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