8th Edition Clinical Trials Site Management

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SKU: PHP09442 Category:

Description

Report Code: PHP09442. November, 2009. Montréal, QC

ARTICLE I

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

Agnes V. Klein, MD
Biologics and Genetic Therapies Directorate
Health Canada

ARTICLE II

National Initiatives in Ethics Oversight in Canada

Ronald J. Heslegrave, PhD
University Health Network, Mount Sinai Hospital and Ontario Cancer Research Ethics Board
Chair
Research Ethics Board

ARTICLE III

Optimizing Investigator/Site Selection and Recruitment
Sponsor Perspective: What We Are Looking For?

Jean-Marc Tellier
Medical Advisor, Clinical Research Unit
Sanofi-aventis Canada

ARTICLE IV

What Does a Site Need to Maintain Motivation and Improve Recruitment

Pierre Gervais, B.Pharm., M.Sc.
Director, Business Development (Q&T Research Outaouais);
Director, Business Development (Q&T Research Chicoutimi); President
Q&T Research – Sherbrooke

ARTICLE V

Monitoring Challenges

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

ARTICLE VI

Patient Recruitment: How to Overcome Negative Public Perception

Pierre Gervais, B.Pharm., M.Sc.
Director, Business Development (Q&T Research Outaouais);
Director, Business Development (Q&T Research Chicoutimi); President
Q&T Research – Sherbrooke

Karine Côté, BBA, RN
Associate Director, Operations and Recruitment
Q&T Research Inc.

ARTICLE VII

Managing Site Clinical Trial Agreements

Michelle Moldofsky, LLB, LLM
Policy and Legal Advisor
St. Michael’s Hospital

ARTICLE VIII

Standard Operation Procedures

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

John Akitt
President and Co-Founder
Trial Management Group, Inc

ARTICLE IX

The Network of Networks: A National Set of SOPs

Karen Arts
Director – Business Development
Ontario Institute for Cancer Research

ARTICLE X

Good Clinical Practice: Meeting Expectations

Karen Arts
Director – Business Development
Ontario Institute for Cancer Research

ARTICLE XI

Health Canada & FDA Audits: What Experience Has Taught Us

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

ARTICLE XII

Contract/Budget Management: An Institutional Site Perspective

Marie-Luce Fortier, LL.L., LL.B
Lawyer
Centre de recherche du Centre hospitalier de l’Université de Montréal (CRCHUM)

ARTICLE XIII

From Protocol Feasibility to Reimbursement: Can We Do This?

John Akitt
President and Co-founder
Trial Management Group, Inc.