2GL Outsourcing provides clinical trial related services to a contract research organizations (CRO), pharmaceutical companies, biotechnology companies, medical device companies or clinical sites. The site is usually a hospital or a similar health care institution that has adequate infrastructure and staff to meet the requirements of the clinical trial protocol. Our services include:
- Contract development, negotiation and execution
- Regulatory set up (Submission for the Independent Ethics Committee (CA/CEC) and Regulatory approval)
- Patient Recruitment assistance (development of recruitment tools)
- Site initiation and trial close-out operations
- Independent monitoring
- Trial-related documents archival and maintenance
- Medical Monitoring/ Safety Reporting (SAE) to the Sponsor or CRO and the CA/CEC and RA
- Data Protection Counseling
- Management of Protocol Violations (Advising & alerting investigators of potential protocol violations)
- Management of ICH GCP violations (Advising & alerting investigators of potential ICH-GCP violations)
- Development of Site SOP’s/Site Quality Assurance
- Site training (ICH GCP, Regulatory, Ethics)
- Data Management
- Patent Protection Management
- Feasibility Studies
- Project Management
- Medical writing/Protocol Development and CRF Design