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
COVID Update
Team IDRS is committed towards working on complex products in niche therapeutic areas to address the unmet medical needs. This extends to the current challenging time, where the entire scientific community is working towards bringing some therapeutic option to provide relief from Covid-19 and associated complications. Our team, in collaboration with some of the premier Indian Institutes, is fervently working on a phytopharmaceutical product that will not only provide an option to treat Covid 19 patients but also minimise post Covid complications. Watch this space for further updates.