The document summarizes an upcoming two-day conference on operational excellence in clinical trials taking place March 12-13, 2014 in Berlin, Germany. It outlines the conference agenda, topics, and speakers. Over 20 speakers are listed from pharmaceutical and clinical research organizations who will address topics like study feasibility, patient recruitment and retention, social media in recruitment, clinical project management, and conducting global clinical trials. The document provides an overview of the conference objectives, sessions, and opportunities for networking and discussion between professionals in clinical operations and research.

1. www.kp-morgan.com / info@kp-morgan.com
OECT Summit 12th – 13th March 2014, Berlin, Germany
Two Days Conference
Speakers Include:
Jo Burmester,
Director Global Operations,
PharmaSchool Ltd.
Klaus Beinhauer,
Regional Head Global
Monitoring and Site
Management EU
Kai Langel,
Founder and Director,
eClinical Health
Pieter Proot,
Senior Global Trial Leader,
Novartis.
Pete Chan,
Chief Innovation Advocate,
Tudor Reilly Health
Urban Olsson,
Clinical Development Manager,
AstraZeneca
Philippe Auby,
Divisional Director Paediatrics
and CDC, Lundbeck
Dr Ulrike M. Grimm
Vice President, Global Clinical
Operations, Vifor Pharma
Wolfgang Summa,
Vice President of outcomes
delivery and support, ERT
Michaela Kroeger,
Performance & Metrics Lead,
Global Clinical Operations,
Merck Serono.
Aleksandra Jankielewicz,
Clinical Director, Head Europe
North/Central/East Site
Management & Monitoring,
Abbvie
Sanja Bordessoule,
International Clinical Trial
Manager,
Sanofi
Iva Dumbovic Dubravcic,
Clinical Trial Manager,
Roche
Rosamund Round,
Associate Director Patient
Recruitment, Parexel
International
Lydia Dorrego,
Former Clinical Operations
Director, Spain
Yamin Khan, Executive Vice
President Clinical Development,
Pharm-Olam
Jolanta Bilinska, Head of
Department of International
Cooperation National health
Fund Lodz, International
Alliance of Patients
Organizations chair elect
and President Patient Safety
Foundation Poland.
Chairman: Jo Burmester, Director Global Operations, PharmaSchool Ltd & Editor The Journal of
Clinical Research & GCP
Operational Excellence
in Clinical Trials
Summit
Study Feasibility, Patient
Recruitment Retention and Social
Media in Patient Recruitment
12th
– 13th
March 2014,
Berlin, Germany
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2. OECT Summit 12th – 13th March 2014, Berlin, Germany
Two Days Conferencewww.kp-morgan.com / info@kp-morgan.com
Operational Excellence
in Clinical Trials Summit
12th – 13th March 2014,
Berlin, Germany
Topics at a Glance: You should not
miss this annual
opportunity
if you are –
Chiefs, Directors,
Heads, Senior
Manager, Leaders
and Executives from
Clinical Operations, Clinical
Developments/Research, Clinical
Trials, Clinical Program, CPM, Study
and Feasibility Management, Global
Monitoring Operations, International
Clinical Research, Patient Recruitment
& Retention, Medical Operations,
Medical Affairs, Medical Advisors, MSL,
Data Management, Compliance and
Regulatory
A basic fact about clinical trial
research:
“Even though a study may be very
well designed and funded,
it cannot bring a drug to market
without the availability of suitable
subject.“
Got a question?
