oct clinical trials in central and eastern europe

Pursuit of excellence,results and knowledgein clinical research!

OCT provides Phase I-IV clinical trials

to pharmaceutical, biotechnology and

medtech companies. OCT works in

accordance with local,

FDA and EMEA requirements.

OCT ensures GCP-compliant

clinical trials.

OCT collaborates mostly with

medium-sized and small-sized

companies from the EU, USA, Israel,

Russia, China and other countries. OCT

works with the top ten Pharma and upper

CROs, as well. Currently, we have

around 90 specialists on staff in all OCT

offices.

What range of services OCT provides• Medical writing and consulting• Regional and global project management• Site selection and management• Regulatory/EC affairs and local insurance• Clinical monitoring• Clinical trial materials and supply management • Audits and quality assurance

• Data managementand statistical analysis • Safety management• Investigator meetings • Feasibility analysis • GCP trainings• Vendor/services provider management: — Central laboratory — Central imaging

— Warehouse — QP releaseOCT performs all types of trials:• Early stage trials• Pivotal trials• PK/BE trials • Post-marketing studies• Pre-clinical research

OCT is a regional full-service CRO operating in Central and Eastern Europe (CEE), including Russia, Ukraine, the Baltic States (Latvia, Lithuania, and Estonia), Belarus, and Bulgaria.

Professionalteam

Jointexperience

High-qualityservice

Competitivepricing$

Professionalteam

Jointexperience

Competitivepricing$

• High quality clinical data thanks to GCP experienced investigators in the region, the emphasis on thoroughly organized project management and site selection, medical education of CRAs and PMs

• High speed patient enrollment due to the prior careful site selection based on established relations with sites across all OCT countries and professional work of the feasibility team

• Commitment to timelines through implementation of effective risk management tools

• Reliability proven by more than 5-year operations and working with leading biotechnology, pharmaceutical companies and life science institutional investors, positive Sponsor’s audit reports

• Flexibility and client-oriented approach aimed to achieve our Partners’ special needs, work in one team with our Clients

• Accuracy resulted in high quality clinical data, precise feasibility analysis, and compliance to budgeted timelines and costs

• High degree of ethical standards both in clinical and business activities

• Competitive and flexible pricing through comparatively low hourly rates and PI grants in the CEE region, discounts to regular buyers, openness to negotiations

• Risk management through local expertise, established close effective relations with key opinion leaders and ability to receive their expertise, good relations with regulatory authorities, scenario approach

• Pro-activity and fast response in communication with our Clients as a corporate gold standard

• Regular and transparent reporting to our Clients, readiness to report in a Client`s format

• Flexible vendors’ outsourcing, which provides options to our Clients

• Development of international partnership with other CROs, vendors, professional organizations

• A growing company due to the low turnover rate, developing new services, continuous staff recruitment, entering of new countries, repeat business, and new clients

• Audit readiness 24/7.

How OCT differentiates ourselvesOCT advantages are:

We position ourselves as a medium-sized full-service CRO with local expertise in CEE countries, on the one hand, and possibility to provide global project management within international multicenter clinical trials, on the other hand. OCT does its best to establish close working relations with its Clients and standardized practices essential for producing consistent excellence in clinical trials outsourcing.

OCT works in all therapeutic areas. However, one third of OCT experience is in oncology due to the high potential of the region in terms of patients enrollment. We have developed long-term and successful collaborations with the leading oncology centers in the region. Please read one of OCT case studies in oncology below.

OCT has performed a Phase III EMEA and FDA-controlled study in neutropenia induced by polychemotherapy of breast cancer. The trial was

placed in Russia, Latvia, Bulgaria, and other European countries. The target number of randomized patients equalled to 279 globally. The investigational drug was a G-CSF. OCT has enrolled 184 patients at 12 sites within 9 months. Within the study, OCT provided project management and administration, regulatory and logistics support, clinical monitoring, CRA training, audits, purchase of concomitant medication, other services. As a result, the clinical data have been applied to the authorities and the drug has been registered in the EU and the USA.

Experience

OCT have solid experience in: • Endocrinology• Cardiology• CNS• Urology and Nephrology

• Infectious diseases• Pediatrics• Rheumatology• Respiratory

• Gastroenterology• Nutrition

Most of the trials are Phase II (32% of projects) and Phase III (30%). OCT also have reasonable experience in Phase I and BE/PK (20%) and Phase IV studies (12%), for example, post-marketing research projects for the leading international company, which is in the top ten pharmaceutical distributors in Russia.

OCT performs early and late stageclinical trials

6.7BE / PK

%2.3Medical device

13.5Phase I

31.5Phase II

%30.3Phase III

11.2Phase IV

4.5Pre-clinical