The following fact sheets illustrate how Health Decisions’ insights and operational techniques have enabled sponsors in many indications to achieve striking development successes.
Capabilities in Reproductive and Women’s Health Studies
October 18, 2016
Download PDFThis fact sheet summarizes Health Decisions’ capabilities in reproductive and women’s health studies, including studies of contraceptive drugs, devices and combination drug/devices and studies in assisted reproductive technology, vasomotor symptoms, prenatal and postpartum conditions, menstrual disorders and many other indications. The fact sheet includes a case study of development of an emergency contraceptive from preclinical through phase 3 and marketing approval.
Therapeutic Expertise Overview
October 2, 2016
Download PDFThis fact sheet provides an overview of Health Decisions’ broad spectrum of therapeutic expertise, including extensive experience with both drugs and medical devices in reproductive and women’s health and many other therapeutic areas and indications. Health Decisions’ data-driven Agile Clinical Development methodology enables earlier, better management decisions that optimize operations in all therapeutic areas.
October 1, 2016
Download PDFRead this corporate overview about Health Decisions CRO+ and why we are a leader in reproductive and women’s health and the CRO of choice for biopharma, diagnostics and medical device companies worldwide, offering a unique combination of development insight, expertise, processes and technology and delivering excellence in every aspect of clinical research.
Health Decisions Consulting Services
September 18, 2016
Download PDF Health Decisions tailors consulting services to the needs of each client, whether consulting for specific projects, outsourcing on a Functional Service Provider (FSP) model or establishing a strategic partnership with a formal governance structure. Our unique combination of development insight and expertise has enabled us to assist many sponsors in regulatory strategy, program planning, protocol development, study design and optimization of operations.
IVD Development Services
November 11, 2014
Download PDFHealth Decisions’ integrated IVD development services offer the design and operational excellence and regulatory expertise required to develop IVDs successfully and eliminate risk of delays in the 510(k) clearance or PMA review process. Health Decisions offers exceptional capabilities in large subject-based clinical trials of novel IVDs, including molecular diagnostics, immunoassays and other types of IVDs.
Agile Clinical Development
June 26, 2014
Download PDFThis fact sheet summarizes Health Decisions’ Agile Clinical Development, a methodology that optimizes every aspect of clinical studies and programs, including both operations and design. The Agile Clinical Development methodology is the most comprehensive in the industry – a unique combination of continuous, comprehensive refinement of trial operations and selective optimization of key parameters
such as sample size utilizing adaptive design techniques. Health Decisions’ systems and processes provide streaming data and role-specific information that enable earlier, better decisions at all levels of trial management and execution throughout the life-cycle of each study, the essence of Agile Clinical Development.
LiveTrial, the Information Engine for Agile Clinical Development
June 25, 2014
Download PDFLearn how Health Decisions’ LiveTrial, the information engine for Agile Clinical Development, streams LiveData, enabling earlier, better decisions that increase efficiency and reduce timelines for clinical studies of drugs and medical devices. LiveTrial’s three major components – the LiveTrial Clinical Trial Management System, Clinical Data Management System and Study Collaboration & Management Portal – all work from the same integrated database, eliminating typical data transfers from multiple internal systems, ensuring rapid data availability for the study team throughout the lifecycle of each study.
Agile Risk-Based Monitoring+
June 24, 2014
Download PDFLearn about Health Decisions’ Agile Risk-Based Monitoring+, the industry’s most advanced approach to risk-based monitoring. Agile Risk-Based Monitoring+ simultaneously reduces SDV and increases data quality. Agile RBM+ is consistent with regulatory guidance on risk-based monitoring but goes far beyond, delivering exceptional value as well as ensuring data quality and patient safety.
Capabilities in CNS Studies
June 22, 2014
Download PDFHealth Decisions’ capabilities in CNS studies include experience with indications such as Autism Spectrum Disorders, Major Depressive Disorder, Alzheimer’s disease and addictions and substance abuse. This fact sheet includes case studies of a phase 2 autism study and a phase 3 global Alzheimer’s study.
Capabilities in Medical Device Studies
June 20, 2014
Download PDFLearn about Health Decisions’ capabilities in medical device studies, including cardiovascular and contraceptive devices and particular strength in large-subject-based IVD studies. This fact sheet includes a case study of a 4,000+ subject registration study of a novel molecular HPV diagnostic.
Capabilities in Early Phase Studies
June 19, 2014
Download PDFLearn about Health Decisions’ capabilities in early phase studies based on a flexible, high-speed, high-quality approach, including the ability to provide rapid data access for key decisions in dose-escalation studies.
Capabilities in Vaccine Studies
June 18, 2014
Download PDFLearn about Health Decisions’ capabilities in vaccine studies, including systems and processes that provide near real-time access to safety and reactogenicity data. The fact sheet includes a case study of a phase 2 influenza vaccine study.
Capabilities in Infectious Disease Studies
June 17, 2014
Download PDFLearn about Health Decisions’ capabilities in infectious disease studies and experience in a variety of infectious-disease indications. Read a case study of a phase 2 trial of a novel therapeutic for Acute Bacterial Skin and Skin Structure Infections.
Capabilities in Gastroenterology Studies
June 16, 2014
Download PDFLearn about Health Decisions’ capabilities in gastroenterology studies involving a variety of indications. Read case studies of a phase 2 Inflammatory Bowel Disease study and a 12,777-subect study of a diagnostic for colorectal cancer.