Case Study

NAVIGATING THE USE OF CONTROLLED SUBSTANCES IN CLINICAL TRIALS USING IRT: Understanding DEA Form 222

NAVIGATING THE USE OF CONTROLLED SUBSTANCES IN CLINICAL TRIALS USING IRT: Understanding DEA Form 222

Pages 3 Pages

NAVIGATING THE USE OF CONTROLLED SUBSTANCES IN CLINICAL TRIALS USING IRT: Understanding DEA Form 222Taking a Consultative Approach on the Road to Controlled Substances in Clinical Trials Clinical trials that use controlled substances are generating promising results for a large number of indications, including treatment-resistant depression and epilepsy. Sponsor organizations that want to use controlled substances in clinical studies must manage the associated regulatory and logistical requirements. This can be challenging for Emerging BioPharmas with Trial design incorporating a controlled substance is a highly specific, complicated process that can take weeks or much longer. Our team’s proven framework enables us to anticipate and design for change, and create the specific

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