Health Decisions is a proven full-service specialty CRO for women’s health and diagnostics in all therapeutic areas with additional capabilities in studies of drugs and medical devices in a range of other therapeutic areas. Health Decisions has focused on women’s health since its inception more than 28 years ago, conducting more than 100 trials in women-only indications such as contraception and postmenopausal vasomotor symptoms. More than a decade ago, Health Decisions expanded into diagnostics studies with a large PMA study of a screening test for high-risk HPV types – the precursors of cervical cancer. Building on the success of the HPV study, Health Decisions has conducted successful diagnostics studies in a variety of other indications in women’s health and beyond, including diagnostics for risk of preterm birth, STIs, a variety of respiratory indications and oncology indications such as colorectal cancer and urothelial carcinoma.
Health Decisions offers comprehensive clinical development services for drug, diagnostics and medical device companies. We have successfully conducted full-service trials involving tens of thousands of patients at hundreds of investigational sites and resulting in successful NDAs, PMAs and 510(k)s. While Health Decisions generally provides full services for each clinical study, we pride ourselves on the flexibility to adapt our service offerings to the needs and preferences of each sponsor and project. Our experts have consulted on program planning, regulatory strategy and study design and have provided a variety of statistical services for developers of both drugs and diagnostics. In addition, we have served as a Functional Service Provider for data management and clinical monitoring. Our service offerings include:
The data-driven Health Decisions approach to trial management reduces risks and timelines and increases efficiency. A detailed project management plan incorporates risk management and monitoring plans that focus the project team on activities most critical to study success. During the planning process, project teams identify key risks and mitigations, define Key Risk Indicators and determine triggers for intervention. The project team tracks performance closely during execution and intervenes rapidly when necessary to keep studies on time and budget. The project team updates the risk-management plan as appropriate to reflect the operational challenges encountered during the study.
Health Decisions utilizes a team-based approach to site monitoring and offers a variety of monitoring strategies to ensure high data quality while minimizing cost. For each site, an in-house monitor is the primary site contact and performs central data checks and remote monitoring as required by each study. The field monitor for the site performs onsite visits that are more focused and efficient because of information provided by the in-house monitor. To meet the needs and preferences of each sponsor, Health Decisions offers a range of monitoring strategies, including risk-based, reduced SDV and 100% SDV. Health Decisions submits its monitoring recommendations for the sponsor’s review and approval to ensure that the monitoring plan appropriately balances considerations of quality and cost.
Study Design & Protocol Development
Health Decisions biostatisticians work closely with the sponsor and therapeutic experts to identify endpoints and inclusion/exclusion criteria and select conventional and adaptive design techniques as appropriate for each program and study. The protocol development process analyzes not only therapeutic, statistical and regulatory considerations for the study but also the operational implications of design choices. For example, selection of inclusion/exclusion criteria gives careful consideration to effects on patient eligibility given the standard of care and patient flow at real-world sites.
Regulatory & Quality
Regulatory services include identifying the optimal regulatory pathway and strategy for each drug or diagnostic and supporting sponsors from pre-IND or pre-IDE meeting through regulatory submission. Services include support for sponsor meetings at FDA. The quality management team has extensive experience providing oversight of compliance by the project team and participating vendors and ensuring the quality of processes and deliverables for each study.
Data Management & Biometrics
The Health Decisions data-management group has capabilities refined in a wide variety of trials, implements Good Clinical Data Management Processes (GCDMP) and utilizes forms and tools in CDISC/CDASH format. Experience with assessments in all therapeutic areas enables the data-management team to provide rapid startup and database build for each trial. The Health Decisions biometrics group develops the statistical analysis plan early in each study. This identifies issues of interest and key variables in the data, focuses priorities in the collection, review, validation, and updating of study data, and defines any planned interim analyses. Early completion of the statistical analysis plan allows the data-management team to focus data checks throughout the study on areas that defend the statistical analysis. For the analysis, the statistical team creates and validates required programs and displays and the project statistician develops the analysis databases, produces data displays for subject characteristics, treatment exposure, compliance and primary study objectives, and validates CRF listings and data displays of secondary study objectives. An independent quality assurance group audits statistical tables while the statistical team completes the statistical methods section of the clinical study report.
LiveTrial EDC implements the numerous required management, technical and operational controls required for clinical trial compliance with the Federal Information Security Management Act (FISMA). LiveTrial has been in operation since 2013, has been continuously upgraded and improved with new features and functionality, and meets the rigorous security and privacy requirements of both FISMA and 21CFR11. FISMA compliance is a requirement for participation in federally funded clinical studies. However, security improvements from FISMA compliance benefit commercially sponsored studies as well. In addition to LiveTrial, Health Decisions offers two other EDC systems. Our tiered offering of three EDC systems enables us to meet sponsor’s data-management needs in a wide range of clinical trials.