The competitive post-marketing environment comes with a new set of challenges for clinical research. Your investigators are also your prescribers (your customers). It is essential for physicians to have a positive experience in your post-marketing research to maintain a good relationship. Keeping activities streamlined and focused – along with a risk-based operational solution – are keys to success of post-marketing research.
This presentation will cover:
- Proactive planning techniques to assess what matters most for your study
- Global reach with local knowledge/expertise
- Innovative operational approach to support prescribers
- Transformative technology to support clean and complete data
- Risk evaluation and mitigation strategies
In our presentation, we will present case studies that demonstrate successful implementation of these points. We will include the opportunity for you to ask questions as you envision how these techniques may apply to your strategy.
Too often, service providers lack the vision and the experience to operate in a mode other than pre-registration clinical trials. Join this webinar to get the tools you need to enhance the experience for your prescribers.
Dorothea Kimmel,
Senior Director of Operations, EU
Ms Kimmel heads our Late Phase Operations in Europe and Asia Pacific where she provides strategic input, functional oversight and operational leadership to PRA's late phase projects teams. Her role includes the operational implementation of late phase projects that require a central site management strategy and aligning the operational structure of projects with the planned strategy from the client. Ms Kimmel has over 26 years of experience in various roles within the CRO industry. She has gained broad experience not only in late phase services but also in clinical operations, project management, quality assurance, and proposal development, and has held various management positions. In her role in LPS, she has overseen projects varying in size and locations (from global programs in 5 continents and 49 countries with more than 30,000 patients to single country projects in rare diseases) across multiple indications.
Kim Maguire-Wright,
Senior Director of Operations, NA
Ms. Maguire-Wright is responsible for operations for the North American team. With over 20 years of experience in clinical research, Ms. Maguire-Wright has extensive knowledge of a variety of therapeutic areas in Phase IIIb, Phase IV, late phase, clinical diagnostic, and risk management programs. She has been responsible for designing and delivering several programs which meet FDA and EMEA mandates for post approval regulatory commitments for risk assessment and risk minimization, including drug registries and assessment programs being conducted to support components of product REMS, performance-linked access systems and pregnancy exposure registries. In her position prior to joining PRA, Ms. Maguire-Wright served as the Director of Epidemiology and Risk Management at a CRO where she was responsible for the oversight of REMS development and implementation programs, including the operations of over 35 REMS assessment survey programs. Ms. Maguire-Wright received her B.S. in Biology from Fairfield University and completed post graduate work in microbiology at University of Arizona.
- Common challenges and solutions in executing post-marketing research.
- Strategies that support active physician engagement in post-marketing research.
- Develop a cost-effective approach to execution that optimizes your return on investment (ROI).
- Create a feedback mechanism to analyze the success of your program.
- Pharma/Biotech (Dir/Mgr) – Research & Development
- Medical Affairs
- Post-Marketing
- Pharmacovigilance
- Health Outcomes
- Clinical Operations
