october 5-7, 2015 | sonesta philadelphia | philadelphia...

CLINICAL QUALITY OVERSIGHT FORUM

5th Annual

Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites

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Group: Proactive GCP Compliance

EXECUTIVE SUMMARYOctober 5-7, 2015 | Sonesta Philadelphia | Philadelphia, PA

https://www.linkedin.com/groups/Proactive-GCP-Compliance-2914634/about

2

CONTENTS

Introduction 3

2014 Session Summaries 4

Resources for Information and Discussion 12

Recommended Service Providers 13

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INTRODUCTION:

5TH CLINICAL QUALITY OVERSIGHT FORUMOctober 15-17, 2014 – Philadelphia, PA

Since research and studies continue to increase in complexity, it’s often necessary to partner with dozens of vendors, utilize multiple

databases and collaborate with numerous parties, making it all the more challenging to demonstrate to regulatory agencies that you have

control and appropriate knowledge of our programs. Having an effective and well-documented oversight strategy that fits your company’s

needs and resources is a critical success factor.

ExL’s Clinical Quality Oversight Forum is a unique interactive outlet for clinical professionals to share, discuss and develop ideas and

strategies for identifying and mitigating clinical risk when working with clinical vendors and sites. This document provides a detailed

overview of the 2014 Forum, outlining the information that was presented and discussed.

The three-day event focused on ensuring trial integrity by effectively assessing, optimizing and managing the quality of clinical vendors

and sites and featured educational sessions, results-driven case studies, dynamic panel discussions, interactive workshops and intimate

roundtables all presented by the industry’s leading experts on clinical quality, management and oversight. Clinical quality oversight was

covered from all angles, answering the broad questions such as why risk-based management and oversight activities are even necessary,

to how effective execution can impact overall clinical performance. It also addressed the more focused aspects of how to integrate effective

oversight tactics into all aspects of vendor and site management, from protocol development to selection process, to monitoring, to clinical

CAPAs. Additional session topics included an overview of outsourcing trends, optimizing clinical oversight through the use of quality

management systems to manage quality and risks, developing a comprehensive audit strategy plan, communication optimization and

management, and many more.

This event always brings together an engaging group of professionals from pharmaceutical, biotechnology and medical device companies,

as well as CROs and other clinical trial service and technology providers, who work in clinical quality and compliance, clinical operations

and management, quality systems development, monitoring, audits and inspections.

Through the use of an audience response system, speakers were able to poll the audience, which provided valuable insight into the

industry’s perceptions, understanding and progress as they related to the topics discussed. Many of these valuable polling results are

included in this document.

Following are session summaries and highlights to give you an idea of the information presented and topics discussed at the 5th Clinical

Quality Oversight Forum.

2014 AUDIENCE BREAKDOWN

70% Pharmaceutical, Biotech and

Medical Device Companies

12% CROs

12% Other Clinical Service

Providers

6% Other

50% Clinical Quality/Compliance

30% Clinical Operations/Management

10% Outsourcing/Vendor Management

5% Audits/Inspections

5% Other

Company Type Department

50%

30%

10%

5%5%

70%

12%

12%

6%

OF THE AUDIENCE REPRESENTED DIRECTOR-LEVEL AND ABOVE 70%

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2014 SESSION SUMMARIES

Chairperson’s Opening Remarks Returning as the esteemed Conference Chair, Sharon Reinhard,

former Director of Clinical Operations and Compliance at iCeu-

tica, Inc., opened the conference by defining why we are here at

the conference:

❖ Staying current with best practices

❖ Learning something new

❖ Connecting with colleagues/ Network

❖ Measuring progress as quality driven employees, companies

and as an industry

❖ Bringing back awareness and change to our organizations

❖ Recapturing our enthusiasm

To learn the perspective of the audience they were asked “How

many trials is your company running?” with just over half

indicating 20+ and a quarter 1-5. Only 37% of the audience

answered “yes” to “Do you feel your organization has adequate

procedures and plans in place to perform oversight?” and only

29% responded positively to “Do you feel your organization has

enough resources to perform oversight?”

