CLINICAL TRIALS SITE MANAGEMENT

This highly-interactive event in the Clinical Trials in Canada series brings together institutions, regulators and industry representatives to discuss current challenges of globalization and potential solutions for greater efficiency at the clinical research site level. Specifically, presentations will provide practical strategies on how we can improve processes to be more competitive in a global market.

Presentation highlights include:

• Health Canada’s perspective on the future of Canadian clinical research
• Industry panel discussion on how BRIC countries are impacting our competitiveness and suggested areas for improvement
• Sponsor/CRO/Site panel recommendations on how to optimize investigator/site selection and recruitment
• An update on national initiatives for REB review in Canada
• Patient recruitment strategies when struggling with negative press and reluctant patients
• The impact of multi-centre clinical trials and globalization on CTAs
• Hear what the top 5 issues are that delay and derail contract negotiations and how to overcome them
• How to improve site monitoring and deal with site management of unanticipated events
• How to prepare for Health Canada and FDA Inspection with an eye-opening look at FDA findings

PROGRAM CO-CHAIRS

Pierre Gervais, B. Pharm., M.Sc.
President, Research Director
Q&T Research – Sherbrooke
Research Director
Q&T Research – Outaouais

Kim McDonald-Taylor, M.Sc.
President
Clinical Research Association of Canada (CRAC)
Director of Clinical Services
Wyatt Health Management

KEYNOTE ADDRESS

The Future of Clinical Trials in Canada: A Health Canada Perspective

Agnes Klein, MD, DPH
Director, Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products
Biologics and Genetic Therapies Directorate (BGTD), Health Canada

Accreditation of this training activity by the Barreau du Québec as
Mandatory Continuing Legal Education is pending.

SPONSORS

Industry representatives (sponsor and CRO), clinical investigators, study coordinators, contracts negotiators (hospitals and law firms), hospital research administrators, civil servants involved in provincial initiatives to encourage clinical research, and federal and provincial regulatory agencies from pharma, biotechnology and medical devices including:

• Chief Medical Officers and Medical Directors
• Heads of Medical Affairs and Clinical Research
• Heads, Directors and Managers of Clinical Operations
• Heads, Directors and Managers of Clinical Research
• Directors or VPs, Scientific Affairs/Government Relations
• Research Ethics Board Members
• Clinical Researchers
• Clinical Study coordinators and Study Nurses
• Clinical Project Leaders and Research Associates
• Clinical/Site Monitors and Auditors
• Regulatory Managers and Clinical Investigators

• Heads of Quality Control/Assurance/Compliance/Ethics
• Clinical Statisticians
• Clinical Data Managers/Co-ordinators
• Health Canada, Senior Advisors, Researchers and Policy Developers
• Health, Pharma, Medical Device and Biotech Lawyers
• Health, Pharma, Medical Device and Biotech Trade Association Representatives
• Clinical Trial Consultants and Service Providers
• Insurers/Defence Providers
• Heads of agencies that Fund Research, including Governments, Research Charities, and Medical Research Councils

Dear Colleague,

We are delighted to invite you to the 8th Edition of Insight Information CLINICAL TRIALS SITE MANAGEMENT to take place in Montreal this year.

A solid board of experts will share their perspective about Improving Processes and Achieving Greater Efficiencies in a Global Market in the context of increasing globalization of clinical research, strong presence of BRIC countries, tighter timelines, complex technologies, negative press and reluctant patients. Practical solutions will be offered to help you improve processes at your sites.

The keynote presentation, The Future of Clinical Trials in Canada: A Health Canada Perspective, will address the concerns of many Canadian stakeholders and will initiate two days of challenging and fruitful discussions.

We look forward to seeing you in Montreal, November 30 and December 1st.

Pierre Gervais, B. Pharm., M.Sc.
President, Research Director
Q&T Research – Sherbrooke
Research Director
Q&T Research – Outaouais

Kim McDonald-Taylor, M.Sc.
President
Clinical Research Association of Canada (CRAC)
Director of Clinical Services
Wyatt Health Management

Monday | November 30, 2009

8:00 | 9:00

Registration & Continental Breakfast

9:00 | 9:10

Welcome and Opening Remarks from the Co-Chair

Pierre Gervais, B. Pharm., M.Sc.
President, Research Director
Q&T Research – Sherbrooke
Research Director
Q&T Research – Outaouais

9:10 | 10:00

The Future of Clinical Trials in Canada: A Health Canada Perspective

Agnes V. Klein, MD, DPH
Director
Centre for the Evaluation of Radiopharmaceuticals and Biotherapeutic Products
Biologics and Genetic Therapies Directorate (BGTD)
Health Canada

In order to provide a look into the future of Clinical Trials in Canada, there is a need to examine the past, the present, new regulatory endeavours and briefly touch on regulatory reform from the perspective of the analysis of the clinical trials regulations currently in place.

