Clinical Trial Strategy and Execution (DRAFT-2)

Health Policy Associates utilizes robust and streamlined processes that enable us to accomplish our commitment to quality and timelines within budget for your clinical trials. Our experienced team tailors a project plan to address the varied needs of each project and executes that plan seamlessly in partnership with your team.

Our key clinical operations services include:

  • Strategy and Study Design
    • Determining appropriate study design and endpoints, clinical trial strategies, and data requirements
    • Collecting supportive data, publications, and literature
    • Preparing study materials such as protocols, CRFs, Informed Consent Forms, study logs, and study worksheets
    • Representing sponsor with regulatory agencies
  • Study Start Up
    • Identifying and qualifying sites and investigators
    • Preparing documentation for IRB and/or Ethics Committee approval
  • Project Management
    • Tracking overall study progress and progress of individual sites
    • Customized reports for your team with critical study metrics (including deviations, enrollment rates, and adverse events with trend analyses)
    • Developing a randomization scheme and either paper or web-based subject randomization
    • Managing study supplies and interactions with third party vendors (including core labs)
    • Preparing for meetings with regulatory agencies (including FDA Q-Subs and FDA Advisory Panel meetings)
  • Clinical Monitoring
    • Customizing risk-based monitoring for individual protocols
    • Developing a Monitoring Plan detailing study monitoring procedures and risk evaluation
    • Programming edit checks to flag increased areas of risk or non-compliance
    • Confirming subject eligibility and investigator compliance with applicable regulations (including appropriate consenting practices and adverse event reporting)
    • Reviewing and verifying key study data
    • Identifying and resolving any problems at individual study sites during trial
  • Biostatistics
    • Developing a Statistical Analysis Plan, randomization schemes, and sample size justifications
    • Generating statistical summary tables, graphs, and reports within SAS for regulatory submissions, presentations, and publications
    • Performing interim and final statistical analysis
  • SAS Programming
    • Converting raw data into CDISC-compliant formats including SDTM, ADaM, and ECTD for analysis and submission to regulatory agencies
    • Generating Tables, Listings, and Figures from derived datasets for inclusion in submissions, books, journals, manuscripts, and web publications
  • Clinical Report Preparation
    • Summarizing study design, patient assessments, demographic data, data analysis and results, product failures and replacements, risk-benefit analysis, device safety and effectiveness, and other metrics
    • Medical writing to reflect trial outcomes and support study objectives
  • Audit Preparation
    • Preparing for and supporting announced or unannounced inspections of clinical trials by FDA or notified bodies
    • Assessing audit readiness with a thorough and inclusive review of quality system, SOPs, staffing levels, organizational structure, and study files
    • Customized training and education to ensure a successful audit