Phase II-IV Clinical Trials:
Clinical Trial Management and Monitoring

Pharmacovigilance
Through a team of dedicated and experienced pharmacovigilance associates, RCRS provides a comprehensive and reliable 'Safety Services Portfolio' which includes;

Study and Sponsor specific, dedicated Pharmacovigilance associates
24 x 7 receipt and processing of Serious Adverse Events (SAEs)
Capability to enter data directly into sponsor's safety database
Rapid medical & regulatory assessments of SAEs for reportability
Established pharmacovigilance follow up and management practices
Timely transmission of safety issues to sponsors, Regulatory Affairs & ECs / IRBs
Liaison between investigators and medical monitors at sponsor groups across varying regions and time zones .
Coding of medical terms and medications using MedDRA & WHO-DD
Narrative writing
Designing & conducting Post Marketing Safety (Phase IV) studies & safety data collection
Site safety audits for compliance
Management of safety issues associated with Medical Devices & 'Product Technical (Quality) Complaints
Medical literature search for regulatory submission
Training Sponsors / Investigators in Safety reporting infrastructure & processes