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.
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.
Regulatory & Ethics Compliance
Assisting sites with ethics committee submissions, regulatory filings, and essential document maintenance.
Ensuring informed consent process is followed and documented properly.
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.
Documentation & Reporting
Maintaining trip reports, action items, and visit schedules.
Ensuring the Trial Master File (TMF) is up to date and inspection-ready.