[Industry Voice #20] Roche Pharma on…
Case Study: How to enroll 612 patients…
OCT Clinical, a European CRO, has initiated a bioequivalence study in partnership with a Germany-based pharmaceutical company, one of the leading pharmaceutical companies in Central and Eastern Europe.
This is a prospective, randomized, open label, multiple dose, two treatment, two period, two-sequence, two-way crossover bioequivalence study versus the reference drug in healthy adult male subjects, under fed conditions and at steady state.
The duration of the therapy is 18 days, and the total duration from the screening period to the end of the study for each patient will take up to 47 days. As of now, 48 healthy male subjects have been screened and 40 have been randomized.
The next important milestone is to receive approval to conduct the study after provision of all clinical trial related documents requested for the submission.
Within this project, OCT Clinical is responsible for a wide scope of clinical trial services, including regulatory support, project management, monitoring, medical writing and logistics. For more information on OCT Clinical’s CRO services, visit www.oct-clinicaltrials.com/services.