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Site Management

CBCC-Vibgyor has established working relationships with a large network of experienced, qualified, and skilled investigators and high-performing sites spanning multiple therapeutic areas across the country for drug and device trials. Various factors are evaluated before selecting a site for a clinical trial such as past experience, performance, enrolment track record, study compliance, infrastructure, quality, experience, and integrity of research staff.

 

CBCC-Vibgyor’s site management model is designed to help the investigators focus on patient management while the clinical research related activities are managed by our dedicated staff to ensure that the study is conducted with the highest level of commitment, quality, and integrity by adhering to protocol and all applicable regulatory guidelines.

Our Site Management Service includes following:

  • Ethics committee dossier compilation, submission, and follow-up
  • Site communication and coordination
  • Negotiations for Budget, Clinical Trial Agreements, Investigator Grants, and Patient reimbursements
  • Participation in PI meets and training
  • Screening and short listing of potential patients for enrolment in studies
  • IVRS Randomization for studies
  • Site IP management, dispensing, and accountability
  • Clinical Trial Supplies management
  • Coordinating with Central/Core Lab for logistics and smooth sample flow
  • Maintaining and updating Investigative site Files
  • Translations, couriers, and third party vendor support services
  • Preparation, participation, and follow-up of monitoring visits and audits
  • Resolving data queries and Archival at site
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