“Overview of Outsourcing Trends, Evaluating the Drivers

and Understanding the Impact on Oversight Strategies” was

delivered by Mitchell Katz, PhD, Head of Medical Research and

Drug Safety Operations at Purdue Pharma, and kicked off the

event with a detailed state of the industry, outsourcing trends

and risk analysis. Mitch highlighted that clinical development

now takes longer because of project failures, recommending

that pharma move from traditional trial-and-error and adopt

new paradigms based on biomarkers, modeling and simulation,

novel formulation and adaptive designs. He also discussed the

benefits of risk-sharing partnerships with academic centers

and CROs to help sponsors move toward efficient expertise. He

addressed the fact that more industry-sponsored trials are taking

place in emerging markets, attracted by large number of patients

with a wide range of conditions as well as reduced costs, and

recommended examining off-shoring on a case-by-case basis,

as the risks are also great. He discussed Purdue’s experience

taking the focus off of ex-US study sites and back to the US.

Accentuating the importance of risk assessment and what

specific risks are being assessed, Mitch shared some industry

statistics gathered by research conducted by The Avoca Group.

More information from the same Avoca study demonstrated the

differences in satisfaction with risk assessment and management

performance from in-house teams versus CRO partners on a

variety of factors.

Audience Poll

1 2 3 4

24%

54%

11%11%

1.  1-‐5 2.  6-‐10 3.  11-‐12 4.  20+

How many trials is your company running?

Audience Poll

1 2 3

37%

18%

45%

1.  Yes 2.  No 3. Maybe

Do you feel your organization has adequate procedures and plans in place to perform oversight?

Audience Poll

1 2

71%

29%

1.  Yes 2.  No

Do you feel your organization has enough resources to adequately perform oversight?

28

What Risks are Assessed?

0%

10% 20% 30% 40% 50% 60% 70% 80% 90%

Patie

nt e

nrol

lmen

t risk

s

Vend

or p

erfo

rman

ce

risks

Data

qua

lity

risks

Othe

r tim

elin

e ris

ks

Site

com

plia

nce

risks

Cost

risk

s

Clin

ical

tria

l sub

ject

sa

fety

risk

s

Drug

/dev

ice

supp

ly-

rela

ted

risks

Risk

s to

right

s of

clin

ical

tria

l sub

ject

s/et

hics

Othe

r

Sponsor (N=70) Provider (N=75)

When a systematic risk assessment is performed for projects conducted by your company, which of the following risks are typically formally assessed?

5

Dirk Roels, Director, Quality Assurance Analysis, Pharmaceutical

R&D Q&C of Janssen Pharmaceuticals provided a presentation

on “Identifying Strategic Clinical Vendors and Minimizing

Risks through Effective Qualification.” Dirk discussed the

recent increase in outsourcing due to cost reduction, flexible

workforce, efficiency improvements and the ability to focus on

key competencies. To develop a risk-based vendor assessment

strategy, Dirk recommended documenting all outsourcing

expectations and assigning risk to vendor types and services.

He outlined the basic topics to address with any supplier that

included measurements of success, escalation processes and

pathways, change control mechanisms and client interactions.

He also defined some useful quality assessment hot spots to be

sure to address, gathered from his own experiences.

“Utilizing Protocol Design to Facilitate Quality Oversight and

Optimize Compliance” was shared by Donna Edgerton, Senior

Director, Global Clinical Development, Compliance and Training

at Allergan. She encouraged attendees to recognize the protocol

as a primary tool to facilitate and support quality conduct of a

trial and to examine elements of the protocol that can improve

or detract from compliance, such as writing style/clarity, protocol

feasibility and the number of amendments. The session also

addressed optimizing site education through effective protocol

training and safety reporting processes. She accentuated the

value of internal influence and consistently communicating the

importance of protocol design to improve the overall process and

increase compliance.

A panel discussion on “Optimizing Clinical Oversight through

the Use of Quality Management Systems to Manage Quality and

Risks” was moderated by Katie Alberta of Alkermes, Inc. and

panelists were: Margo Holland, Vertex Pharmaceuticals; Dirk

Roels, Janssen; and Kevin Wilson, Eli Lilly. Panel topics included

the definition of quality management system (QMS) as well as

examples of effectively using a quality management system to

monitor organizational performance and trial execution of vendors

and sites. Almost unanimously, 98% of the audience believe

that during inspections, Regulatory Agencies are evaluating the

QMS, specifically the quality systems for vendor oversight, with

77% indicating they’ve seen or received agency inspection

findings regarding quality system vendor management and

oversight citation.

