Cmc

What if you could start the next clinical development stage sooner, significantly saving the study time and costs and providing more flexibility?

PRA’s Accelerated Early Clinical Manufacturing services provide on-site IMP development and manufacturing, as well as in-house Quality Control lab testing—all in accordance with GMP. This allows our sponsors to start the next clinical development stage sooner, significantly saving the study time and costs, and providing more flexibility.

API-to-IMP cohort cycles

Api to imp

The state-of-the-art GMP facility allows us to receive the API and manufacture it into an IMP, released by QP/QA, and distribute to trial sites in accordance with GCP to meet study objectives.

First GMP-Compliant IMP Manufacturing in the US

With our in-house Chemistry Manufacturing Control (CMC) capabilities, PRA has been manufacturing Investigative Medicinal Products (IMP) for early drug development for over 15 years. Now, we are excited to expand this service to our US-based clinic in accordance with the EU Good Manufacturing Practice (GMP) standards.

Download Accelerated Early Clinical Manufacturing Whitepaper
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Flexibility and Speed

• AECM makes it easier for clinicians to get the most accurate data out of their study because of our capability to manufacture the dose “on demand” for the sponsor during the clinical trial

• Only short-term stability data of the intended dose range is required

• Flexibility in adjusting the dose strengths prior to or during the clinical conduct

• Development of a complicated formulation with extensive stability data is not required

• Development of a formulation to meet the objectives of the early clinical phases

• Integrated CMC services, including QP/QA-release, are available and support a quick distribution route to the clinical sites

• Fast turnaround of the clinical data

Take a video tour of our Accelerated Early Clinical Manufacturing

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