Contact Mr. Andreas Raab
andreas.raab@kp-morgan.com
Tel: +35 31 437 85 75
Web: www.kp-morgan.com
Study Feasibility
• Risk assessment
• Operational risk and competitive risk within
study feasibility and site selection
• Site Selection and Activation
Clinical Project Management –
Communication between sites, CROs &
Patients, Investigators, Clinical Trial Teams
• Importance of effective communication
between sponsor - CROs – sites
• Establishing long run relations between the
site
Risk/Centralised Monitoring
• Effect on quality of the trials
• Impact on patient recruitment
Evaluating the Study budgets
• Minimizing the unpredictable environment on
budget perspective or business perspective
• Minimizing the confusions between sponsors
& physicians/sites/labs
• How to stay ahead with study budgets in
competitive environment
KPIs - Speed, Cheap & Quantity
Patient Recruitment and Retention
• Future of patient recruitment in 2015 and
beyond
• Relationship management in recruitment and
retaining of the patients
• How and why current industry is driven by
patients
• Site staff motivation
• Monitoring plan triggers related to the patient
R&R
• How to maximize study participation
Effectiveness Questionnaire and Data
Management
• Setting up effective questionnaire and
dividing a study feasibility questionnaire
• Privacy and security of personal health
information
Clinical Trial Data Capture – balancing quality,
speed and cost
Clinical Outcome Assessments/ePRO
(electronic Patient-Reported Outcome)
Methods
Successsfully Implementing Global Clinical
Trials using eCOA
Paediatric Clinical Trials: why are they
different?
Outsourcing strategies - Patient recruitment
challenges when studies are outsourced
Implementation of Business Models in Clinical
Trials – Patient Recruitment and Retention
Engagement of Investigators in Business
Models or Clinical Trial protocols
Social Media in Patient Recruitment -
Facebook, blogs, SMS & Advertisement
through Online Communities
• What role can social media play in improving
patient enrolment through clinical sites?
• Patient attitudes and best practices in the
social media recruitment space
• Driving the patients traffics from other
websites, blogs, community sites to Pharma
companies local websites
Digital strategies within the Patient
recruitment and retention
Regulatory/Government Support and
Strategy
Best Models for Site Operations
Latest trend in Clinical Trials and importance
of technology in patient recruitment
• Use of Smartphone apps are increasing in
popularity
• Testing a cheaper way to do clinical research
• How to translate technology/databases
knowledge into identification of patients and
attracting them to clinical trials – current
challenges and opportunities
• Involvement of new technology in forecasting
the result of the clinical trials
Patient Recruitment in Emerging countries
and Challenges for Global Trials
• Challenges for Global Trials and changing
regulatory environments
• Innovative Ideas for Global Patient Recruitment

3. OECT Summit 12th – 13th March 2014, Berlin, Germany
Two Days Conferencewww.kp-morgan.com / info@kp-morgan.com
Session I 9:15hrs
Risk Based monitoring – Its impact on Patient Recruitment
Jo Burmester, Director Global Operations, PharmaSchool Ltd.
Session II 10:00hrs
Paediatric Clinical Trials: why are they different?
Philippe Auby, Divisional Director Paediatrics and CDC, Lundbeck
• New Regulatery Framework
• Recruitment Challenges
• Case Study: Psychopharmacology Case Studies
10:45hrs Networking Tea & Coffee with Continental
Breakfast
Session III 11:15hrs
How online patient-centric platforms will transform the way
clinical trials are done
Kai Langel, Founder and Director, eClinical Health
Special Feature 12:00hrs
Insight on: Informed consent - it’s role in subject recruitment and
retention Jo Burmester
Interactive Discussion 12:30hrs
• How much information should we really be giving patients?
• Do we make our protocols too restrictive?
• Would you personally take part in a clinical trial?
• What are the ethical issues with recruiting patients in developing
countries?
