What We Do

Health Decisions provides efficient, high-quality clinical development services for sponsors of women’s health products as well as diagnostics and medical devices for all therapeutic areas. We have assisted sponsors in conducting many 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. Download an overview of Health Decisions’ services and a fact sheet on Health Decisions’ consulting services.

Early Engagement

Health Decisions focuses on identifying complementary strengths to form a partnership that addresses sponsors’ needs and preferences. Health Decisions has supported development programs from the formulation of regulatory strategy through marketing approval. Our clinical, biostatistical and regulatory experts feel early engagement creates the opportunity to add maximum value to development programs. We also perform specific roles such as Biostatistics & Programming, Clinical monitoring, Data Management, and Project Management as a Functional Service Provider. Health Decisions welcomes the opportunity to discuss your needs. 

Agile Trial Management and Operations

Health Decisions utilizes a proactive, data-driven approach to trial management and operations, relying on timely performance metrics and continuous decision-making. Each Health Decisions project team develops a comprehensive project management plan, identifying risks and specifying mitigations, Key Risk Indicators, and triggers for intervention. Project teams intervene at the first sign of an issue and refine project and risk management throughout each study. This agile approach consistently delivers high efficiency and data quality.

Therapeutic Experience and Expertise

Health Decisions has successfully conducted clinical studies of drugs and medical devices in a wide range of therapeutic areas and indications, with a focus in indications that impact women. Based on years of experience and aided by a site network of more than 500 high-performing women’s health sites, Health Decisions delivers clinical studies tailored to meet sponsor, patient, and regulatory needs. More than 90 percent of the Health Decisions’ staff specialize in women’s health research, allowing for hand-selected study teams uniquely suited to address the challenges of developing assets in areas including reproductive and sexual health, menopause, pain management, osteoporosis, osteoarthritis, and gynecologic oncology. Additionally, Health Decisions conducts diagnostic and medical device studies in all therapeutic indications, including women’s health, oncology, and infectious disease.

Global Approach

Health Decisions provides sponsors with flexible global reach enabling study execution across North America and Europe, without excess overhead costs. A combination of data-driven central management, women’s health expertise, and insight of carefully selected regional resources ensures operational agility. Strategic global alliances further enhance our offerings, including a partnership with European CRO Comac Medical. Globally, Health Decisions provides sponsors with access to 75 countries served by more than 50 offices and 1,500 staff through carefully selected partner CROs.

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Why We Do It: The Health Decisions Wish for Every Baby Girl

Together with our sponsors, the investigators in our site network and the women enrolled in our clinical studies, we are committed to doing all we can to make this wish come true. Our goal is nothing less than to ensure that at every stage of life, all girls and women have access to:

  • all the diagnostics necessary to identify their health issues early and accurately and enable informed treatment decisions and optimal outcomes

  • all the therapeutic drugs and devices necessary to manage reproductive health, maintain well-being, treat disease and ease discomfort