33

Satisfaction with Risk Assessment and Management Performance

Scale of 1 to 5; 1=Very dissatisfied, 5=Very satisfied In-

House Teams

CRO

Partners

Appropriateness of measures suggested or taken in reaction to risk-related information

3.5 2.9

Communications regarding risk-related trial information

3.4 2.8

Compilation of risk-related trial information during a trial (observations, trends, etc.)

3.4 2.8

Frequency of review of risk-related trial information 3.5 3.0

Overall performance on risk assessment and management related activities

3.5 2.8

Proactive identification of potential risks 3.8 3.0

Proactive risk analysis and evaluation 3.4 2.8

Rigor of review of risk-related trial information 3.3 2.6

Protocol as Quality Tool

•  While it must serve many purposes, a primary purpose of the protocol is to guide acFon through clear and unambiguous instrucFons –  Content supports decision making, –  Prevents errors in the study –  Provides enough informaFon to help the reader understand risks and costs

–  Clearly idenFfies requirements vs. recommendaFons –  Internally consistent-‐ avoid repeaFng instrucFons in mulFple places

9

Our Goals: Op9mize Protocol Development, Feasibility, & Training

•  Project-handover process •  Quality management system – Structure; Staffing; Training

•  Vendor management & subcontracting •  Staff turn-over •  Which SOPs & forms to be used •  QA unit

Due to the positive feedback and engaging nature of this valuable discussion on QMS, it will be repeated at the 2015 event with participants from ABBVIE, UCB BIOSCIENCES, APPIAN CORPORATION and ELI LILLY.

6

“Recognizing Scientific Quality Measurement, Developing a

Program of Quality Management and Utilizing Quality Measures

to Manage a Clinical Trial” was the subject of the next session

offered by Michael J. Howley, PhD, Associate Clinical Professor,

Business at Lebow College of Business at Drexel University. He

defined quality as an evaluation of how well the trial is conducted

relative to expectations and discussed the value of predictive

modeling and scientific quality measurement to increase quality,

speed and efficiency as well as reduce the cost of clinical trials.

The next session was a “Pfizer Case Study on The Development

and Early Implementation of a New Site Health Assessment

Program Identifying Risk Utilizing Predictive Analytics”,

presented by Cheryl Small, Executive Director and Area Head,

Americas – Clinical Trial Support & Compliance, Worldwide

Research & Development at Pfizer. Cheryl’s presentation focused

on Pfizer’s initiative to manage quality from clinician to patient in

a partnership model. She accentuated that as a sponsor, Pfizer

is responsible for ensuring appropriate oversight of all trials, and

that their oversight is structured around two elements, assessing

site level trial conduct and assessing the quality of monitoring.

Pfizer is focused on driving site health evolution through a more

evolved approach to the way that they deploy resources, manage

risks and issues, and identify trends. They are leveraging their

data to identify what factors determine a high quality investigator

site, proactively determine expected error rates, and predict

outcomes, and then successfully executing data-driven decisions

regarding their oversight practices.

John R. Wilson, Jr., PhD, Senior Vice President of Beaufort

LLC, shared another case study on “Realizing the Operational

Benefits of Utilizing a Third-Party Quality Oversight Program.”

John explained that this case study came about because the global

pharmaceutical firm needed assurance that their trial was being

conducted appropriately, actionable data and information with

an eye toward early process improvement, and documentation of

appropriate oversight of the CRO. They chose to use a third party

because the sponsor didn’t have appropriate global resources or

a quality oversight plan. John outlined the details of the case and

how the objectives were achieved by work performed through a

comprehensive program plan, highly trained assessors, quality

oversight visits, and data analytics and real time reporting.

Significant value was provided to the firm through early process

improvements and meeting regulatory agency expectations for

oversight of vendors.

5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight

Do you believe that Regulatory Agencies are evaluating QMS’s and more specifically quality systems for Vendor

Oversight during inspections?

1 2

2%

98%

1.  Yes 2.  No

Audience Response Question

MANAGING QUALITY FROM CLINICIAN TO PATIENT IN A PARTNERSHIP MODEL

Controlling Pfizer’s quality through process excellence [Centrally managed resource]

Sponsor PracRces

Safeguarding the quality of Pfizer’s inves<gator sites [ Field-‐based resource]

InvesRgator Sites

Data Integrity Protocol Adherence Patient Safety

Clinical Trial Quality

© 2014 Pfizer Inc.

