Clinical Research Unit (CRU)

The Clinical Research Unit (CRU) of the School of Medicine is established in the Department of Pharmacology on the 5thfloor, DY Patil University School of Medicine building.

The CRU provides a location and skilled staff for investigators conducting inpatient and outpatient clinical and translational research at the DY Patil Deemed to be University, Navi Mumbai.

The CRU services include clinical research facilities (supporting both outpatient and inpatient studies) and research support services.

The CRU functions as a Site Management Organization (SMO) that provides clinical trial related services to a contract research organization (CRO), a pharmaceutical company, a biotechnology company, a medical device company or investigators at DY Patil University.

Functions and responsibilities of SMO:

Contract with CRO’s and sponsors

Submission for Independent Ethics Committee (IEC) approval

Patient Counselling

Patient Recruitment

Patient Follow-up

Informed consent administration

Site feasibility and site selection activities

Site initiation and trial close-out operations

Trial-related documents archival and maintenance

Reporting serious adverse events to the Sponsor or CRO and the IRB/IEC

Ensuring protocol compliance

Advising & alerting investigators of potential protocol violations

Advising & alerting investigators of potential ICH-GCP violations

Clinsearch Healthcare Solutions Pvt. Ltd. (http://clinsearch.in/ )

Parshwa Life Sciences (http://parshwalifesciences.in/)

Collaborations/MOU of CRU, School of Medicine:

Clinsearch Healthcare Solutions Pvt. Ltd. (http://clinsearch.in/ )

Parshwa Life Sciences (http://parshwalifesciences.in/)