Regenerative Medicine

In the last 3 years, Integrium has conducted over a dozen high profile, Regenerative Medicine/Gene Therapy Clinical Trials. As a result, we have developed the logistical and scientific experience that reliably provides solutions to the inevitable challenges accompanying this niche-type drug development. With Integrium's Regenerative Medicine expertise, our dedicated team can design, manage, and produce rapid results for a clinical trial, given the intricacies of developing such innovative therapies.

Integrium offers our clients:

  • Expertise in navigating the regulations linked to regenerative medicine products
  • Rationale for your Proof of Concept cell/gene therapy trials
  • Recommendations for protocol development and later clinical trial design
  • Development programs that include initial safe starting dose, dose escalation scheme, target organ/tissue toxicity, eligibility criteria, clinical monitoring
  • A network of Local IRBs / Safety Review Boards / Recruitment / Staff Training
  • Medical Experts in the cardiovascular and neuroscience space
  • An unparalleled patient recruitment team

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