Site Health -‐ Beyond counRng to PREDICTING OUTCOMES

Oversight Visit Issue Counts

Level 1 Audit Findings

Protocol Devia-on Module

SAE Module

Staff Turnover Module

Data Timeliness Module

Overall Site Health Metric

STATISTICALLY CORRELATED

ProacRvely determining expected error rates using relevant variables within 4 Modules – see trends before we have a finding

Each Modules has covariates that drive expected values. Examples: paRent count, country, TA, etc.

© 2014 Pfizer Inc.


Have you seen (or received) agency inspection findings regarding Quality System Vendor Management and

Oversight citation?

1 2

23%

77%

1.  Yes 2.  No


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The first day concluded with a panel on risk-based monitoring

(RBM) focused on “Identifying and Managing Risk by Leveraging

Clinical Data to Target Monitoring Efforts.” The moderator was

Kathy Goin of Trevena, Inc. and panelists were: Duncan Hall

of Triumph Research Intelligence; Mitchell Katz of Purdue

Pharma; Rivka Kerachsky of Theorem Clinical Research; Linda

Sullivan of Metrics Champion Consortium; and Howard Waxman

representing the Investigator Site. When the audience was

asked whether they had experience utilizing RBM approaches in

clinical trials, nearly one-third reported that they had “none” with

28% indicating “a little” and 36% with “some”. 57% reported

that “getting to understand how to do it” is the most significant

challenge in undertaking RBM approaches with 43% choosing

“integrating the data to make decisions.” An overwhelming 59%

of the audience indicated that RBM does NOT save money.

The panel offered their best practices for mapping out the RBM

process and definitions of what success looks like.

For her day two introduction, chairperson Sharon Reinhard

recapped some of the main themes from the previous day, noting

that most organizations report needing smarter and simpler

processes and plans, more resources and better documentation.

Also commenting that the quality of protocols has significant

impact on vendor performance, site performance and data, and

that although technology and metrics can add value, they cannot

replace people, experience and knowledge.

“Designing a Comprehensive Audit Consisting of Multiple In-

process Vendor Audits and Internal Process Audits to Effectively

Determine Compliance and Performance” was the focus of a

comprehensive audit strategy case study from Angela Berns,

Director and Head of Vendor Management, Clinical Quality

Assurance at UCB Biosciences, Inc. Laying the ground work for

the case, she outlined varying outsourcing models, defined a risk-

based quality management program, discussed the elements of

a master audit plan, the audit strategy and how to develop an

annual risk-based audit schedule that should be reviewed and

adjusted as needed. She discussed what types of risk should

translate into audit targets and that critical elements to success

are the development of an effective assessment team to conduct

and manage the audits, as well as the ability to identify and

measure the outputs and deliverables of the audit.


How many of you have experience utilizing RBM approaches in clinical trials?

1 2 3 4

31%

5%

36%

28%


1.  None 2.  A little 3.  Some 4.  All RBM, all day/

every day


What is the most significant challenge in undertaking RBM approaches?

1 2

43%

57%1.  Getting to understand how to do it

2.  Integrating the data to make decisions



Does RBM save money?

1 2 3

15%

26%

59%

1.  Yes 2.  No 3.  Not sure


Taking this discussion to the next level, representatives from SHIRE, VERTEX and Vital Therapies compare their experiences with risk-based, centralized and remote monitoring methodologies and share practical tips for effective execution during a panel at the 2015 forum.

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Next was a panel on effective clinical auditing focused on

“Developing and Executing an Audit Strategy as an Effective

Oversight Tool and Using the Findings to Generate Action

Plans to Mitigate Risk.” The panel moderator was Kevin

Wilson of Eli Lilly & Co. and panelists were: Angela Berns of

UCB Biosciences, Inc.; Nicky Dodsworth of Premier Research;

Jessia Lee of Inovio Pharmaceuticals, Inc.; and Cheri Wilczek

of Clinaudits, LLC. During this comprehensive discussion on

audit plans and risk-based audit approaches, the panel asked

the audience “Does your company/organization have quality risk

management processes established that can be used for risk-

based auditing?” 38% said “yes,” 49% said “no” and the rest

were uncertain. When asked “What is the current perspective on

risk-based auditing approaches at your company/organization?”

49% responded with serious consideration and 47% indicated

some consideration.

