Clinical trials are essential to deliver new therapies and advance medical knowledge and patient care. A key aspect of a successful clinical trial is the efficient management of clinical sites

  • Study design: Biometricians help design clinical trials, including determining sample size, randomization methods, and appropriate statistical tests to minimize biases and errors

Site management activities followed before study start-up

  • Management and review of clinical trial feasibility
  • Site qualifications – Site selection and pre-study visits
  • Selection of study investigator
  • Contract and budget execution
  • Vendors approval and setup

Site management activities at the time of study start-up

  • Oversee start-up
  • Site activation, site initiation visits
  • Set recruitment expectations
  • Ensuring training

Site management activities during the enrolment period

  • Facilitation and review of enrolment
  • Ensuring regulatory compliance and adherence to the protocol
  • Management of adverse event reporting
  • Study document review and query resolution
  • Data collection

Site management activities during study close-out

  • Ensuring protocol adherence
  • Addressing data queries
  • Ensuring final source data verification of study documents
  • Managing the collection of final safety data
  • Review and accountability of all study drug
  • Assessment and collection of all relevant regulatory documents
  • Ensure audit readiness
  • Ensure record retention requirements

Our key to strong collaboration with the sites is ensuring proper site management throughout all phases of a trial. Strong collaboration ensures increased efficiency, consistent communication, adherence to regulations and improved data quality

  • We focus more on Site selection and feasibility
  • Development of recruitment criteria
  • Managing patient recruitment
  • Inbuilt quality assurance mechanisms
  • Assurance of Good Clinical Practice (GCP)
  • Communication with sites
  • Customizable training based on the needs of the study
  • Managing of local ethics review processes