Clinical Development Services

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.

Design Stage

  • Drafting Study Documents like Protocol, ICF, IB, CRF, study manuals etc.

Execution Stage

(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
  • Biostatistics

Reporting Stage

  • Drafting CSR
  • Regulatory Dossier compilation & filing