At this point in the conference the program splits into two tracks,

offering participants the choice of sessions. Shared during Track

A was a case study on quality agreements, Margo Holland,

Director, Quality Assurance, GCP of Vertex Pharmaceuticals,

Inc. delivered details on “Developing an Effective Quality

Agreement with Your Clinical Partner to Optimize Performance

and Minimize Risk.” She discussed quality agreements as

tools to enable regulatory compliance and allow for sponsor

oversight, by drawing attention to “Risks that Matter”, allowing

for efficiencies, preventing redundancies and enhancing

human subject protection. She highlighted that the higher the

compliance, exposure and complexity risks, the greater the

need for a quality agreement. She outlined varying approaches

to quality agreements, with one all encompassing agreement

versus a division between operations and QA. She outlined the

critical elements of the quality agreement as defined roles and

responsibilities, escalation path and timelines, communication

plan, metrics and quality assurance activities/collaboration.

Margo concluded by accentuating that quality agreements do not

guarantee quality, they are only as good as they are implemented.

Types of risk which translate into audit targets

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■ Data integrity •  Data corruption or loss •  Data migration issues •  Data analysis/ processing •  Validation, testing

■ Patient safety •  Interruption to IP supply chain •  Poor monitoring leading to deviations to inclusion/exclusion criteria

and non-compliance with protocol •  Add more…

■ Regulatory compliance •  Late reporting of safety data •  Add more……


Does your company/organization have Quality Risk Management established that is used/can be used for

risk-based auditing?

1 2 3

38%

13%

49%

1.  Yes 2.  No 3.  I don’t know



What is the current perspective on risk-based auditing approaches at your company/

organization?

1 2 3

4%

49%47%1.  No consideration 2.  Some

consideration 3.  Serious

consideration


Base Determination on Risk

9/23/14 Copyright Margo Holland 9

v Compliance Risk Ø How critical is the study to your

regulatory filing or label? v Exposure Risk

Ø How many studies could this Vendor impact if things went wrong?

Ø How many programs?

v  Complexity Risk Ø Study design Ø Study procedures Ø Study populations

As risk so does the consideration for a QA2QA Agreement

“The conference and speakers were all excellent. This was a very valuable conference and input from the participants will improve our quality oversight of vendors.”

- Brandy Schenck, Auditor, Quality Assurance, INFINITY PHARMACEUTICALS

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Also during Track A was Jennifer J. Poulakos, PhD, Director of

Development Quality Assurance at Agensys Inc., an affiliate of

Astellas Pharma, Inc., who offered a session on “Communication

between Sponsor, CRO and Investigator Site to Optimize Trial

Integrity.” She outlined the importance of a communication plan,

indicating when there is clear communication of meaningful

information, the result is compliance with requirements and the

output is consistent, reliable and accurate. She then defined the

purpose and benefits of an effective communication/governance

plan. She recommended that communication strategies should

always include a kickoff meeting for sponsors and clinical vendors

to review key status reports, the establishment of authorship/

document responsibilities for study plans, development of a

partnership with clinical quality assurance for vendor audits, and

a vendor monitoring program. She shared several case studies

articulating the importance of communication to mitigate risk.

Meanwhile during Track B, the first session addressed

“Overcoming Oversight Challenges in Small to Mid-size

Companies by Leveraging Resources, Data and Tools” and was

presented by the conference Chair, Sharon Reinhard. When she

asked the audience, “How confident are you that your company

will get through a sponsor inspection with regards to having

performed adequate oversight?” 38% responded “uncertain,

likely to receive a 483” while only 29% were 100% confident,

with the remaining 33% indicating “fairly confident but may

receive a 483.” Sharon explained that oversight is proof that you

had real-time knowledge of a study conduct versus an audit or

review after the work is complete. She went on to outline that at

smaller companies, there isn’t the benefit of multiple dedicated

resources, fancy databases and big budgets, so effective risk-

analysis is key to determining where errors and challenges can

occur, and then direct the allocation of the available limited

resources accordingly to optimize the oversight strategy. She

also accentuated the importance of determining what skillsets

you have within your company versus what elements you may

need to outsource to conduct the oversight. She outlined several

simple tools that any small company can implement, and went

into valuable detail on each one.

