Advanced Therapies

Advanced Therapies

Global Advanced Therapy Experience

Advanced Therapy Clinical ResearchMedpace has been a pioneer in the clinical development of Advanced Therapies and offers Sponsors an experienced team of experts who take an active role in the field and are at the forefront of rapidly changing clinical and regulatory developments.

Medpace has global Advanced Therapy experience across numerous therapeutic areas and global regions.  Areas of advanced therapy expertise and specialty include malignant and benign hematology, oncology, cardiovascular, diabetes, neuroscience, nephrology, wound care, rare disease and orphan indications, pediatrics and medical device.

Areas of Expertise Include:

  • Hematopoietic cell transplantation
  • Bone marrow transplantation
  • Gene therapy
  • Gene editing
  • Graft versus host disease
  • Cellular therapy
  • Tissue therapy
  • Adaptive immunotherapy
  • Tissue engineered products

The Medpace Difference for Advanced Therapy Studies

As an active CRO in this rapidly advancing area, Medpace offers numerous advantages:

  • Advanced therapy physicians partnering with over 30 Medpace sub-specialist medical doctors to advise, design and execute clinical trials
  • Experience in the planning and management of advanced therapy clinical trials with proactive solutions to the operational complexities inherent in these therapies
  • Regulatory experts with in-depth knowledge of the latest global regulations and developments related to advanced therapy products in all major regions, including FDA and EMA processes linked to advanced therapy clinical development pathways
  • Network of globally trained investigators with the capabilities and experience to store, prepare and administer these unique products
  • Active, long-term member of the Alliance for Regenerative Medicine, a Washington, D.C.-based non-profit organization whose mission is to educate key policy makers about the potential of regenerative medicine and to advocate for favorable public policies—funding, regulatory, reimbursement and others—to facilitate advances in the field
  • Integration with rare disease clinical team, including pediatrics
  • Central imaging for cohesive, streamlined and standardized trial management
  • Central laboratories with specialized product storage and delivery capabilities
  • Medpace Medical Device, exclusively dedicated to designing and conducting medical device trials