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, biostatistics and clinical monitoring. Our service offerings include trial management, monitoring, data management and biostatistics, regulatory and quality, and study design and protocol development. Download an overview of Health Decisions’ services.
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.
Data and Quality Management
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. Learn more about Health Decisions’ capabilities in data management from this fact sheet. Health Decisions’ offers sponsor’s a choice of three EDC systems, including Health Decisions’ proprietary LiveTrial EDC. LiveTrial not only meets 21 CFR Part 11 requirements but also implements the numerous required management, technical and operational controls required for clinical trial compliance with the Federal Information Security Management Act (FISMA). A white paper provides additional information about the benefits of LiveTrial, the Health Decisions FISMA-compliance solution. The Health Decisions’ 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.
The Health Decisions biostatistical 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.
Study Design and Protocol Development
Health Decisions’ biostatisticians provide study design and protocol development as integrated deliverables on full-service contracts or as separate consulting services. Our biostatisticians select conventional and adaptive design techniques as appropriate and work closely with the sponsor and therapeutic experts to identify endpoints and inclusion/exclusion criteria 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 involves a close analysis of effects on patient eligibility based on the standard of care and patient flow at real-world sites.
Health Decisions’ experts provide an array of medical, biostatistical, operational and regulatory consulting services to assist sponsors at every stage of clinical development programs. Medical consulting often focuses on identification of endpoints to demonstrate the efficacy and safety of the investigational product. Health Decisions’ medical consultants also advise on selection of inclusion/exclusion criteria to ensure that a study enrolls the appropriate patient population. Our biostatisticians collaborate closely with the sponsor’s project team to identify the optimal design techniques to ensure that a study meets the sponsor’s support a biostatistical analysis that as appropriate for each program and study. Health Decisions’ operational consultants assist sponsors in addressing key issues including site feasibility and selection and recruitment strategy. Health Decisions assigns regulatory consultants as appropriate for each investigational product and indication to identify the optimal regulatory pathway and strategy and advise on requirements for meeting the sponsor’s strategic and business goals. Health Decisions supports sponsors from pre-IND or pre-IDE meeting through regulatory submission. Services include support for sponsor meetings at FDA. Learn more about Health Decisions’ consulting services from this fact sheet or request additional information about consulting services.