Clinical Trials
Leadership
Mission
Action Plan
- To locate and share industry and regulatory guidelines, journals, articles, references, standard operating procedures, and consultant resources for conducting clinical trials whether internally or with external clinical trials organizations.
- To serve as a resource for information about training programs for clinical research professionals in order to meet the growing needs of the industry.
- To identify and to provide a network of local mentors for professionals involved in clinical trials.
- Hosting presentations relating to current issues within clinical trials.
- To pinpoint areas that require guidelines to ensure consistency in carrying out clinical trials.
Topics
- The Common Technical Document
- EDC opportunities and limitations
- Sharing responsibilities with CROs
- Cardiac safety monitoring in clinical trials
- Electronic records
- Use of Quality of Life measures in clinical trials
- Legal issues relating to clinical trials
CURRENT TOPICS
- Development of Oncology Treatments
- Merger of HER/EDC
- Upfront Contingency Planning
- Adaptive trial design
- European Union Clinical Trials Directive
- European regulations on pharmacovigilance
Meetings
Past Presentations
| Date | Presentation |
|---|---|
| 3/14/08 | Mastering Partnerships with CROs |





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