Clinical Operations

Clinical Operations

BA/BE studies are one of our Key services, we offer end-to-end solutions in this arena. Our cross-functional team has extensive experience in executing and managing Bioequivalence studies covering various therapeutic areas and most more complex studies.

Our Key services includes:

BA / BE Studies

  • BA / BE studies on patients and healthy subjects
  • Jeevan execute the study through its qualified partner and our CRA monitor the conduct of study
  • Healthy subject and Patient based studies
  • Mixed Gender and Post menopausal studies
  • PK/PD end point studies
  • Single and Double blind studies
  • Execution of studies on various range of formulations injectable, Suspensions and liquids
  • Studies on Controlled drug substances
  • Single and Multiple dose studies (fast and fed)

Phase II to IV

  • Phase II to IV trials of diverse therapeutic areas
  • Clinical operations team has rich experience in conducting multi-centric and multi-national clinical trials

Trial Management

  • Our Project Managers work effectively and diligently to manage critical aspects of the study and ensure on-time delivery of results, within budget and with the high quality
  • Creation, collection and review of regulatory documentation
  • Correspondence with IRB/IEC and concerned authorities
  • Trial and site management
  • Management of budget and project timelines

Trial Monitoring

  • Our skilled and well-trained clinical research associates (CRAs) ensure the quality of data and maintains effective communication with study site coordination’s. Our CRAs conduct on-site visits on periodic basis during the study to
  • Oversee data collection
  • Review source data and case report forms
  • Ensure regulatory and protocol compliance
  • Resolve data queries