Safety Update Reports (DSUR) and Periodic Safety Update Reports (PSUR).
From compiling your DSUR information to preparing your PSUR for the European Medicines Agency (EMA), we have the knowledge and expertise you need to stay compliant with requirements.
Choosing the right service and people is critical.
Your choice of Pharmacovigilance provider can have profound impacts on the success of your products in the marketplace through their life cycles.
Ensuring compliance and safety, whilst being able to manage risk and plan around change, requires experience and depth of knowledge in order to provide an excellent Pharmacovigilance service for clients.
To be effective, you have to be supported by the right company infrastructure, with in depth knowledge and a great Quality Management System. And that’s exactly what we have built at Arriello, because these are our foundations of an efficient PV System and an excellent service.
Peter KohutSenior Pharmacovigilance Manager | EU QPPV
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Global Literature Monitoring.
Global Literature Monitoring is a key part of a full Good Vigilance Practice (GVP) based Pharmacovigilance system and at Arriello, we screen using Embase with Medline database.
Using broad and narrow literature queries, we search for ICSRs, published studies and information relevant for the safety of your products. We make sure we’ve fully assessed any available information that may impact on patient safety or require further investigation.
Risk Management.
An effective Risk Management System and the development and update of Risk Management Plans, mandatory in the EU, are a critical part of Pharmacovigilance and patient safety.
If you don’t effectively monitor for important identified and potential risks or missing information your Marketing Authorization or Application is itself at risk. Arriello’s in-house risk management expertise can identify new safety concerns and propose appropriate risk minimization measures, keeping you compliant and improving patient safety.
Pharmacovigilance Signal Management.
Rely on Arriello for signal management, and gain peace of mind knowing our experts have the in-depth knowledge you need to stay compliant. From keeping tabs on adverse events in EudraVigilance to helping your organization follow Good Pharmacovigilance Practices (GVP), our team members will help you follow the right regulatory guidelines.
Pharmacovigilance training.
In addition to our in-house Pharmacovigilance services, we can also provide Pharmacovigilance training for your specific project or as a standalone service.
Understanding your portfolio and expectations is the key.
To build an optimal PV system solution for our clients, we use expert knowledge of the current and likely legislation, experience, and of course a deep understanding of their portfolio and expectations.
That focused client/compliance/safety approach, together with our faster, better, smarter ethos, enables us to build an optimal PV solution.
Every client has a different portfolio, with their specific needs and expectations and at Arriello we make sure we really understand what our client’s needs are, currently and with a view to the future, because without that deep client insight you cannot build an efficient, tailored solution or system that matches those requirements to regulation, compliance and patient safety.
Miroslava MatikovaEU QPPV | Pharmacovigilance Project Manager
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Thanks Miroslava, you have certainly worked hard over the years and have given Ascot a first class service.
Phillip Gent Quality Assurance Manager, Ascot Laboratories Limited, UK EU QPPV | Pharmacovigilance Project Manager
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Global PV Network.
Risk management and compliance in 143 countries around the world.
A poor translation can lead to a misunderstood critical report. An article on an adverse reaction buried in a local scientific journal can go undetected. A follow-up on a case isn’t carried out. All these errors can lead to serious repercussions for you, and for patient safety.
It’s an undeniable fact; an ineffective Local PV service can lead to a significant level of risk with non-compliance of regulatory requirements, major or critical inspection findings, and patient safety.
And that’s why the quality and efficiency of the processes and management of your Local PV System is critical.
Arriello has been a leading supplier of Global and Local Pharmacovigilance services, since 2008. Our team has a combined experience of over 75 years across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.
We are constantly expanding our global coverage and currently operate in 143 countries, with the ability to expand this as required.
Our global network of external PV vendors currently spans 128 companies in 92 countries, enabling us to offer a completely tailored Local PV service.
Throughout the project you have approached the ICON-Arriello relationship with a friendly, constructive and collaborative attitude. I personally appreciated your valuable support, professionalism and conscientiousness. In the face of conflicting priorities and multiple customer demands you remained composed and professional.
Donna Hartley Drug Safety Manager, Pharmacovigilance and Safety Services, ICON plc, Ireland
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Arriello’s Global Pharmacovigilance (PV) Network and services.
