THE LATEST IN WOMEN’S HEALTH
Capabilities for Clinical Studies in Female Sexual DysfunctionDanielle Kroft2018-12-11T19:59:01-05:00
Capabilities for Clinical Studies in the Genitourinary Syndrome of Menopause (GSM)Danielle Kroft2019-03-06T20:33:03-05:00
SERVICES
Trial Management
Trial Management
Health Decisions provides proactive project management for phase 1 – 4 trials of women’s health drugs as well as trials of devices and diagnostics for all therapeutic areas.
Monitoring
Monitoring
Health Decisions utilizes a monitoring approach based on team-work between field and in-house CRAs that ensures high data-quality and improves site performance.
Data and Quality Management
Data and Quality Management
The experienced Health Decisions data management and quality management groups ensure collection and delivery of high-quality data for each study.
Biostatistics
Biostatistics
Health Decisions’ biostatisticians provide statistical planning, design, programming and analysis to ensure that each study meets informational goals.
Study Design and Protocol Development
Study Design and Protocol Development
The Health Decisions biostatistical and clinical teams have extensive expertise in protocol development for phase 1 – 4 trials of therapeutics as well as for diagnostics trials.
Consulting
Consulting
Health Decisions’ experts provide medical, biostatistical, operational and regulatory consulting services to assist sponsors at every stage of clinical development.
Functional Service
Functional Service
Health Decisions FSP offers custom-built programs to power strategic development and organizational growth.
BUILDING THE WORLD’S LEADING CRO IN WOMEN’S HEALTH AND DIAGNOSTICS
“Health Decisions is committed to building the world’s leading CRO in women’s health and diagnostics. We have collaborated effectively with many innovative sponsors of women’s health and diagnostic products. Our leadership team and clinical development experts are truly passionate about improving women’s health and interested in learning how we can bring your product to market rapidly with minimal cost and risk. We are equally passionate about assisting diagnostics developers in efficiently demonstrating the clinical validity and utility of their products.” Patrick Phillips, BSc (Hons), D.Phil., Chief Executive Officer
What Women’s Health Means to Us
The Importance of Diagnostics to Health Decisions
Resource Library
- Health Decisions FSP CapabilitiesDanielle Kroft2021-02-02T13:02:52-05:00
Health Decisions FSP Capabilities
- A Women-centric Approach to Clinical TrialsDanielle Kroft2021-02-01T13:04:16-05:00
A Women-centric Approach to Clinical Trials
- Overcoming Burdens in a Trial of a Female ContraceptiveDanielle Kroft2020-10-21T14:06:00-05:00
Overcoming Burdens in a Trial of a Female Contraceptive
- DSP Clinical Research and Health Decisions: Partners Accelerating Research in Reproductive MedicineDanielle Kroft2020-10-19T15:54:12-05:00
DSP Clinical Research and Health Decisions: Partners Accelerating Research in Reproductive Medicine
- A Framework for Successful Pain Measurement in Clinical TrialsDanielle Kroft2020-10-21T12:15:14-05:00
A Framework for Successful Pain Measurement in Clinical Trials
- Considerations for Studies in Infectious Diseases of the Genitourinary SystemDanielle Kroft2020-04-16T19:24:09-05:00
Considerations for Studies in Infectious Diseases of the Genitourinary System
- Considerations for Clinical Studies in Migraine Prophylaxis and TreatmentDanielle Kroft2018-12-13T15:49:48-05:00
Considerations for Clinical Studies in Migraine Prophylaxis and Treatment
- Considerations for Clinical Studies in Heavy Menstrual BleedingDanielle Kroft2018-12-12T18:31:49-05:00
Considerations for Clinical Studies in Heavy Menstrual Bleeding
- Capabilities for Clinical Studies in EndometriosisDanielle Kroft2020-08-24T13:36:30-05:00
Capabilities for Clinical Studies in Endometriosis
