Medpace is a global full-service Clinical Research Organization (CRO) providing comprehensive development services for drug, biologic, and device programs. Medpace is at the forefront in working with to sponsors bringing life-saving and life-enhancing cell therapies and regenerative medicines to market.
The complexity of developing regenerative medicine products requires a committed and experienced partner. Our work with innovators, regulators, key opinion leaders and investigators in this area gives us unique insight into the challenges and hurdles to be overcome as we shepherd our client’s product through the development process. Here are a few key points to consider about Medpace’s capabilities in this area:
- Design, plan and manage studies that proactively address the operational complexities inherent to the development of these novel therapies
- Successfully navigate global regulations unique to cell therapies and regenerative medicine
- Integrate imaging and central labs for cohesive, streamlined and standardized trial management
The Medpace Difference for Regenerative Medicine Studies
- Experienced in cell therapy studies including key therapeutic areas such as cardiovascular, neuroscience, hematology, musculoskeletal, diabetes, and wound care.
- Regulatory experts with in depth knowledge of the latest global regulations related to regenerative medicine products, including Europe’s Advanced Therapy Medicinal Products (ATMP) guidance.
- Network of trained investigators with the capabilities and experience to store, prepare and administer these unique products.
- Central laboratories with specialized product storage and delivery capabilities.
- Medpace Medical Device – a wholly-owned subsidiary – is exclusively dedicated to designing and conducting medical device trials.
To learn more, visit the Medpace web site at www.medpace.com.
Contact Medpace, Inc.