Services
Clinical Operations & Trial Management
One accountable team that runs your study in India from feasibility to final report, or plugs into your own operations as a functional service provider.
Request a proposal →Our clinical operations team has managed domestic and international trials from start to finish. A dedicated project manager owns your study and is your single point of contact with sites, vendors and ethics committees.
Choose full-service delivery, or pick the functions you need to complement your internal staff.
Study start-up
- Feasibility assessment and site selection
- Investigator evaluation, qualification and selection
- Protocol and CRF design and review
- Informed consent development and review
- Ethics committee submissions
- Trial Master File (TMF) set-up
Study conduct
- Project management and sponsor reporting
- Selection, training and management of therapeutically qualified CRAs
- Risk-based monitoring plans and source data verification
- Site initiation, interim, remote and close-out visits
- Rapid resolution of protocol non-compliance
- Medical and safety monitoring
Close-out and reporting
- Database lock support
- Interim and final reporting
- TMF reconciliation and archiving
- GCP audits and training
Discuss clinical operations for your study
Tell us about your protocol, timelines and therapeutic area, and we will suggest how ACRS can support it.