The Integrated Summaries of Safety and Efficacy (ISS and ISE, respectively) represent the culmination of what may be a decade or more of work in clinical development. Even with proper planning, timely delivery of the integration is not always ensured, often due to reasons outside of one’s control. With the significant volume of work the integration requires plus the multiple inputs, there are myriad places for a breakdown to occur. This late in the clinical development lifecycle, any delay can have a significant impact on getting a drug approved and on the market.
In this free webinar, the featured speaker will discuss what happens when an integration goes off the rails and all that hard work and careful planning start to come apart. She will address types of issues one may face affecting the integration process and ways that one can react to them, and even more importantly, how one can proactively anticipate the issues and manage their impact. From failures with critical pivotal Phase III trials to time crunches and resource constraints, this webinar will delve into the tools necessary to keep the train on the track.
Nancy Fitzgerald, MS, MBA, Biostatistics Director, Synteract
Nancy Fitzgerald brings more than 21 years of experience in pharmaceutical, biologics and medical device research across all phases of development (Phase I-IV). Nancy has extensive experience in regulatory affairs including interactions with regulatory authorities, study development, clinical operations, data management, statistical analysis, quality and auditing across a broad range of therapeutic areas. She has served in executive management positions where she has managed programs resulting in 41 NDA, ANDA, PMA and 510k approvals.Message Presenter
Who Should Attend?
This webinar will appeal to VPs, Directors, Managers, Department Heads, Scientists and Researchers working within:
- Clinical Affairs
- Clinical R&D
- Clinical Research
- Clinical Pharmacology
- Clinical Operations
- Project Management
- Regulatory Affairs
- Medical Affairs
What You Will Learn
Attendees will learn about:
- Warning signs that ISS/ISE might not go according to plan
- Mitigation strategies to handle the issues when they arise
- Key considerations to manage when planning the work
With employees across 21 countries, Synteract is an innovative, full-service CRO supporting biopharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted 4,000 studies on six continents and in more than 60 countries, working with more than 26,000 investigative sites and 750,000 patients. Greater than 245 of its 4,000 studies have been in pediatric populations. In addition to pediatrics clinical trials, Synteract offers a notable depth of therapeutic expertise in dermatology, neurodegenerative, oncology and immunotherapy, and rare/orphan disease studies.