Project Management and Clinical Trial Monitoring
SPRI Ukraine project management offers high quality services in the specialized areas of planning, communication and relationship building among Investigators, Sponsor and other parties. Our aim is to provide your projects with all the expert support.
SPRI Ukraine recruits experienced CRAs both in-house and field-based. SPRI's employees are specifically trained according to GCP standards. Our study monitors strategically assess the capacity of individuals and organizations to deliver effective services.
- Monitoring clinical trial progress
- Source document and clinical data verification
- Preparing monitoring reports
- Recruiting potential investigators
- Reporting adverse events
- Submitting documents to regulatory authorities
- Assuring patient compliance
Site visits provide the opportunity to discuss recruitment approaches, potential problems and ensure the adherence to the ICH GCP requirements, SOPs used in the study and all applicable local authority regulations.
SPRI's study coordinators ensure the following:
- Assistance in contacting potential research centers and interacting with other departments and clients regarding study process;
- Preparation of sponsors visit to the research center;
- Assistance in study site administrating;
- Maintaining well documented, organized and up-to-date site files.