Clintrex Services

Clinical Development Plan

The SMART CLINICAL TRIALS approach to clinical trials involves some or all of the following services. It is designed to minimize error, optimize relevant subject selection, reduce sample size, and increase the chances of obtaining an accurate and reliable determination of study success or failure in a timely and efficient manner.

    • Protocol Design and Writing
      • Ensure that optimal entry criteria, outcome measures, sample size, analytic methods, and compliance with regulatory requirements are employed
      • Innovative study methodologies, including complex or adaptive designs, if appropriate
    • Site and Investigator Selection
      • Use personal contacts and first-hand knowledge to select optimal sites and investigators based on their expertise and track record — not simply their potential to enroll large numbers of subjects without consideration of the quality of the data.
      • Use personal relationships and influence (Eigenfactor) to encourage the best investigators to participate in studies, expedite site activation, and minimize drop-out.
    • Investigator Meetings
      • Work with site investigators and coordinators to ensure they understand study rationale, study design, outcome measures, as well as appropriate use of rating scales and instruments and to ensure that diagnostic criteria, enrollment, and study instruments are employed in a consistent manner by all participants
    • Enrollment Committee
      • Develop a Randomization Authorization Form (RAF) to provide specific information on each patient
      • Have leading disease experts in the field review the RAF for each candidate prior to enrollment to ensure that all potential subjects meet entry criteria, diagnosis is correct, and candidates are suitable for the study.
    • Investigator Interaction
      • Interact with investigators throughout the study to ensure they remain engaged.
      • Support Investigators to facilitate enrollment, minimize drop out, resolve operational issues, and ensure that quality data is provided in a timely manner
    • Continuous Data Monitoring
      • Seek and address data anomalies and aberrant trends so they can be corrected at an early stage
    • Biostatistical and Database Services
      • Develop or oversee database creation, statistical analysis, and report generation
      • Interpretation of data, regulatory reporting

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