Clinical Research Associate (CRA) Services

We ensure that clinical trials are conducted, recorded, and reported according to the protocol, GCP, and applicable regulatory requirements. CRAs serve as the main link between the sponsor and the investigator site.

Site Management

Site Identification & Feasibility: Assessing potential sites based on capability, recruitment potential, and experience.
Site Initiation Visits (SIVs): Conducting training on protocol, GCP, investigational product (IP), and documentation.
Monitoring Visits: Routine Monitoring: Verifying source data, CRF entries, investigational product accountability, and regulatory compliance.
Remote Monitoring (if applicable): Document review and site communication via electronic platforms.
Close-Out Visits: Ensuring study materials return, data resolution, and site archiving.

Investigator and Site Support

Providing ongoing training and guidance to investigators and study coordinators.
Acting as the sponsor’s liaison with the site, addressing operational and logistical concerns.

Data Integrity & Quality Assurance

Verifying source data (SDV) to ensure accuracy and completeness of CRF entries.
Ensuring timely resolution of queries and deviations.
Escalating protocol violations or non-compliance issues to sponsor and QA team.

Documentation & Reporting

Maintaining trip reports, action items, and visit schedules.
Ensuring the Trial Master File (TMF) is up to date and inspection-ready.

Regulatory & Ethics Compliance

Assisting sites with ethics committee submissions, regulatory filings, and essential document maintenance.
Ensuring informed consent process is followed and documented properly.