Communication/Governance Plan

•  Advanced planning is a worthwhile investment to ensure Quality outcomes

•  Allows all team members (far and wide) access to defined expected standards

•  Metrics provide defined objective measures for benchmarking and ongoing monitoring

•  Mechanism for continuous improvement •  Prospectively identifies issues important for

oversight and potential escalation to senior management

12

Approach to Quality Agreements

Division between operations and QA

One all encompassing Quality Agreement

9/23/14 Copyright Margo Holland 10

Master Quality Agreement

Clinical Quality Agreement

Operational Team 2 Operational Team

Additional Quality Agreements with 3rd

party Vendors

Quality Assurance to Quality Assurance

Agreement QA2QA Only

Quality Agreement

Inclusive of all Quality activities

QA/QC/Operations

AUDIENCE POLL

5

1 2 3

29%

38%33%1. 100% confident

2. Fairly confident, but may receive a 483

3. Uncertain, likely to receive a 483

How confident are you that your company will get through a Sponsor inspection with regards to having performed adequate oversight:

Setting Up For Success

•  Perform a risk-analysis of your program to determine where errors or challenges can occur and rank the risks in order of impact, examples: –  Poor patient/subject compliance with electronic diary –  Poor study drug compliance –  Errors in screening subjects –  Failure to monitor the study at appropriate intervals –  Under-reporting of adverse/serious adverse events

•  Determine what skill sets you have within your company versus what skills may need to be “rented” to conduct oversight

–  Yes, you can “outsource” the oversight!!

11

Is internal communication also an issue for you? Representatives from

Merck, Shire and Acceleron Pharma discuss Establishing Effective Communication Channels and Synchronizing Processes Between Clinical Quality and Operations Teams at the 2015 forum.

10

Following on Track B, Kimberley Feir Brooks, RN, BSN, RQAP,

former Quality Oversight Program Lead at Durata Therapeutics,

offered a virtual company case study called “A Small Company’s

Perspective: Two-Year Design, Implementation and Management

of an International Risk-Based Quality Oversight Program.”

The clinical program she highlighted was complex, pivotal,

randomized, and included double dummy and double blind.

Objectives for the program included: demonstrate oversight, risk

identification and mitigation, uniformity and consistency, and

trending. Key performance indicators were identified for the CRA

and site and included protection of subjects, project knowledge

and proactive issue resolution. Quality measurements were

also defined at the site and CRA levels. Resourcing challenges

included global staffing, minimum credentialing standards and

time allocation.

At this point in the program the general session reconvened

with a follow-up case study from the previous year’s conference

titled “One Year Later: Global Functional Service Providers

(FSP) Model” shared by Karen Koroly, RN, BSN, Clinical Site

Management, Oversight Manager at Amgen. Karen explained

that functional service providers (FSPs) contribute to Amgen’s

clinical trial execution platform and allow for increased elasticity

in resourcing, centralization/standardization of processes, and

wider access to highly trained talent pools. The FSP model has

been implemented in clinical operations, study management, data

management, statistical programming and pharmocovigilance.

She identified training as a critical success factor for FSP

implementation, ensuring a global CRA workforce with the

right level of proficiency in relation to sponsor processes and

expectations. She discussed the key development of a site quality

trigger process which has helped improve oversight through early

identification of quality issues at a site, ensuring actions taken

to address issues are consistent, and increasing confidence that

issues are identified and appropriate actions are being taken to

ensure subject safety and improved quality/resolution of issues.

She concluded by stating that setting clear expectations and

maintaining open communication within established governance

pathways allows for high levels of confidence in the relationship

and performance of your partners.

Quality Measurements- Site

•  Number of subjects appropriately consented or re-consented

•  Number of protocol violations per subject •  Data entered into EDC according to study

specific parameters

•  Serious or alarming adverse events reported within 24 hours of discovery

Quality Measurements - CRA

•  Number of open action items closed within 60 days of identification

•  Number of eCRF queries closed within 5 days

•  Percentage of monitoring visits completed per monitoring plan

•  Number of trip reports issued per the

monitoring plan

Simple Tools

•  Any small company can implement the following tools: –  Oversight Strategy Table –  Simple Vendor Questionnaire –  Vendor Qualification Assessment:

•  Agenda •  Report

–  Key Personnel Assessment Form –  Vendor SOP Review Form –  Log of Key Documents Reviewed –  Sponsor Oversight Plan

21

Due to the interactive nature and popularity of the Track B sessions on

topics relevant for smaller companies, Sharon Reinhard has partnered

with Katie Alberta of Alkermes to lead a half-day interactive workshop

on Quality Management Systems at Small to Mid-Sized Companies at

the 2015 forum.

