For each trial a dedicated team composed of an experienced Project Manager and CRAs are assigned to conduct the study according to ICH/GCP, local regulations and SOPs.
Our experience in tracking trial site status via electronic systems, regular updating of investigator files, close following up study sites in terms of patient recruitment and retention and proper fulfilment of local laboratory procedures and contract processes improves the credibility of the research.
Rapid information flow, including weekly status reporting Monitor’s own format and detailed monitoring visit reports are maintained in compliance with sponsor timelines.
Regular site contacts and short contact visits are implemented to track down and fulfil site requirements as well as for contract negotiation and finalization and/or SAE reporting and query resolutions.
- Bioequivalence & Bioavailability
- Phase I, II, III, IV