Take the smarter approach and discover how we can provide a comprehensive Local PV solution through our global vendor network.
Drug Safety Officer.
A major and growing role in Pharmacovigilance is that of the Drug Safety Officer (DSO). This role is often connected/interchangeable with the titles Local Safety Officer (LSO), Local person Responsible for Pharmacovigilance (LRPV) and others which can differ country by country and client by client.The DSO role objective is primarily the same regardless of title; to have a dedicated knowledgeable and efficient technical service at the individual country/territory level.
At Arriello we offer a unique blend of in-house resource and expertise, combined with local in-country staff who fully understand local regulations. This includes but not limited to:Individual Case Safety Reports (ICSR) intake and local level processing, local submissions (aggregate reports, RMPs, ICSRs, etc.), compliance monitoring, the implementation of Local PV requirements in relevant procedures and systems, providing PV/product-specific training, Health Authority inspections and many more! As the role is flexible depending on individual client needs and Local PV regulations, the exact mix of capabilities and requirements varies.
Whatever your Drug Safety Officer requirements, we can propose and deliver a faster, better, smarter solution to meet them.
Local Person Responsible for Pharmacovigilance (LPPV).
Through consultation and our extensive experience and knowledge of Local PV requirements, we know what is required in each market and how that matches your requirements. We can then provide either a Local Qualified Person for Pharmacovigilance service (LQPPV), or a Local Contact Person for Pharmacovigilance service (LCPPV).
We can do this in all your markets through our comprehensive global vendor network which is qualified and audited by our dedicated vendor management department.
How do we operate in 143 countries?
We have a highly trained and knowledgeable network of local specialists that meet our faster, better, smarter standards, and can respond to sometimes frequent changes in local legislation.
And our rigorous auditing program makes sure we deliver for our clients, on time, every time.
Although the PV principles remain the same, every regulatory authority and every company can have a different interpretation of PV requirements and PV legislation.
With the depth of expertise we have at Arriello, and the quality of our extensive global network, we can and do meet all the Local PV requirements of regulators, and our clients, faster, better, smarter.
Zuzana PlánočkováGlobal PV Network and services
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Local Literature Monitoring.
Literature Monitoring specifically at the individual country level is a key part of our local pharmacovigilance system at Arriello. Using broad and narrow search strategies and keywords, we search local medical and scientific journals including published study results, literature reviews, meta-analysis, etc.
We make sure we’ve fully assessed any available information that may have an impact on patient safety, or require further investigation or changes required in specific markets.
Regulatory Intelligence.
Our faster, better, smarter approach extends right down to the requirements from our local vendors. They provide us with regular updates on changes to local regulatory requirements and legislation by monitoring official sources such as their National Competent Authority, Health Ministry websites and others. Then, all this information is double-checked by another vendor to ensure all it is correct.
This depth of research and monitoring, with a double-checking process, means you can be confident that you’re completely compliant in that market. Plus, you’ll gain country-specific insights that could reduce your risk and allow ample forward planning of changes and implementation that can impact your PV System or your product.
Local level Case Management.
We offer complete support in management of ICSRs on local level, including but not limited to.
Safety mailbox management.We can monitor, assess, track, process and forward any correspondence and information received in the local safety mailbox.
Local case submission.We can process all local submissions to the National Competent Authorities according to the country specific requirements (e.g. on format, timelines, route of submission, etc.).
Case follow-up.We ensure that all cases that require additional information after initial review are rigorously followed-up back to their sources.
Safety Reports.
Whatever the specific requirement is for writing and developing safety reports, you can trust Arriello’s pharmacovigilance experts to gather the right data, use the right formats, and follow the right processes to comply with local regulatory requirements.
Pharmacovigilance Translations to/from Local Languages.
Clear communication is critical for maintaining your MA and protecting lives. We provide translations specifically for Life Sciences materials across all therapeutic areas.
From ICSRs to abstracts and articles from local literature screening, translations are available in virtually any language and at any scale.
Our network is based on a mix of certified translators, or local translators that meet a minimum three criteria of medical background, local language plus English knowledge.