Panellists: Philippe Auby, Rosamund Round, Pieter Proot, Urban Olsson
13:00hrs Complimentary Lunch
Session IV 14:00hrs
Enrolment and Retention in a Large Diabetes Study
Pieter Proot, Senior Global Trial Leader, Novartis
• Enrolment challenges & how to manage them
• Use of generated data to enhnace enrolment in the study
• Retention Strategies
• Case Study: Type 2 Diabetes Study(Long-Term)
Session V 14:45hrs
Using online tools to accelerate clinical trial recruitment
Pete Chan, Chief Innovation Advocate, Tudor Reilly Health
• Digital trends, the rise of the epatient and a key tipping point in
how patients receive information about clinical trials
• How pharmaceutical-sponsored disease awareness and clinical
trial websites can accelerate patient recruitment; lessons from
recent online recruitment programmes in mental health
• Advantages of independent online health communities versus
pharma-sponsored sites
• How big data can transform the planning and implementation
of clinical trials; highlights from Tudor Reilly Health’s ePatient
InsightsTM analysis in non-small cell lung cancer; how to reach
epatients in a digitally smart way
• Case Study: PracticalAlzheimers.com, Hepatitiscnews.com
15:30hrs Networking Tea & Coffee with Bakery Delights
Session VI 16:00hrs
Global Clinical Studies, Patient Recruitment Challenges and
Observations
Urban Olsson, Clinical Development Manager, AstraZeneca
• Clinical Project Management
• Clinical Outcome Assessments/ ePRO methods
• Patient Recruitment in Emerging Countries and Challenges for
Global Trials
Session VII 16:45hrs – Special Feature
Insight on: How and why current industry is driven by patients
Rosamund Round, Associate Director Patient Recruitment,
Parexel International
• Changing Environment
• Advocacy Group Movement
• Online Communities
Session VIII 17:05hrs
Overcoming Challenges in Emerging Markets
Yamin Mo Khan, Executive Vice President Clinical Development,
Pharm-Olam
• Should we conduct trials in THEK regions?
• Abundance of Patients - A good thing?
• Logistical, Legal and Financial Hurdles
Open Discussion Panel 17:35hrs
Closing Remarks by Jo Burmester, Director Global Operations
PharmaSchool Ltd 18:05 hrs
18:10hrs Cocktail Reception
All attendees are welcome to join at the complimentary cocktail
reception. An extended opportunity to network and benchmark.
DAY 1
8.15 - 9.00
Registration/ check in with tea and coffee
Opening Remarks by Chair – Jo Burmester,
Director Global Operations, PharmaSchool Ltd & Editor
The Journal of Clinical Research & GCP

4. OECT Summit 12th – 13th March 2014, Berlin, Germany
Two Days Conferencewww.kp-morgan.com / info@kp-morgan.com
Session IX 9:15hrs
Clinical Project Management and Sponsor Oversight
Dr Ulrike M. Grimm, Vice President, Global Clinical Operations,
Vifor Pharma
• KPI’s-benchmarks-dashboards
• Implementation of efficient communication processes
• Risk Management
• Escalation Process
Session X 10:00hrs
Successsfully Implementing Global Clinical Trials using eCOA
Wolfgang Summa, Vice President of outcomes delivery and
support, ERT
• Collecting your eCOA data on a Global Scale
• Picking the right technology solution for your trial based on
Ptaient population, IT infrastructure of participating countries,
validation status of used instruments(Linguistic and Modality)
• Global Support: Translations/Linguistic validation, Submission of
Ethics committees, Logistics / Hardware, Training, Helpdesk
10:45hrs Networking Coffee Break With Continental
Breakfast
Session XI 11:15hrs
KPI’s – Speed, Cheap & Quality
Michaela Kroeger, Performance & Metrics Lead, Global Clinical
Operations, Merck Serono
Session XII 12:00hrs
Improving Clinical Study Site Productivity
Aleksandra Jankielewicz, Clinical Director, Head Europe North/
Central/East Site Management & Monitoring, Abbvie
Interactive Panel Discussion 12:45hrs
• Will Risk Based Monitoring be good or bad for patient
recruitment?
• Is it ethical to use social media to recruit patients?
• How can we get the balance between encouraging recruitment
and coercing patients or encouraging fraud?
• Why do patients withdraw from clinical trials?
