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R&D Services is managing all the administration of clinical trials conducted in public, municipal and private health care institutions.
About us
R&D Services has more than 50 sites situated on the territory of the whole country where clinical trials can be conducted.
The company’s general responsibilities are:
- To improve the quality of the collected data during the clinical trials.
- Building up a trial site at each healthcare institution and providing all the necessary equipment for conducting clinical trials and premises for proper document and study drugs storage, in compliance with the Good Documentation Practice, Good Clinical Practice and Good Manufacturing Practice.
- Ensuring protocol compliance, compliance with the International Conference on Harmonisation – Good Clinical Practice guideline, Bulgarian legislation and specific requirements of the Sponsor/CRO.
- To cooperate in providing the necessary documents for the initial study submission.
- Prescreening of eligible patients during the initial review/approval period so that a maximum number of patients can be enrolled for minimum time.
- Redirecting of eligible patients from trial sites that do not participate in the trial to sites that are approved; building a referral network of physicians to support the study enrollment.
- The quality check of all the needed documentation concerning the proper conduct of a clinical study (eCRF, temperature logs, subject logs, study drug accountability logs.
- Reporting the adverse events on time to the Sponsor/CRO.
- Ensuring access for audit on behalf of the Sponsor/CRO, independent auditor, Regulatory authorities.