partnering with clinsearch
TRANSCRIPT
Partnering withClinSearch
2015
Ivelina Georgieva, International Account Manager
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ClinSearch in Brief
• Founded in 1999 by Jerome Seymour, PhD, and Fabrice Ruiz, MS
• Headquarters: Paris
• Current staff count: 60, including medical and scientific advisors, project
managers, monitors, statisticians, data managers, IT specialists, and medical writers
• Annual turnover: 4 million EUR
• Clients include big pharmas and medical device manufacturers, biotechs and public health institutions.
ClinSearch in brief 2015
3ClinSearch & You 2015
• Faster return on investment
• Increased capital gain
• Increased stability
• Heightened confidence in
products
• Gain a committed consultant
YOU
• Accelerated clinical process
• Faster and more efficient path to market
• Successful regulatory submissions
• Receiving reimbursement
• Limit resourceexpenditure
YOUR INVESTMENT
• Expert knowledge
• Develops and implements an effective
clinical strategy
• Proactiveness and entrepreneurship
• Performs all clinical processes in-house with
stringent QA
• Access to international investigation sites, close long-term partnerships
CLINSEARCH
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OUR SERVICE LINES :
Scientific consulting
Projects include: clinical evaluation; study design and statistical methodology, review and editing of client synopses, scientific communication, KOL communication, supporting abstracts, publications, papers; pricing and reimbursement for France and for other countries.
Our people:
ClinSearch Experience 2015
ABIR TADMOURI: PhD in biomedical
engineering, PG diploma in biostatistics, PG
diploma in clinical research, currently studying
PG in Health Economics. 7 years of experience in
basic neuroscience research; joined ClinSearch
in 2010.
EVELYNE BOOS: MD with a degree in clinical
oncology, partially completed at Duke.
Experience with the French Sentinelles
network working on the estimation of impact of
vaccination of adults after
exposure to the varicella zoster virus in
France; with ClinSearch since 2013.
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OUR SERVICE LINES:
Monitoring and Project Management
• Extensive experience with clinical and non-interventional studies (post-marketing surveys, cohorts, and registries)
• Ad-hoc, flexible monitoring schemes, ideally suited to a SME
• Multilingual CRA team, easily deployed to any location in Europe and MENA, utilizing the low-budget flights available from Paris
• Centralized project management model, enabling harmonization of all operations and superior quality assurance
• Prowess in regulatory dealings with Europe and MENA.
ClinSearch Experience 2015
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OUR SERVICE LINES:
EDC development, MedDRA coding
ADVANTAGES:
Customization of electronic case report forms (eCRFs)
Web-based platform , providing access for si tes to enter data
Cleaning and locking process on-the-go, in which any queries against the data are resolved at entry
Adaptation of the f inal data to SAS datasets
Cost advantage .
ClinSearch Experience 2015
INCLUDES:
Developing data val idation plan
User training and management
Visual implementation of si te data
Creating alerts
Data cleaning and locking on the go
Data reports
Data safety and repository function
Integrated MedDRA coding.
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OUR SERVICE LINES:
Medical Writing & Statistics
Medical Writing Projects include: • writing all study documents (CRF, PL, ICF, study report); • articles & publication materials, posters & slide kits;• scientific committee management; • translations;• conference attendance and minutes taking.
Statistical Projects include: • statistical study design (sample size calculations, statistical power,
randomization);• statistical analyses plans (SAPs);• statistical reports;• SAS programming.
ClinSearch Experience 2015
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OUR SERVICE LINES:
Site Management/ MDKeys network
MDKeys: a partnership between ClinSearch and more than 70 physicians in 11 hospitals in Eastern Europe and Scandinavia
The role of ClinSearch:•Directly manages the sites, hospital contracts and physician agreements;•Sets procedures specific to MDKEYS;•Deploys specialized CRA speaking local languages;•Ensures quality of collected data.
ClinSearch Experience 2015
ADVANTAGES:
• Epidemiological context;
• High potential for patient recruitment
(centralized healthcare);
• Center audits;
• Clinical Research training;
• Compliance with international laws,
regulations, standards and SOPs;
• Physicians and hospital agreements
in place/ quick start of projects.
9ClinSearch Experience 2015
Anesthesiologists
Cardiac Surgeons
Cardiologists
General Surgeons
Gastroenterologists
Gynecologists/Obstetricians
Interventional Cardiologists
Interventional Radiologists
Neurologists
Oncologists
Orthopedic Surgeons
Spinal Surgeons
Physicians and KOL’s
Countries
Austria
Belgium
France
Germany
Italy
Middle East
(several countries)
Netherlands
Spain
United Kingdom
Bosnia &
Herzegovina
Bulgaria
Croatia
Macedonia
Serbia
Norway
Our Advantages
Highly educated multilingual staff, extensive experience with medical devices, pharmaceutical and biological products
Wide in-house resource base providing seamless service (EDC, medical writing and statistics departments)
Focus on adding value and scientific accuracy, proactive partnering
Medium size, guaranteeing maximum focus on your projects
Competitive and transparent budgeting, including fixed rates per service
Split of risks (malus/bonus).
Our Advantages 201510
Compliance and Certifications
OUR STANDARDS ARE BASED ON• Legal and regulatory requirements by country• ICH — Good Clinical Practice• GHTF and AHWP guidance• Good Epidemiological Practice• Declaration of Helsinki• ISO 9001:2008• ISO 19011:2002• ISO 14155:2011• ISO 13485:2003• ISO 14971:2007
Quality Control department.
Compliance 201511
Contacts
For France:Stephanie Dousa-Callier, Business Development ManagerPhone: +33 1 47 35 13 57 Mob: +33 6 64 46 31 [email protected]
International:Ivelina Georgieva, International Key Account ManagerMob: +420 702 133 [email protected]
Contacts 201512