Panellists: Ulrike Grimm, Aleksandra Jankeilewicz, Pete Chan
13:15hrs Complimentary Lunch
Session XIII 14:15hrs
Future of Patient Recruitment: Meeting the needs of Patient
Rosamund Round, Associate Director Patient Recruitment,
Parexel International
• Embracing Technology
• Enhancing communication
• Exploring other industries
Session XIV 15:00hrs
Title: Clinical Development Plan
Former Clinical Operations Director, Spain
15:45hrs Networking Coffee Break With Bakery Delights
Session XV 16:15hrs
Patient Empowerment in Clinical Trials
Jolanta Ewa Bilinska, Head of Dept. Int. Cooperation health Fund
Lodz, International Alliance of Patients Organizations
• Mission and Vision of IAPO - how to empower patients
• The proper information for patients about clinical trials
• How to raise awareness about clinical trials
Special Feature 16:45hrs
Open Round Table Discussion to summarize the information
learned through out the 2 days conference to raise final
questions and comments.
Closing Remarks 17:10hrs
Jo Burmester, Director Global Operations PharmaSchool Ltd
17:30hrs Cocktail Reception
All attendees are welcome to join at the complimentary cocktail
reception. An extended opportunity to network and benchmark.
DAY 2
8.15 - 9.00
Registration/ check in with tea and coffee
Opening Remarks by Chair – Jo Burmester

5. OECT Summit 12th – 13th March 2014, Berlin, Germany
Two Days Conferencewww.kp-morgan.com / info@kp-morgan.com
Patient recruitment and retention offer major challenges to
the clinical researcher with potential for significant impact on
timelines, budgets, and ultimately the scientific integrity of the
trial itself. Many factors affect the recruitment of patients and
difficulty in finding suitable patients is driving the develop-
ment of many innovative methods for accessing new patient
groups. The rise of social media means that new technolo-
gies and changing strategies for communication can be used
to great effect to reach out to patients directly and through
special interest groups, and to communicate with patients
enrolled in clinical trials. How to maximise the benefit of this
approach and ensure our regulatory obligations are appropri-
ately met will be the subject of several sessions during the
summit. Conducting trials in developing countries is becom-
ing more common, because of the potential for large numbers
of treatment naive patients and the willingness of healthcare
staff to learn about clinical research and work with sponsors.
There are, of course, challenges with this approach and dur-
ing the conference there will be opportunities to discuss the
advantages and obstacles, and hear from colleagues working
in these areas. Feasibility studies conducted before a clinical
trial commences can identify risks associated with the trial in
terms of patient recruitment and retention. Also the increasing
emphasis of certain Regulatory Agencies on Risk Assessment
and Risk Based Monitoring can serve to focus our attention on
identifying risks to patient recruitment and therefore develop
strategies to mitigate those risks. There will be sessions during
the summit looking at getting feasibility right, performing risk
assessment in a constructive way and considering the impact
of on-site monitoring on patient recruitment and retention
rates, and how to use this information in a risk based monitor-
ing setting.
A word from the chair
Jo Burmester, Director Global Operations PharmaSchool Ltd and Editor The Journal of
Clinical Research & GCP:
I am very pleased to be involved with this summit on an increasingly important area in
the conduct of clinical trials. The development of new medicines can only continue
if we can recruit patients to our trials and then keep them on board. In my time in the
industry, working with pharmaceutical and biotechnology companies, CROs and non-
commercial researchers, I have seen a dramatic rise in the regulation of clinical trials
and also in public awareness of the advantages and risks of taking part in research as
a patient. These changes offer challenges and opportunities which I look forward to
exploring during the summit.
Conference Benefits:
Opportunity to meet top expert and decision makers from Pharma, Biotech and CRO
industry under one roof.
Venue Berlin
A rewarding opportunity to visit Berlin, Germany
Berlin is a world city of culture, politics, media,
and science. Its economy is primarily based
on high-tech industries and the service sector,
encompassing a diverse range of creative
industries, research facilities, media corporations,
and convention venues. Berlin also serves
as a continental hub for air and rail transport
and is a popular tourist destination. Significant
industries include IT, pharmaceuticals, biomedical
engineering, biotechnology, electronics, traffic
engineering, and renewable energy. Berlin is
home to renowned universities, research institutes,
orchestras, museums, and celebrities and is host
to many sporting events.
Overview

6. Two Days Conferencewww.kp-morgan.com / info@kp-morgan.com
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OECT Summit, Berlin, Germany
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