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Vendor Vetting and Management.
Our global network of external PV vendors currently spans 128 companies in 92 countries, but that doesn’t mean they aren’t subject to the demands of our faster, better, smarter culture.
When you partner with Arriello you can be sure quality extends right through to our vendors thanks to the robust processes our vendor management department has in place for vetting and management including:
Qualification for selection.Using a balanced scorecard, our department assesses and monitors potential vendors based on predefined criteria.
Reporting.We regularly require our vendors to provide reports on their performance, which are then checked internally by our PV project managers and specialists. We also monitor all reporting timelines are adhered to for compliance too.
Compliance monitoring.To ensure our vendors are fully compliant, we conduct on-site and off-site audits based on the frequency identified in the approach to risk planning or Risk Management Plan.
Risk Minimization activities.
At Arriello, we provide support several risk minimization activities targeted at increasing patient safety close to the source.
These can include documents that may help physicians properly prescribe your drug or patients and doctors to properly use it (e.g. Direct Healthcare Professional Communication (DHPC), educational materials and other communications) – all according to the guidelines and requirements of the national competent authorities in that location.
Designing faster, better, smarter PV systems.
We define a faster, better, smarter Pharmacovigilance solution as meeting our clients’ needs whilst making sure there is no compromise in compliance and safety.
And that approach is also fundamental to ensuring our relationships are built on trust and investment as a long term partnership. This is how we build systems for today, and tomorrow.
Our focus is on understanding the needs and expectations of our clients and providing them an integrated and efficient service. We design solutions that ensure compliance and patient safety to the highest standards applicable.
And of course, this has to match our client’s market strategy – an area where we also offer a full Consulting and Regulatory service.
Diná CamposDirector of Drug Safety
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Regulatory Affairs.
How, when and where.The smarter approach to Pharmaceutical Regulatory Affairs.
The decisions you make about Pharmaceutical Regulatory Affairs can fuel your growth, or create unnecessary obstacles between you and your objectives.
Initially launching your drug in one country can speed up its launch in another, but it might potentially cap your pricing in other countries, or across an entire regulated market!
That means successfully navigating regulatory requirements is more than simply following the rules, it’s about understanding the complexities and implications of different procedures and requirements across international markets, and developing the best strategy for your current and future needs around them.
With over 55 years combined experience, Arriello has the in-house expertise to develop and execute that strategy worldwide across the EU, US, LATAM, MENA, CIS, APAC regions and South Africa.
It doesn’t matter if you’re a US-based biotech looking to reach specific or all markets, or you need guidance for OTC authorization. From preparing and maintaining dossiers to providing translation services, we make sure our clients can achieve their goals faster, better, smarter.
Arriello has highly knowledgeable staff in all countries with a very professional attitude. They are very fast in responding when needed.
Berit Lindholm CEO, Bluefish Pharmaceuticals, Sweden
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Where our Regulatory services start in a typical product life-cycle.
Research Approval Commercialization
Quality Management System – ISO 9001
GCP Inspections
Clinical Development Strategy
Clinical Trial Applications (CTA, ARR)
Formulation Development
In-vitro Dissolution Testing
Submission Strategy
(Centralised, National, DCP or MRP)
Marketing Authorisation Application
eCTD Publishing
Submission in Other Markets
Variation Applications
Product Reclassification
Renewal Submissions
DoMA (Deletion of Marketing)
GMP Inspections GXP Inspections
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Pre-Submission Support.
Set your CTD up for success with expert strategic guidance, and leverage over 55 combined years of experience in Regulatory Affairs. Explore the comprehensive services we provide, including:
Gap analysis.We’ll evaluate your dossier and pinpoint what’s missing, as well as the steps you should take to correct it.
Dossier updates.Your dossier is a living document – keep it updated with the information you need for successful submission.
GxP inspection support.From Good Manufacturing Practice (GMP) inspections to Good Distribution Process (GDP) inspections, we’ll provide the guidance you need for inspection approval.
WDA application support.Rely on Arriello to shorten your WDA application timeline so you quickly reach your target market.
