RLS staff comprise of highly qualified and experienced professionals who manage all aspects of clinical trial phase I and Bioequivalence/Bio-availability studies including: Project management, study conduct and monitoring, volunteer screening, medical writing, bio-analytical evaluation, data management & statistics, quality assurance services. we perform the following activities:
- Development of Protocol, ICD, CRF and Investigator brochure.
- Preparation & Submission of IND to regulatory body.
- Preparation & Submission of IND to regulatory body.
- Investigator selection and finalisation.
- Getting ethics committee’s approval)
- Coding, and dispensing of samples to investigators.
- Co-ordination with the investigators for subject enrolment.
- Responsibility for successful completion of studies.
- Analysing and preparation of clinical study reports.
- Responding to regulatory agency’s request for information pertaining to product safety.