The Metrics Champion Consortium (MCC) will also be sharing the never

before presented results from their Industry Survey of Small to Mid-Sized Companies so you can benchmark your outsourcing strategy, QMS

development and oversight challenges against companies of similar size.

11

The event concluded with a panel discussion on inspection

readiness offering information on “A Retrospecitve Examination

of How Oversight Techniques Could Have Been Improved to

Optimize the Inspection Experience.” The moderator was Donna

Edgerton of Allergan and panelists were: Dwayne Brazelton of

Macrogenics, Inc; Janis L. Hall of The Avoca Group.; John R.

Wilson, Jr,. of Beaufort LLC, who shared their experiences with

inspections and various outcomes. In an audience survey, 63%

reported that they had undergone one to five sponsor/service

provider-focused GCP inspections in the past five years, and

47% reported 1 to 10 site-focused GCP inspections in the past

five years. 63% of the audience indicated they received findings

related to the oversight of outsourced work or clinical sites, and

of the companies that use risk-based monitoring practices, 65%

said they didn’t make organizations more inspection-ready.


How many Sponsor/Service Provider focused GCP inspections have you experienced over the past

5 years?

1 2 3 4

21%

3%

13%

63%1.  0 2.  1-5 3.  6-10 4.  >10



How many Site focused GCP inspections have you experienced over the past 5 years?

1 2 3 4

26%

8%

18%

47%1.  0 2.  1-10 3.  11-20 4.  >20



In any of your GCP inspections have you (sponsor/service provider) received findings related to oversight of

outsourced work or clinical sites?

1 2

38%

63%

1.  Yes 2.  No



If your organization currently utilizes risk-based monitoring practices, do you feel that they make your

organization more inspection ready?

1 2

65%

35%

1.  Yes 2.  No


For more detailed information on the topic of inspection readiness,

participate in a full-day interactive seminar on Effectively Preparing for Tough MHRA Inspections on October 5th as part of the 6th Clinical

Quality Oversight Forum.

Are these topics of interest to you? Hear updated information and engage in discussion on many of these same topic themes at

the upcoming 6th Clinical Quality Oversight Forum, taking place October 5-7 at the Sonesta Hotel in Philadelphia.

For more information visit www.exlevents.com/qualityoversight

www.exlevents.com/qualityoversight

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RESOURCES FOR INFORMATION AND DISCUSSION

PROACTIVE GCP COMPLIANCE ONLINE DISCUSSION GROUP

Discuss the topics addressed during this conference as well as other GCP-related subjects by becoming a member of the

Proactive GCP Compliance LinkedIn® Discussion Group. With 3500 members, this active group offers a valuable forum

for learning from and engaging with like-minded professionals all focused on optimizing clinical quality management and

improving clinical performance. Use this forum to ask questions, share best practices, link to relevant articles and white papers

and learn from one another.

Click here and request to join.

UPCOMING EVENT


For more information on this and other upcoming events, please contact

Kristen Hunter at 212-400-6241 or [email protected]

CLINICAL QUALITY OVERSIGHT FORUM

6th Annual October 5-7, 2015 | Sonesta Philadelphia | Philadelphia, PA

Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites

NEW SESSIONS IN 2015❖ Pfizer Case Study on Clinical Quality Metrics

❖ Vertex Case Study on Data-Driven Compliance

❖ Merck Case Study on Vendor Communication Plan

❖ Documenting Vendor Oversight

❖ Evaluating Recently Issued FDA Warning Letters

❖ Quality Oversight of Late-Phase Research

❖ Optimizing Data Quality by Combining RBM and Oversight Strategies

❖ Clinical CAPAs

❖ Risk-Based Auditing

❖ Escalation Plans

PRE-CONFERENCE DAY

OCTOBER 5TH INTERACTIVE LEARNING DAY

FULL-DAY SEMINAR MHRA INSPECTIONS

HALF-DAY WORKSHOP QMS AT SMALL TO MID-SIZED COMPANIES

HALF-DAY WORKSHOP TMF AS AN OVERSIGHT TOOL

mailto:[email protected]

https://www.linkedin.com/groups/Proactive-GCP-Compliance-2914634/about


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RECOMMENDED SERVICE PROVIDERS

APPIAN

As the market leader in modern Business Process Management (BPM) and Case Management software, Appian

delivers an enterprise application platform that unites users with all their data, processes, and collaborations—in

one environment, on any mobile device, through a simple social interface. On-premise and in the cloud, Appian

is the fastest way to deliver innovative business applications.

