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.
Health Decisions offers the flexibility necessary to collaborate with sponsors based on their needs and preferences, utilizing the complementary strengths of both parties. For some sponsors, Health Decisions has supported development from the formulation of regulatory strategy through marketing approval. Our clinical, biostatistical and regulatory experts enjoy early engagement and the opportunity to add maximum value to development programs. However, we also perform specific roles such as protocol development, biostatistical analysis or data management on a Functional Service Provider model. Health Decisions welcomes the opportunity to discuss your needs and tailor our service offerings accordingly.
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.
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. In addition to supporting more than 150 studies in women’s health indications, Health Decisions experience includes pediatric studies in ADHD, growth disorders and adolescent psoriasis; oncology studies in breast cancer, prostate cancer, lung cancer and renal cell carcinoma; neuroscience experience in depression, ADHD, stroke, methamphetamine and cocaine dependence; studies of infectious disease such as bacterial vaginosis, HIV and diagnostics for Chlamydia trachomatis, Neisseria gonorrhea, HPV and influenza; and pain management experience in postsurgical pain, osteoarthritis of the knee, lumbosacral radiculopathy and migraine. Health Decisions welcomes inquiries for studies in therapeutic areas and indications including the following:
Endocrine and metabolism
Renal cell carcinoma
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 the performance of all sites regardless of location. At the core of Health Decisions’ global coverage is a strategic alliance for women’s health clinical trials with European CRO Comac Medical. Comac, with headquarters in Sofia, Bulgaria, operates in 24 countries in Western, Central and Eastern Europe. Over more than 20 years, Comac’s extensive women’s health experience includes 79 trials in OB/GYN indications including uterine fibroids, heavy menstrual bleeding, contraception and menopause; breast cancer and gynecologic cancers; and other high-female prevalence indications such as migraine, osteoporosis, multiple sclerosis, lupus and rheumatoid arthritis. 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.
Why We Do It: The Health Decisions Wish for Every Baby Girl
The images and text below encapsulate the Health Decisions wish for every baby girl as her healthcare needs evolve throughout the lifecycle. 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
- A trouble-free transition to maturity in a secure, respectful environment Danielle Kroft 2017-10-03T21:36:25-05:00
- Babies conceived if and when she chooses and delivered after healthy, full-term pregnancies Danielle Kroft 2017-10-03T21:36:34-05:00
- An active, independent life after fulfilling personal and career goals Danielle Kroft 2017-10-03T21:36:57-05:00
- Senior years with the ability to enjoy her favorite activities and maintain her independence and dignity Danielle Kroft 2017-10-10T02:02:25-05:00