There is also a need to bring into this vision of the future, the ethics environment, public demands and the environment in other developed and developing countries.

Finally, the picture would not be complete without factoring in these considerations:

• The real strengths and the innovative science that Health Canada has to offer
• The clinical trials establishment; well-known for the high quality studies that are carried out in Canada
• Notably, the NCIC and the HIV Trials Network; highly sought after networks that have been used as examples to follow for the quality of science and the treatment of patients

The concern will remain, however, that there may be a significant migration of studies to other jurisdictions where the costs are lower, but where the ethnic mix of the population does not reflect the Canadian reality.

Finally, advances in science and the advent of genomics will factor into the big picture.

This talk will provide an overview and some analysis of all factors noted above that contribute to the success of the clinical trials enterprise in Canada.

10:00 | 10:15

Networking Coffee Break

10:15 | 11:00

National Initiatives and Innovation in REB Review in Canada

Ron Heslegrave Ph.D.
Chair, Research Ethics Board
University Health Network
Ontario Cancer Research Ethics Board

There is a movement towards centralized research ethics review in Canada. Recently CMAJ talked about ‘doing it once and doing it right’. This session will provide a perspective on some of the initiatives taking place on both a provincial and national level. In the industry panel to follow, industry will also comment on these new initiatives – will they work or won’t they?

11:00 | 12:15

Clinical Trials in Canada: How Competitive Are We?

Lesley Barnett, B.Sc. (Hons.)
Director, Clinical Development
GlaxoSmithKline Inc., Canada

Sandra Gazel, M.Sc.
Associate Director, Clinical Operations, Medical Division
Abbott Canada

Marc Veronneau, M.Sc.
Associate Director
Wyeth Research

This panel will discuss some of the significant challenges currently facing Canadian clinical research, including:

• Can we compete with BRIC countries (Brazil, Russia, India, China and South Africa)?
• Where are the projects being allocated and what are the deciding factors?
• What are some other areas we can be competitive in?
• What else can we do if it’s not recruiting patients and managing sites?

12:15 | 1:30

Networking Luncheon

1:30 | 2:30

Optimizing Investigator/Site Selection and Recruitment

Sponsor/CRO Perspective: What We Are Looking For?

Maryse Simard
Associate Director, Study Start-up
Quintiles Canada Inc.

Jean-Marc Tellier., M.Sc.
Medical Advisor
Sanofi-aventis Canada

• Which sites are first identified?
• What about site performance?

Site perspective: What We Need to Do to Maintain Motivation at the Site and Improve Investigator Recruitment Success

Pierre Gervais, B. Pharm., M.Sc.
President, Research Director
Q&T Research – Sherbrooke
Research Director
Q&T Research – Outaouais

Other Panelists To Be Confirmed

2:30 | 3:15

Monitoring Site Visits: Improving the Process

Sophie Boudreau, B.Pharm., D.S.A.
President, Independent CRA
GEM Clinical Research Inc.

In the context of study globalization, Clinical Research Monitors must be able to manage multiple tasks to fulfill their role, from selecting sites, training sites for initiation visits, perform routine monitoring and close out activities. These tasks are becoming more and more complex. There are multiple regulations and guidelines that a monitor needs to be aware of to remain successful in fulfilling this role. This talk will focus on the following topics:

• The complexity of monitoring
• The current challenges of monitoring
• A proposed holistic approach
• Strategies to increase efficiency in monitoring

3:15 | 3:30

Networking Refreshment Break

3:30 | 4:15

Patient Recruitment Strategies: How to Overcome Negative Public Perception

Karine Côté, BBA, RN
Associate Director
Operations and Recruitment

Pierre Gervais, B. Pharm., M.Sc.
President, Research Director
Q&T Research – Sherbrooke
Research Director
Q&T Research – Outaouais

Q & T Research is an independent clinical research site working exclusively in Phase II-III clinical research. Q&T was involved in more than 100 trials in the last 10 years and has recently implemented its own recruitment center with locally targeted recruitment strategies. This presentation will discuss root cause analysis for low recruitment, strategies to address these challenges, implementation of solutions and grid results.