Electronic Common Technical Dossier (eCTD) support.Remain ICH compliant, and tap into our expertise in submitting eCTDs. Our comprehensive support includes Readability and User Testing (RUT), preparing all Module 1 documents, and providing expert overviews as well as artwork and labeling among other activities.
Submission Support.
Submitting an eCTD is no longer an option, it’s a necessity. At Arriello, we’ll publish your eCTD and can convert older NtA or NeeS dossiers quickly and accurately.
To expedite the process, allow us to submit your dossier and follow up with the appropriate agencies until you’ve successfully received your Marketing Authorization (MA) approval.
When you partner with Arriello, we can also act as your:
Applicant or authorized representative.Let us handle all the administrative tasks of your application and communication with Authorities, and take the headache out of securing your MA.
Market Authorization Holder.If you lack a presence in your target market, let our team become an extension of your own organization. We’ll hold your Market Authorization and transfer it to you afterwards.
Post-Submission Support.
Submitting your CTD is only part of reaching your goals and realizing continued success. Arriello’s continued support includes:
National phase management.Gain targeted support for navigating individual countries’ pharmaceutical Regulatory Affairs requirements.
Translation.Let us connect your organization to the linguistic expertise you need to translate your texts into the local languages of your target markets.
Market Authorization Transfer (MAT) support.When it’s time to transfer your MA, we’ll walk you through the process, step by step.
Product whole life-cycle maintenance.Your dossier undergoes constant changes. Rely on Arriello for renewals, extensions, and variations to your CTD.
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With over 55 years combined experience in Regulatory Affairs, we’ve the depth and expertise to help you with any project.
Arriello’s Regulatory Affairs team can provide a range of efficient, expert services from development to lifecycle management.
Whatever your strategy requirements and challenges are, we can help you overcome them, faster, better, smarter.
I’m proud to lead an experienced, passionate and enthusiastic team at Arriello.
We are focussed on providing quick, effective and strategic regulatory solutions for our clients, guiding them through implementation, or acting as their extended regulatory team.
Gabriela MartonRegulatory Affairs Director
I’d like to personally thank you for the high quality of Regulatory support you’ve given us so far, especially Gabi and Maria and your local partners. We’re very satisfied with the service.
Jaya Ramakrishnan General Manager – Regulatory Affairs, Bluefish Pharmaceuticals, India
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Quality & Compliance.
Regulatory and PV compliance starts here.
Implement quality management best practices and systems that keep you compliant and improve all your processes, faster, better, smarter.
Quality doesn’t happen by accident, it’s built in.
Ensuring a faster, better, smarter outcome starts with a deep commitment to excellence.Discover how our quality-driven culture impacts our Regulatory and Pharmacovigilance Quality and Compliance services.
What Quality Management means for you. Experience what it’s like to work with an organization that achieves the right goals, the right way.
Partnering with Arriello means carefully selected employees, trained vendors, and continuously improved processes.
Our mission for your organization.Whatever the size of your organization, our mission remains the same. We’re here to listen to your needs, monitor for the latest developments, and leverage our knowledge to deliver excellence in our Quality and Compliance consulting and services.
ISO 9001 Certification.Helping your organization improve its quality management starts with us. We’re fully ISO 9001 certified and focus all those best practices and knowledge, gained through years of successful audit inspections and approvals, on meeting your requirements.
The rewards of improved Quality Management.With Arriello, you’ll quickly notice the impact of closing gaps in your quality system and processes.
Enter an audit inspection prepared, ensure there’s no question marks over your Marketing Authorization.
Put simply, improving your Quality Management helps you face the future and plan with confidence.
Quality System + PV Audit.
Take your quality system audit to the next level.
With this service, we’ll look at your QMS and your pharmacovigilance system together. Go beyond an evaluation of your organizational processes and discover if your company follows Good Pharmacovigilance Practices (GVP). We’ll examine all your procedures to ensure you’re compliant, and your patients are safe.
Quality System Audit.
Measure your systems and processes against industry best practices.
With a Quality System Audit, we’ll audit your organization’s Quality Management System and processes, and identify the issues that need improvement. And of course, we’ll leverage all the experience we gain from being regularly audited ourselves.
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Full Audit Report.
