Site Management

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