Website: http://www.appian.com/

CLINAUDITS

ClinAudits is a truly independent organization providing auditing and compliance consulting services domestically

and throughout the world. Continuing for over 20 years, clients receive customized services requiring expertise

and direct experience with GCP, GTP, GMP, GLP, REMs, tobacco and animal health. All activities are coordinated

centrally from our offices in northern New Jersey. Regionally based, senior-level auditors conduct on-site or remote

audits and other compliance services relating to pre-clinical research through Phase 4 development programs,

and onto commercialization of products. Be it a need to address a single, immediate QA event or to serve the

complete QA function, ClinAudits’ approach is to clarify the specific need and then develop and implement an

effective plan, all while delivering exceptional quality, service and value.

Website: http://www.clinaudits.com

CLUEPOINTS

CluePoints is a Central Statistical Monitoring solution that has been designed and perfected over the last 12

years. It employs unique statistical algorithms to determine the quality, accuracy and integrity of clinical trial and

operational data both during and after study conduct. Aligned with guidance from the FDA and EMA, CluePoints

is deployed to support traditional on-site monitoring and can be implemented as the engine to drive a Risk-Based

Monitoring strategy. The value of using CluePoints® lies in its powerful and timely ability to identify anomalous

data and site errors allowing improvement in clinical data quality, optimization of on-site monitoring and significant

reduction in overall regulatory submission risk.

Website: http://www.cluepoints.com/

KPS LIFE

KPS is a global, innovative, clinical outsourcing provider delivering clinical trial monitoring, management and

quality oversight services to pharmaceutical, biotechnology, medical device, and related industries. Founded and

operated as a more customer centric and nimble alternative to traditional CROs, KPS offers a full range of services

leveraging the latest clinical technologies.

Website: http://www.kpslife.com/

http://www.kpslife.com/

http://www.cluepoints.com/

http://www.clinaudits.com

http://www.appian.com/

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TRIUMPH

Built on the foundation of 13 years of consulting experience exclusively dedicated to the life sciences industry, TRI

holds a number of firsts. TRI is the first company entirely focused on risk-based monitoring and clinical quality

oversight, and the first to create and offer a purpose-built RBM platform, termed OPRA. TRI is the first company

to offer a holistic approach to RBM providing a full solution to any company wishing to successfully implement

risk-based monitoring. Specifically, to accompany OPRA, TRI offers the knowledge, services and overall expertise

to address the change, processes and management required when implementing an RBM solution.

TRI – Where’s The Risk?

Website: http://tritrials.com/

ZIGZAG ASSOCIATES

Zigzag Associates Ltd is a Global Quality Assurance (‘QA’) consultancy company based in the UK, who can provide

a team of highly experienced QA professionals to support you. Whether you need ad hoc support, a more regular

commitment through outsourcing, or an experienced team to partner with on audit programs, we can offer you

a flexible, pragmatic and responsive global service tailored to suit your requirements. We specialize in audits,

inspection readiness, Quality Management Systems and training.

Website: http://www.zigzag.eu.com

ABOUT EXL EVENTS

ExL Events, Inc., (aka “ExL Pharma”) develops engaging, content-driven conferences and partnered events for

dynamic industry audiences including: Pharmaceutical, Biotechnology, Medical Device, Diagnostic, Contract

Research Organization, Hospital Networks, Physicians, Communications and others. Behind our diverse event

portfolio, our experienced team conducts extensive market research and targeted outreach. The results translate into

innovative, high-quality events that facilitate the exchange of critical information between industry professionals

and suppliers who support shared goals.

Our events are the preferred resource for important topical information and networking opportunities with a clear

delineation between content and commercialism. Our mission is to bring allied industries together to discuss and

strategize on key issues and challenges resulting in the implementation of new ideas, strategies, tactics and key

learnings that facilitate the pursuit of their missions which in many cases is to help improve the lives of patients

and improve outcomes.

Website: www.exlevents.com

RECOMMENDED SERVICE PROVIDERS CONTINUED

www.exlevents.com

http://www.zigzag.eu.com

http://tritrials.com/