Whether you choose just an audit of your QMS or to dive deeper to include your Pharmacovigilance System, we summarize our analysis, your gaps and recommendations in a detailed report.
Most importantly, you’ll walk away knowing what steps to take next, and should you wish, you can select any combination of our services below to craft the solution you need.
A culture of quality.
At Arriello, quality management has been embedded into our operating culture as part of our faster, better, smarter approach and is critical to our, and your success.
Our faster, better, smarter approach to all the work we do meant we needed to follow a proven and globally recognized quality standard, and this is why we chose to become fully ISO 9001 certified and embed this into our practices and culture.
We work exceptionally hard to maintain this system and it underpins all the work we deliver clients. It’s a key part of why they love what we do and why we’ve become a trusted partner to them.
Build a Quality Management System.
Let us create a system for you that will keep you compliant, meet your objectives, and mitigate your risks. Whether your QMS has gaps or is entirely absent, we’ll help you establish a fully functioning system to industry best practices.
Hire a Quality Auditor.
The gaps and issues identified through the audit process will generate a series of CAPA’s – Corrective Action/Protective Actions that are required. You can hire one of Arriello’s Quality Auditors to work with you in implementing these CAPA changes to update your system and processes.
Prepare for Your PV Audit Inspection.
A pharmacovigilance audit inspection can be nerve wracking and have widespread consequences if there are problems. We’ll help you understand what’s required, when it’s required, and we’ll train your team and/or provide all the support you need during the audit.
Kamila MekýšováQuality Specialist
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Our digital solutions vision.
Arriello is building a range of interconnected products for the Life Sciences industry that leverage the latest in automation, artificial intelligence and technology.
Through a balanced approach between digital enablement and human expertise, our focus is on creating solutions that are faster, better, smarter with less risk than existing processes, or that create entirely new ways of working.
Our systems and solutions aim to enhance, improve or redefine areas such as individual case safety reporting, medical information, literature screening, medical information, regulatory information and signal detection.
How we intend to get there.
To achieve our vision, we intend to build each product based on the needs and opportunities of both our internal service areas and from client feedback.
Our belief is that we should develop software with life science experts, for life science experts, to make sure what we’re building and why we’re building it, have a solid foundation in real world application.
On top of that our key objective is to make everything we create simple and intuitive through good UI and UX design, so that use is a positive progression from the systems and processes we use today.
In this sense, our trademark communication and transparency approach is replicated in the use of technology to create digital systems that are truly faster, better, smarter ways of working.
Intelligent automated products.Delivering products that embody the Arriello brand.
Faster, better, smarter is Arriello’s defining ethos, so it’s important that our move into creating automated and intelligent products matches that brand expectation.
This approach keeps our products innovative, differentiated and easy to use in the real world scenarios they are designed for.
Creating these new automated and intelligent products requires careful assessment, review and testing of all our ideas and features, coupled with a great user experience, all packaged so that it’s clear these are Arriello systems and solutions. It’s critical that we ensure our brand promise extends into the non-human domain of software, in the same people/client/human way it does currently.
Rob CurtisMarketing Director | Automated Products Director
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IntelliCASE provides a simple, intuitive and easy way to complete a structured case report form on your mobile device. It indicates the fields required for a valid case, allows you to attach photos or other files, save the report as a draft if required and preview/edit it before submission.
Case processing follow ups with urgency levels and required dates are also handled in-system direct to the user dashboard with email acknowledgements for each case/update submission.
Fully validated to GAMP 5 GxP standards and recommendations, IntelliCASE is E2B R3 compliant and can be adapted to E2B R2 systems as required.
Creating a case report, on the move, when you want, just became a whole lot easier.
Enter data by text, or speech, in your language.
But what makes IntelliCASE a unique world’s first in the market is the ability to enter data from your voice, in over 100 languages, alongside keyboard text entry. That makes the entry of more detailed or longer information easier, and the likelihood of better and more detailed data higher. And the system can be programmed to learn and recognize 100 specific product/treatment/condition keywords for each question. Using a clear, intuitive and easy to use interface with voice capabilities frees users up from having to report cases by email and traditional forms, and encourages faster, better, smarter reporting overall, with downstream effort reductions and reduced follow ups. The user interfaces for both the Reporter and Tracker modules can be customized to your language requirements beyond English.
