A Proven Dual-Focus Specialty CRO for Women’s Health and Diagnostics
Health Decisions is a full-service CRO specializing in clinical studies of therapeutics for women’s health indications and studies of diagnostics for all 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 has provided services enabling many developers of both women’s health products and diagnostics to meet their development and business goals and looks forward to successful collaborations with many more. We take pride in offering the flexibility to tailor services to each sponsor in a manner that builds on the strengths of both development partners.
The CRO of Choice for Products that Address Any Aspect of Women’s Health
Health Decisions is committed to building the world’s leading CRO in women’s health. The commitment to leadership in clinical development of women’s health products includes products for traditional OB/GYN indications like menstrual disorders, contraception, sexual health and menopausal symptoms as well as gynecologic oncology indications and breast cancer. However, this commitment also encompasses all health conditions that affect women profoundly or disproportionately in fundamental health or quality of life. This extends to autoimmune disorders like multiple sclerosis and rheumatoid arthritis and other high-female-prevalence health conditions like migraine and depression. Health Decisions is determined to accelerate clinical development of therapeutics and diagnostics to improve healthcare outcomes for women in all these types of indications. We summarize this broad commitment in a single sentence: If it matters to women’s health, it matters to Health Decisions.
Outstanding Capabilities for Diagnostics Development in All Therapeutic Areas
Health Decisions provides efficient, high-quality clinical development services for diagnostics across the therapeutic spectrum. Diagnostics have long played a critical role in healthcare and clinical development. However, the explosion in the identification of biomarkers and development of molecular diagnostics has made the role of diagnostics more critical than ever. Health Decisions has provided successful development services for a variety of types of diagnostics in indications including but not limited to colorectal cancer, urothelial carcinoma, respiratory indications, sexually transmitted infections and tests for amniotic infection and risk of preterm birth. Health Decisions is committed to supporting diagnostics developers as they lead the transition to precision medicine, support biopharma development, enable better-informed treatment decisions and improve healthcare outcomes for people around the world. That is why we say: If diagnostics matter to you, you matter to Health Decisions.
Since 1989, Health Decisions has conducted more than 300 clinical trials, including more than 100 studies in women’s health indications and more than 20 studies of diagnostics. Health Decisions dual focus on clinical development in women’s health and diagnostics includes several studies bridging the two focus areas. The focus on women’s health was there from the beginning. Extension into diagnostics occurred more than a decade ago with a PMA study of a diagnostic for high-risk HPV types. Regulatory approval and clinical adoption of the HPV diagnostic markedly improved screening for cervical cancer, enabling early detection that likely reduced the number of women whose HPV infections evolved into precancerous lesions and cervical cancers. Other Health Decisions successes include clinical development of a wide variety of contraceptives, including drugs, devices and drug/device combinations. Approval of these contraceptives has provided women with a greater selection of acceptable alternatives for managing their reproductive health. Successful development of women’s health diagnostics and novel contraceptives are but two examples of Health Decisions fulfilling its mission to improve health outcomes for women worldwide. Other Health Decisions studies have advanced clinical development of therapeutics and diagnostics in areas as diverse as vasomotor symptoms, pain management following childbirth, STIs, bacterial vaginosis, assessing risk of preterm birth and multiple sclerosis.
Instrumental in FDA Approval
It is so exciting to report that yesterday afternoon we received FDA APPROVAL for the combination program!!! You were instrumental in helping make the amendments to the protocol that the FDA requested within a day’s notice. Kudos!!!! Your team at Health Decisions has been wonderful and so responsive throughout this whole process. I cannot thank you enough!
Operational Excellence & Quality
I liked the day-to-day interaction with the excellent project manager and all the team members, the quality of the CRAs and their visit reports and time from LPLV to DB Lock given the complexity of the study and the excellent quality of the final database.
Communication & Clarity
The level of interaction and communication and the clarity of discussion about who should do what and when were excellent. So were the business-oriented discussions that benefited both us and Health Decisions.
The Value of Timely Information
When something happened in the field, it was on my desktop in minutes or hours. We would literally react within 24 hours of receiving certain information and make changes either to things we did at specific sites or updates to the protocol. Partnering with Health Decisions enabled us to change and change quickly.
Effective Virtual Team
I appreciated the good team spirit and integration with our staff to make an effective virtual team.
Fast, Accurate Answers
The centralized point of contact had fast, accurate answers – I didn’t have to get transferred among many staff members to get answers or get action on something. She always returned calls and responded to emails quickly and with the information I was looking for.
Culture of Immediate Correction, Commitment to Quality
We love your culture of immediate correction where possible. This speaks to a commitment to quality of a type we rarely see. We are also impressed with Health Decisions’ responsiveness. You are doing what you say you’re doing. We have audited a lot of CROS and put Health Decisions in the top tier of all CROs we have audited.
Able to Get Products to Market and Recognize Less Promising Products Early
Health Decisions has multiple examples of being able to get useful products to market and recognize less promising products early on, reducing the financial risk of development.
Board of Directors
For an oncology biologic program, we worked with the client to combine PoC and dosing studies into a single study based on ability to continuously track outcomes. One of the other key features was continuously projecting where the study would end up, based on data to date. The design provided for stopping the study when an adequate signal was defined. This contrasts with the rigid fixed-sample traditional approach that may leave the sponsor with too much or too little data. Less than halfway through the planned timelines, the predictive probability of success exceeded 94% with reasonably tight credible intervals.
Health Decisions functions as a full-service virtual development organization for an innovative women’s health company, formulating program strategy and designing and executing studies of products in a variety of indications. The program is progressing rapidly toward NDAs.
Health Decisions terminated a clinical study of a pain therapeutic in osteoarthritis early for futility, enabling the sponsor to identify a responsive subpopulation and refocus resources, demonstrating an approach to increasing efficiency in a CNS clinical trial.
Health Decisions completed a metastatic breast cancer study a full year ahead of schedule and saved the sponsor approximately $2 million in direct costs through agile enrollment and a tiered global enrollment strategy, demonstrating the ability to achieve rapid enrollment and reduced cost in oncology clinical trials.