Health Decisions is a full-service CRO assisting sponsors in conducting individual phase 1 – 4 clinical studies as well as in supporting programs from pre-IND and pre-IDE discussions through successful NDAs, PMAs and 510(k)s. We are committed to understanding each sponsor’s needs and preferences and tailoring our services accordingly. Our pledge is to embrace your development and business goals and serve as an extension of your project team.
Health Decisions and our executive team have extensive experience in collaborating with sponsors from early stages of clinical development through regulatory submission. This includes experience implementing a variety of models for project and program governance as appropriate based on the scope of each strategic engagement and the needs and preferences of each sponsor. Health Decisions welcomes inquiries about strategic collaborations. Our goal is to serve as an extension of your development organization. We are committed to structuring projects and programs for the mutual benefit of Health Decisions and our sponsor partners.
Agile Trial Management and Operations
Health Decisions utilizes a proactive, data-driven approach to trial management and operations. This approach relies on timely performance metrics and continuous decision-making. Each Health Decisions project team develops a comprehensive project management plan for each study, identifying risks and specifying mitigations, Key Risk Indicators and triggers for intervention. Project teams track progress closely, intervene at the first sign of an issue and refine project and risk management throughout each study. The agile approach to trial management and operations consistently delivers high efficiency and data quality to sponsors of Health Decisions studies.
Health Decisions has provided clinical development services for sponsors of investigational drugs and medical devices in a wide variety of therapeutic areas and indications. Our experience and capabilities encompass conducting clinical studies in areas including:
- Endocrine and metabolism
- Infectious disease
- Therapeutic medical devices
- Surgical medical devices
Health Decisions provides sponsors with flexible global reach enabling them to conduct a global study in the most favorable locations without incurring overhead costs from nonparticipating regions and sites. We provide global agility through a combination of data-driven central management from the US with the regional experience, expertise and insight of carefully selected resources in each country or region. Primary project management and lines of communication from Health Decisions’ global headquarters in the US keep the sponsor current on the study as a whole and performance of all sites regardless of location. Health Decisions provides sponsors with access to 75 countries served by more than 50 offices and 1,500 staff through carefully selected partner CROs.