We've merged with Palleos Healthcare to form a wide-reaching European CRO.
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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, click here.
OCT Clinical is now operating under Palleos Healthcare brand name.
“The merger will undoubtedly create significant synergies, not just doubling but squaring the expertise of both companies”, Philip Räth, Ph.D., managing director at Palleos, said in the release.
“OCT Clinical is proud to join forces with palleos healthcare, as it has an excellent reputation in the industry it serves. Now we can offer tailored solutions to our clients to meet their diverse clinical research needs and accelerate the time of bringing their products to market”, Dmitry Sharov, CEO at OCT Clinical.