IntelliCASE.
Speech enabled case reporting in your pocket!
IntelliCASE is the world’s first mobile, customizable, ICSR solution that allows you to use speech to text in multiple languages.
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Module 1. Reporter.
The IntelliCASE Reporter module allows users to create, review and report a case via their mobile device from anywhere with internet access. Data can go to the Tracker module or directly to a client Safety Database.
Supported by HTML 5 compliant browsers.
Module 2. Tracker.
The IntelliCASE Tracker module can be used as the case processing tool and/or as a system for reconciliation with an external client Safety Database.
Supported by HTML 5 compliant browsers.
Who is it for?
The initial use scenario and development for IntelliCASE has been Field Representatives, who report cases as part of their Health Care Provider client network, but we expect to develop the system and interfaces to client requirements for direct HCP, Pharmacy or Patient Support Program reporting.
IntelliCASE was built to be customized from an easy to integrate base system to your user scenarios and technical requirements from the ground up. By designing the system around smart essentials for speed and ease of use, it avoids the need for complexity to connect to your existing systems, makes regulatory compliance easier, and focuses on the ability to create a user experience perfectly tailored to your reporting needs.
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Instant translation ability.
The IntelliCASE Tracker module also has some speed related features around translation built in such as:
An instant quick translation using Google Translate into English that allows PV specialists to make an initial quick assessment of a case ahead of any further translation.
A “Send for translation” option can be used to instantly send a case to a certified translator, or to a translation vendor.
IntelliCASE features and benefits.
E2B compliant.Connects to your E2B R3 safety database and can be adapted for E2B R2.
Validated.GAMP 5 GxP validated for auditing and quality management compliance.
In-system follow ups.Urgency levels and dates direct to the user dashboard.
Multi-lingual.Selection of multiple voice input languages.
Customizable.Your language interface/ system/user requirements.
Accessible.Outputs data/audit trails to most common formats, customizable to any others.
AI capable.Developed to use custom insight algorithms with your data.
Easy.Clear, intuitive and easy to use interface.
Portable.When and where you want online.
Voice or text input.It’s your choice.
Fast.Direct transfer to Tracker and client safety DB.
Efficient.Faster, easier input, better data, rapid/reduced follow ups, instant acknowledgements.
Expert design.Developed by PV people, for PV people.
Focused.PV specialists spend more time on thinking and analysis than labor intensive administration = more focus on safety.
From intelligent automation to artificial intelligence.
The IntelliCASE system was built in partnership with Artificial Intelligence specialists Good AI with an expectation that at some point we would be able to extend the use of your case report data if required.
Depending on the amount of data you have, and what you might want to know (or what you didn’t think of until now), we can create a further tailored custom solution using algorithmic and machine learning capabilities that can provide impactful business insights or predictors.
About us.
Arriello has been a leading provider of risk management and compliance services to the Life Sciences sector since 2008.
These include Market Consultancy, Global Regulatory Affairs strategy and implementation, Full and Local Pharmacovigilance solutions, Clinical Drug Safety, and Quality and Compliance auditing and systems.
Our brief is simple; to make the process from development to market faster, better and smarter.
Headquartered in Ireland, with European operations in Central Europe, we provide expert Market Access guidance across the EU, US, LATAM, CIS, MENA, Asia and South Africa.
With our extensive global vendor network, ISO 9001 certification, years of experience and satisfied clients, including Global Originators, Biotechs, Generics and CROs, you can be confident in our ability to deliver.
However complex or simple your requirements, you can rely on us as a trusted partner.
Global Headquarters
Arriello Ireland LimitedNo. 51, Bracken RoadSandyford, Dublin D18 CV48 IrelandPhone: +353 1 293 6755
European Operations
Arriello s.r.o.Olivova 2096/4Prague 1, 110 00Czech RepublicPhone: +420 222 367 765
USA Office
Arriello USA LLCOne Marina Park Drive Suite 1410Boston, MA 02210USAPhone: +1 617 807 7016
Email: [email protected]
linkedin.com/company/arriello_group
www.arriello.com