IDRS will work with its partner CRO (or with a CRO selected by Sponsor, if any) to execute End to End Clinical Trial. This model can be applied to BABE studies, Phase II and Phase III and PMS studies.
- Drafting Study Documents like Protocol, ICF, IB, CRF, study manuals etc.
(Regulatory & ClinOps)
- Regulatory dossier compilation and filing
- Site feasibility
- Site Identification and Site selection visits
- Ethics Committee Dossier compilation and filing
- Site training and site initiation visits
- Site Monitoring and CRF collection
- Clinical Data Management
- Drafting CSR
- Regulatory Dossier compilation & filing