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CLINICAL QUALITY OVERSIGHT FORUM
5th Annual
Ensuring Trial Integrity by Effectively Assessing, Optimizing and Managing the Quality of Clinical Vendors and Sites
Join the Conversation
Group: Proactive GCP Compliance
EXECUTIVE SUMMARYOctober 5-7, 2015 | Sonesta Philadelphia | Philadelphia, PA
2
CONTENTS
Introduction 3
2014 Session Summaries 4
Resources for Information and Discussion 12
Recommended Service Providers 13
3
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%
4
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.
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
Have you seen (or received) agency inspection findings regarding Quality System Vendor Management and
Oversight citation?
1 2
23%
77%
1. Yes 2. No
Audience Response Question
7
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.
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
How many of you have experience utilizing RBM approaches in clinical trials?
1 2 3 4
31%
5%
36%
28%
Audience Response Question
1. None 2. A little 3. Some 4. All RBM, all day/
every day
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
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
Audience Response Question
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
Does RBM save money?
1 2 3
15%
26%
59%
1. Yes 2. No 3. Not sure
Audience Response Question
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.
8
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
28
■ 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……
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
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
Audience Response Question
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
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
Audience Response Question
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
9
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.
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
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
Audience Response Question
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
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
Audience Response Question
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
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
Audience Response Question
5th Clinical Quality Oversight Forum, Oct 15-17, Philadelphia www.exlevents.com/qualityoversight
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
Audience Response Question
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
12
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
www.exlevents.com/qualityoversight
For more information on this and other upcoming events, please contact
Kristen Hunter at 212-400-6241 or khunter@exlevents.com
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
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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/
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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
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