Stay current on the ever-changing pharmaceutical regulatory environment with 10 audio recordings of industry experts offering practical guidance on conducting clinical trials.
Ovid and FXConferences offer thousands of professional development hours for your teams, conveniently packaged and delivered as a collection of audio recordings to save you time and money.
Topics in this collection have a global appeal and are relevant for multiple departments within your organization—R & D, Market Research, Compliance, and more. Each of the 10 recordings consists of a 45-minute, telephone-based presentation delivered by expert international speakers, followed by a 15-minute question-and-answer session (collection available with and without transcripts).
1. Centralized vs Onsite Monitoring – Applying FDA's Risk-based Approach
Speaker: Sandra Maddock, President & CEO, IMARC Research, Inc.
2. Implementing the FDA Guidance on Investigator Responsibility
Speaker: Lorry Witte, RN, BA, CCRC, CCRA, Clinical Research Consultant
3. Clinical Study Reports 101: Writing the Synopsis
Speaker: Dr. Susan Sisk, Principal, SFP Consulting
4. Improving Study Feasibility- Why Sites Fail and How to Avoid It
Speaker: Nikki Christison, President, Clinical Resolutions
5. Patient Recruitment: How It's Broken and Five Ways to Fix It
Speaker: Sherry Reuter, President, Sherry Reuter & Associates
6. Writing Clinical Data Queries – Best Practices and Pitfalls
Speaker: Rick Brogden, Clinical Data Analyst, INC Research
7. Site Visit Follow-up – Letters, Notes to File and CAPA Plans
Speaker: Amy Adams, Clinical Project Manager, SAIC-Frederick, Inc.
8. Best Practices for Source Documentation and Verification
Speaker: Tammi Masters, Senior Clinical Trainer, INC Research
9. Budget Development Considerations for Clinical Research Sites
Speaker: Katherine Hammerhofer, Finance Director, Center for Clinical Research & Technology for University Hospitals Case Medical Cente
10. Conducting Clinical Trials in China – What Does SFDA Want?
Speaker: Seth J. Goldenberg, President, Asia Pacific Bio Intelligence