• Recruitment reality for a research center
• Perception of general and specialized public groups
• Segmentation and positioning strategies
• Patient recruitment strategies
• Results and measures of recruitment campaigns

4:15 | 5:00

Site Management of Unanticipated Events – A Participant-Centric Approach

Janice E. Parente, Ph.D.
President/Managing Director
ethica Clinical Research Inc.

• What constitutes an unanticipated event?
• Who needs to be notified and when?
• What information should be disclosed?
• What needs to be done to mitigate the risk of harm to research participants and who assumes the costs?
• What are the rights of the research participant in the management of unanticipated events?
• The benefits of having SOPs

5:00

Conference Adjourns for the Day

Tuesday | December 1, 2009

8:00 | 9:00

Continental Breakfast

9:00 | 9:10

Opening Remarks from the Co-Chair

Kim McDonald-Taylor, M.Sc.
President
Clinical Research Association of Canada (CRAC)
Director of Clinical Services
Wyatt Health Management

9:10 | 10:15

Top 10 Do’s and Don’ts for Clinical Research Sites and Sponsors

Ann-Merie O'Halloran, PhD
Manager, Clinical Capabilities and Compliance
Novartis Pharmaceuticals Canada Inc.

Brenda Nolf, RN, MSc, CCRA
Senior Clinical Research Associate
Schering-Plough Canada Inc.

Julie Gibson, MA, CCRC
Director, Clinical Research Services
Research Institute
The Hospital for Sick Children

10:15 | 10:30

Networking Coffee Break

10:30 | 11:15

Managing Site Clinical Trial Agreements (CTAs)

Michelle Moldofsky, LLB, LLM
Policy & Legal Advisor, Office of Research Administration
St. Michael’s Hospital

• The impact of multi-centre clinical trials and globalization on CTAs
• Negotiating strategies for dealing with multiple sites
• Top 5 issues that delay and derail contract negotiations

11:15 | 12:15

Standard Operating Procedures (SOPs)

Moderator: Kim McDonald-Taylor, M.Sc.
President
Clinical Research Association of Canada (CRAC)
Director of Clinical Services
Wyatt Health Management

Karen Arts
Director, Business Development
Ontario Institute for Cancer Research

John Akitt
President and Co-founder
Trial Management Group

• Why have SOPs
• Common misunderstandings
• Development of a national set

12:15 | 1:30

Networking Luncheon

1:30 | 2:15

Good Clinical Practice: Meeting Expectations

Karen Arts
Director, Business Development
Ontario Institute for Cancer Research

How can we develop a common approach?

• A national clinical research education program
• A national set of SOPs
• Reciprocity

2:15 | 3:00

Health Canada & FDA Audits: What Experience Has Taught Us

Kim McDonald-Taylor, M.Sc.
President
Clinical Research Association of Canada (CRAC)
Director of Clinical Services
Wyatt Health Management

This presentation will look at the differences between Canadian and US Government inspections and will explain how to prepare for an audit. You will also hear case study examples of audits plus a review of some FDA Inspection letters listing the findings
– quite eye opening!

3:00 | 3:15

Networking Refreshment Break

3:15 | 4:00

Contract/Budget Management: An Institutional Site Perspective

Marie-Luce Fortier, LL.L, LL.B
Lawyer
Senior Manager, Development of Contractual Research
Centre de recherche du Centre hospitalier de l’Université de Montréal (CRCHUM)

• How can we speed up the contract negotiation process?
• What should institutional sites look at when they review trial budgets?

4:00 | 4:45

From Protocol Feasibility to Reimbursement: Can We Do This?

John Akitt
President and Co-founder
Trial Management Group

This presentation will focus on the determining factors to decide if the study is feasible, including:

• Patient availability
• Workload
• Budget for procedures
• Budget for advertisement
• Timelines

It is not just signing up – but being successful that counts.

This talk will help you to concentrate on what really matters in a feasibility exercise.

4:45

Register 3 delegates for the main conference at regular price at the same time and you’re entitled to register a fourth person from your organization at no charge. For other group discounts, please call 1-888-777-1707. All discounts must be redeemed when booking, discounts will not be valid or applied after this time.