Clinical Trial Strategy and Execution

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