Clinical Research Services
Feasibility and Site selection
- We understand the value of time and economics attached with it.
- We have short turnaround time for feasibilities.
- We coordinate with sites to prepare them for Pre-initiation and feasibility visits.
Staff support
We have well qualified and ICH-GCP Trained Clinical Research Co-ordinators.
An experienced coordinator brings quality to the study, documentation and data.
By Placing a well trained CRC we ensure:
- Quality documentation
- Minimizing Protocol deviations by ensuring proper execution of protocol.
- Regular notifications and submissions to Ethics committee.
- Timely resolution of queries.
- Assist in adhering to SAE reporting timelines. With recent development of SAE reporting to be done in SUGAM(India) a trained CRC can help in quickly updating detailed SAE report into the portal.
Trial Management
- Logistical support to site by a network of local vendors.
- Pre-study site setup.
- Placed CRC ensures all pre study EC approvals, CTA signatures are done within expected timelines through regular followup.
- Subjects eligibility check as per protocol.
- Maintaining essential documents
- Up to date trial master file management.
- Ensuring Quality source documentation by conducting regular meetings and trainings PI and staff if required.
- Drug accountability, preparation and dispensing as per the study protocol requirements.
- Smooth and efficient conduct of study from feasibility to study completion.
Patient recruitment and retention
- Assist in achieving recruitment timelines through strategic referral networks.
- To help create awareness of active studies among other hospitals and clinics.