SPRI Ukraine Experience

SPRI Ukraine capitalizes on 9+ year clinical trial local experience, knowing respective procedures for clinical trials conduct in Ukraine and, of cause, on the established relationships with experienced investigators and industry opinion leaders. Our SOPs have been carefully developed to ensure compliance with local laws and FDA guidelines as well as to ensure effective clinical trial management and quality.

SPRI Ukraine has extensive experience with the procedures of the State Expert Center of the Ministry of Health of Ukraine based on a clear understanding of both local and international regulations.

Being an experienced local provider we can effectively help with important details like adapting an Informed Consent to local. SPRI Ukraine is aware of the expectations of the Competent Authority and Ethics Committees, knows the phrases to be included into ICF and which expressions may result in questions from the authority. This helps to avoid time-consuming change requests.

SPRI Ukraine maintains a full and up-to-date collection of the local regulations and all the related legal documents. Local lawyers are involved in this process keeping the pace better than any global CRO can.

Our project managers act as the link with the sponsor to ensure clear, concise communication and on-time performance every time. They are committed to maintaining flexibility and cost management. They are empowered to oversee every aspect of clinical trial management, handling changes and new objectives as they arise. Your project manager will be your single point of contact for every aspect of planning, coordination, compliance and operations.

We ensure efficiency at study start-up by providing a comprehensive binder to the site, detailing the required documentation for the study. We prefer to select clinical investigators we are familiar with to ensure fast turnaround for regulatory document processing and excellence in project execution. To maximize our monitors' ability to focus on the study and produce the best results, we assign CRAs no more than two studies at a time. Our CRAs have mostly 5+ year experience in clinical trials start-up and monitoring.