- Capabilities for Clinical Studies in Female Sexual DysfunctionDanielle Kroft2018-12-11T19:59:01-05:00
Capabilities for Clinical Studies in Female Sexual Dysfunction
- Dual 510(k)/CLIA Waiver Study of a POC TestDanielle Kroft2020-01-13T19:47:48-05:00
Dual 510(k)/CLIA Waiver Study of a POC Test
- Capabilities for Clinical Studies in OsteoporosisDanielle Kroft2018-08-23T20:18:19-05:00
Capabilities for Clinical Studies in Osteoporosis
- Capabilities for Clinical Studies in ContraceptionDanielle Kroft2018-09-18T15:33:22-05:00
Capabilities for Clinical Studies in Contraception
- Case Study: Phase 3 Trial in Women’s Sexual HealthDanielle Kroft2020-10-05T08:32:56-05:00
Case Study: Phase 3 Trial in Women’s Sexual Health
- Diagnostics Development ServicesDanielle Kroft2019-01-14T17:52:21-05:00
Diagnostics Development Services
- Capabilities for Clinical Studies in the Genitourinary Syndrome of Menopause (GSM)Danielle Kroft2019-03-06T20:33:03-05:00
Capabilities for Clinical Studies in the Genitourinary Syndrome of Menopause (GSM)
- Capabilities in Women’s Health StudiesDanielle Kroft2020-10-21T12:32:23-05:00
Capabilities in Women’s Health Studies
- Large PMA Study of a Colorectal Cancer DiagnosticDanielle Kroft2020-01-03T14:18:33-05:00
Large PMA Study of a Colorectal Cancer Diagnostic
- Addressing the New Imperative to Include Females in Clinical TrialsDanielle Kroft2020-10-21T12:42:35-05:00
Addressing the New Imperative to Include Females in Clinical Trials
- Nine Tips for Success in Precision MedicineDanielle Kroft2018-03-28T21:32:57-05:00
Nine Tips for Success in Precision Medicine
- Ten Tips for Establishing the Clinical Utility of Molecular DiagnosticsDanielle Kroft2019-10-07T20:28:51-05:00
Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics
- LiveTrial Data Management as a ServiceDanielle Kroft2017-10-03T21:30:50-05:00
LiveTrial Data Management as a Service
- Perfecting Phase 2: Ten Essential StepsDanielle Kroft2020-01-13T18:39:30-05:00
Perfecting Phase 2: Ten Essential Steps
- 510(k) Study of a Respiratory DiagnosticDanielle Kroft2018-08-23T14:44:36-05:00
510(k) Study of a Respiratory Diagnostic
- Federal Contracting Capabilities OverviewDanielle Kroft2017-10-03T21:35:19-05:00
Federal Contracting Capabilities Overview
- Capabilities in Early Phase StudiesDanielle Kroft2017-10-03T21:35:28-05:00
Capabilities in Early Phase Studies
- Pivotal Study of an Alzheimer’s DrugDanielle Kroft2017-10-03T21:37:17-05:00
Pivotal Study of an Alzheimer’s Drug
- Capabilities in Gastroenterology StudiesDanielle Kroft2017-10-03T21:37:27-05:00
Capabilities in Gastroenterology Studies
- Phase 2c: Expedited Development for AllDanielle Kroft2018-09-24T17:29:40-05:00
Phase 2c: Expedited Development for All
- Webinar: Key Tips for Diagnostics in 2018 and Beyond – Development Success in the Evolving US and EU LandscapeDanielle Kroft2020-10-19T15:46:01-05:00
Webinar: Key Tips for Diagnostics in 2018 and Beyond – Development Success in the Evolving US and EU Landscape
- Webinar: Critical Success Factors in Reproductive Health Studies – Practical Tips for Minimizing Timelines, Risk and CostsDanielle Kroft2018-08-23T20:40:49-05:00
Webinar: Critical Success Factors in Reproductive Health Studies – Practical Tips for Minimizing Timelines, Risk and Costs
- Webinar: Heavy Menstrual Bleeding – Medical Background and PI and Patient Perspectives on Clinical TrialsDanielle Kroft2020-10-19T15:51:04-05:00
Webinar: Heavy Menstrual Bleeding – Medical Background and PI and Patient Perspectives on Clinical Trials
- Is a Specialty CRO Right for You?Danielle Kroft2020-10-14T13:05:47-05:00
Is a Specialty CRO Right for You?
- A Women-centric Approach to Clinical TrialsDanielle Kroft2021-02-05T13:57:10-05:00
A Women-centric Approach to Clinical Trials
- The Role of Male Contraceptives in Advancing Women’s HealthDanielle Kroft2021-03-03T10:56:47-05:00
The Role of Male Contraceptives in Advancing Women’s Health
