To start a clinical trial in Central and Eastern Europe it is highly advisable to have a local expert in this region. OCT is happy to provide regulatory support to our clients in CEE.
Regulatory requirements vary depending on the country study is being conducted in and the kind of drug being studied. OCT provides regulatory services in Russia, Ukraine, Latvia, Lithuania, Estonia and Bulgaria.
When big late phase trials include Central and Eastern Europe, careful selection of each country is made by Sponsor. The final selection is determined by several factors. The most important factors are the incidence of the specific therapeutic indication in each country, the rate of patient recruitment, quality of clinical sites and investigator availability, sites experience in the specific disease indication and the costs for conducting trials in regions outside of the areas usually chosen.
Sponsors are also very concerned with the shortness and complexity of study submissions to Ethics Committees and the Ministry of Health. Costs and timelines are always concerns for sponsors since they may greatly influence the schedule for trial conduct.
We recommend our clients if any CEE country are considered for a trial, to include these countries at the very beginning of the trial and not use these countries as rescue countries.
We have developed an excellent collaboration with national Regulatory Authorities and Ethics committees in the countries of our presence. OCT is dedicated to expediting the regulatory review process and shortening study timelines. With more than 6 years of successful regulatory experience startup timelines are completely predictable for OCT:
| Country |
process |
Study approval timelines, in months |
Total |
Comment |
||
|
RA |
CEC |
LEC and license if applicable |
||||
| Clinical trial approval in Russia | parallel | 2 | 2 | 1 | 3 | The information regarding the clinical trial is entered by OCT to the Ministry of Healthcare and Social Development electronic base before study submission |
| Clinical trial approval in Ukraine | parallel | 2 | 2 | 0,5 | 2,5 | Agreements between OCT-PIs and OCT-site should be signed before study approval |
| Clinical trial approval in Belarus | consecutive | 3 | N/A | 1 | 4 | No CEC in Belarus, studies are approved by LECs |
| Clinical trial approval in Latvia | parallel | 2 | 2 | N/A | 2 | No LECs |
| Clinical trial approval in Lithuania | parallel | 2 | 2 | N/A | 2 | No LECs |
| Clinical trial approval in Estonia | parallel | 2 | 2 | N/A | 2 | No LECs |
| Clinical trial approval in Bulgaria | parallel | 2 | 2 | 0,5 | 2,5 | Agreements between OCT-PIs and OCT-site should be signed before study approval |
Regulatory submission and approvals may vary per country. However today study approval timelines are distinct for each country.
OCT specializes in providing Regulatory Affairs support in Russia, Ukraine, Bulgaria, the Baltic States, and Belarus:
- Document preparation for study submission to Regulatory bodies;
- Study submission to Regulatory bodies;
- Final approval for the conduct of the clinical study in the Regulatory Authorities and Ethics Committees;
- Ongoing submissions in the Regulatory Authorities and Ethics Committees;
- Approval in the local committees for ethics;
- Insurance for participants of the trial;
- Design and negotiation of contracts with clinics, where clinical and pharmaceutical research is performed;
- Design and negotiation of contracts with investigators;
- Obtaining permissions to import/export investigative product, biologic specimens and medical equipment;
- Certification of imported equipment;
- Translation services, including back translation and proofreading;
- Import/export license
- Recommendations on cargo marking, corrections;
- Safety reporting to the local regulatory bodies;
- Creation of product labels;
OCT has experience in obtaining approvals for bioequivalence, phase I-IV, post approval studies in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia and Bulgaria. OCT is happy to provide this service as standalone service or as a part of clinical program.
