For many medical device and pharmaceutical companies, outsourcing some or all aspects of their clinical study support is becoming more common. After years of product development, the clinical study is the last step in getting the product to the market and/or the most expensive phase of the product development life cycle. Choosing a CRO partner for your clinical study could make your clinical research work a resounding success, if done correctly, or a colossal failure, if not done well. From the CRO perspective, collaborating with the right (or wrong) sponsor companies will have an impact on your company’s success and your potential for future growth.
This session will focus on the keys to finding a good sponsor/CRO match for your clinical research. We will discuss ways to manage the work to ensure that the clinical study is completed as effectively as possible. Collaboration logistics such as who’s SOPs to follow and what to include (or intentionally exclude) in the contract will be discussed. In addition, ways to ensure effective communication will be presented from both the sponsor and the CRO perspective. Real world examples of CRO and sponsor collaborations will be provided.
This will be an interactive session. Throughout the discussion, the audience members are encouraged to provide input based on their experience with sponsor/CRO relationships as it relates to CRO selection, managing compliance, maintaining a strong relationship and managing the unexpected occurrences in the trial.
Key Learning Objectives
After this presentation, the attendees should have an understanding of:
- The sponsor and CRO perspectives of what it is like to collaborate with one another on a clinical research project
- The roles and responsibilities of a sponsor and a CRO in clinical research
- The keys to choosing the right CRO for clinical study support
- How to manage the logistics, such as elements of the contract, whose SOPs to follow, the regulatory document format and, most importantly, communication between the sponsor and CRO
Cassie Jacobson, Clinical Research Strategy Director, 3M, Critical & Chronic Care Solutions Division
Cassie Jacobson is currently the Clinical Research Strategy Director in 3M’s Critical & Chronic Care Solutions Division. She currently has responsibility for developing the global clinical strategy across 4 businesses. Cassie has been with 3M for 18 years conducting clinical and health economic studies across multiple businesses within healthcare. She also provides clinical research and health economic training for our global colleagues in all regions of the world.
Cassie is a graduate of the University of San Diego with a BA in Biology and Marine Science, a graduate of Humboldt State University with an MA in Biology, and has been a Certified Clinical Research Associate since 1999.
Katie Schaaf, Director, Strategic Partnerships, NAMSA
Katie Schaaf is the Director of Strategic Partnerships at NAMSA. Katie oversees the operations and manages the relationships for NAMSA’s clients that have long-term clinical and consulting needs across multiple projects with NAMSA. In her 15+ years in the medical device industry, Katie has supported and managed all phases of clinical research, including many IDE feasibility, pivotal and post-approval studies. Katie has developed, organized, administered and conducted training sessions and seminars on several topics, including Clinical 101 (full day and half day) both externally and internally to non-clinical colleagues and has been a guest lecturer at St. Cloud State University (Masters in Clinical Research program) and St. Catherine’s University (Doctorate of Nursing program).
Katie holds a M.S degree in biostatistics from the University of Minnesota and a B.S. in mathematics from the University of Wisconsin – River Falls.
Who Should Attend?
- Clinical Trial Teams
- Clinical Operations
- Clinical Project Management
- Monitoring Managers
- Clinical Management
- Procurement Teams
- Heads of R&D
- Regulatory Affairs
- Outsourcing Executives
- Sponsor and CRO Employees
NAMSA is a Medical Research Organization (MRO), accelerating product development through integrated laboratory, clinical and consulting services. Driven by our regulatory expertise, NAMSA’s MRO® Approach plays an important role in translational research, applying a unique combination of disciplines—consulting, preclinical, toxicology, microbiology, chemistry, clinical and quality—to move client’s products through the development process, and continue to provide support through commercialization to post-market requirements, anywhere in the world.