What we do
Prometheus Bio-Medical is Full Service Contract Research Organization (CRO) that provides resources and support to pharmaceutical and biotech companies conducting clinical trials.
Clinical Trial Monitoring
Clinical Research Associates (CRAs) ensure the integrity of the study, adherence to protocol, quality of measurements, safety of Subjects, and the collection of valid data. We provide global monitoring and site management solutions to our clients via our international team of experienced professionals. All our CRAs are Medical Doctors (MD) and have a minimum of five years' experience prior to joining our organization and are knowledgeable in all aspects of study conduct. We also have the flexibility to use less experienced staff if required. They are highly skilled, therapeutically aligned, centrally trained, and committed to excellence in every study.
Furthermore, Prometheus Bio-Medical has developed a specialized CRA Training Programs, where we select talented professionals and cultivate their skills through an extensive training program on all facets of clinical research and trial oversight. This unique program allows us to introduce more individuals to clinical research careers, and increases our pool of skilled CRAs to support clients' programs.
Prometheus Bio-Medical’s monitoring services include:
- Site qualification visits (Pre-Study Visit-PSV; Site Qualification Visit-SQV, Site Evaluation Visit-SEV)
- Collection and Submission of all essential document for review and approval to the regulatory authority of Georgia (Ministry of Health’s Drug Approval Agency)
- Assistance to sites in Submission and obtaining Ethics Committee approval
- Site initiation visits
- Site interim monitoring visits
- Site close out visits
- Source document review
- Regulatory document review
- Product accountability
- Report generation