Phase II – III Clinical Research

Clinical Trial Management

With a performant team working under an accomplished Clinical Project Manager, from onset to the entire clinical trial process, everything is planned, implemented and executed in-line with our sponsor's expectations. The Project Manager also acts as a primary liaison to our sponsors.

Project Management Services:

  • Project Plan development, Feasibility assessment, Investigator and Site selection
  • Study set-up and site start-up
  • Organize Investigator Meetings and Site training
  • Resource, mentor, co-monitor support and monitor report reviews of CRA
  • Manage Third party vendors
  • Ensure subject safety and regulatory compliance
  • Manage study supplies and clinical site payments
  • Manage sponsor communications
  • Ensure compliance of the trial team performance with all applicable regulatory requirements, project-specific SOPs and industry best practices
  • Manage client expectations for on-time and on-budget performance

Study Start-up

We at CBCC behold a proven track record of completing the start-up activities on short notice with stringent timelines.

Activities under Study Start-up:

  • Identify Site for feasibility
  • Prepare Feasibility questionnaire
  • Assess site NDA and feasibility
  • Site qualification visits
  • Collect IU, PSP, 1572 etc.
  • Compile and Submit EC dossier
  • Compile and Submit DCGI dossier

Site Selection and Site Relationship Management

CBCC has established professional relationships with a large network of proficient investigators and high performing sites. The process of site selection is rigorous where factors including enrolment track records, experience, performance, study compliance, infrastructure, quality and integrity of research staff are evaluated.

Site Management Services:

  • Identify and develop Clinical Trial sites for various therapeutic areas
  • Compile, submit and follow-ups of ethics committee dossier
  • Communicate and coordinate with sites
  • Negotiate Budget, Clinical Trial Agreements, Investigator Grants, and Patient reimbursements
  • Participate in PI meets and training
  • Perform Screening and shortlisting of potential patients for enrolment in studies
  • Clinical Trial Supplies management
  • Coordinate with Central/Core Lab for logistics and smooth sample flow
  • Maintain and update Investigative site files
  • Translations, couriers, and third-party vendor support services
  • Prepare, participate and follow-up of monitoring visits and audits
  • Resolve data queries and archival at site

Patient Recruitment and Retention

  • Select and finalize inclusion and exclusion criteria carefully to ensure the recruitment of patients with a higher possibility of retention during the trial
  • Enrolment Planning – It comprises of robust site feasibility, advertising, preference to experienced network sites and the ones with a proven track record
  • Constant communication between the medical monitors and PIs to ensure precise identification of patients for the study
  • Patient Retention Strategies – It includes incentives to trial participants, proper counselling, newsletters, reminders for the visits etc.

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