Clinical Study Design Preparation
Consulting and Regulatory Support
Medical Writing
Drug Safety and Pharmacovigilance
Project Management and Monitoring
Data Management and Biostatistics
Marketing Authorization
GMP Inspection Support
Clinical Supply Services and Logistics
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Full-Service
CRO Offerings

OCT offers a full range of clinical trial services for Phase I-IV and BE studies, including study design, regulatory support, site management and more.

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Full-Service Expertise

We provide a full range of high-quality clinical trial services for Phase I-IV and BE studies. We are engaged in projects at every stage – from clinical development strategy and study design preparation, to site management and patient engagement, to data management and biostatistics. We offer both full-service clinical study engagements and standalone services.

Customer-Oriented

Among our top priorities are the clinical development needs of our customers. To that end, our clinical operations team will keep looking for the best solutions to accommodate your project’s goals.

Accessible Support

The OCT team is always easy to reach. We provide initial trial strategy and design consulting, regulatory support and regular updates on your trial’s progress. We are ready to deliver high flexibility when resolving any issues, and are only a phone call or an email away.

Time And Budget Conscious

Our golden rule is to adhere to the plan in place. We do everything in our power to deliver on time and within your allotted budget.

Full-Service Clinical Research Projects

OCT has extensive experience in conducting first-in-human clinical trials in Russia, Central and Eastern Europe, both in healthy volunteers and patients (depending on the requirements of study design or ethical/regulatory authorities). In the countries of our operation OCT collaborates with the leading early stage research centers in order to assure fast enrollment of subjects.

When choosing a region for conducting pivotal clinical trials, sponsors often turn to countries in Central and Eastern Europe (CEE). This region is not only appealing in terms of access to many patients, but also provides access to a vast market.

Our in-depth experience with 300 projects in a great number of therapeutic areas, and access to a network of principal investigators at more than 1600 medical sites give us absolute confidence both in the quality of data derived from the clinical trials we conduct, as well as in our ability to meet demanding recruitment timelines.

OCT has conducted more than 25 post-authorization clinical trials. Central and Eastern Europe is one of the key regions engaged in such trials. Post-approval studies are divided into two groups: clinical (interventional) trials and pharmacoepidemiology (non-interventional/ observational) studies.

In interventional studies (always prospective), a drug is used in accordance with the registered indication, however, the examination and treatment scheme is determined by the study protocol and can differ from standard practice.

In non-interventional studies, patients receive a drug, device or procedure as a routine treatment, in accordance with the Summary of Product Characteristics and without any special procedures, i.e. without prescribing treatments or tests. Upon obtaining the new data, observational studies may lead to the planning and initiation of additional clinical trials with the purpose of new data registration.

Individual Clinical Development Services

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