Case Studies


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The following case studies illustrate how Health Decisions’ insights and operational techniques have enabled sponsors in many indications to achieve striking development successes.


Case Study of Large PMA Study of CRC Diagnostic

October 18, 2016

Download PDFRead this case study to learn how Health Decisions successfully addressed complex challenges in cohort management, sample management and subject compliance in a >12,000-subject PMA study of a novel noninvasive screening diagnostic for colorectal cancer.


Case Study of 510(k) Study of Diagnostic for Respiratory Infections

October 3, 2016

Download PDFThis case study describes how Health Decisions successfully addressed multiple challenges in a 510(k) study of a novel diagnostic for respiratory tract infections. Challenges addressed included ensuring rapid sample collection and accurate sample tracking, maintaining sample integrity and performing effective cohort management to meet goals for demographic diversity.


Case Study of HPV Diagnostic Clinical Trial

September 16, 2016

Download PDFBy conducting a highly efficient clinical trial, Health Decisions helped an innovative young diagnostics company save $ millions on their development costs and beat a giant competitor to market by more than two years. This case study summarizes how we did it.


Influenza Vaccine Clinical Trial Case Study

January 16, 2014

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Health Decisions provided the sponsor of a Phase I Influenza vaccine clinical trial with immediate access to safety data through innovative technology and also accelerated timelines and conserved limited development funds. This case study provides highlights of this phase I trial.


CNS Clinical Trial Case Study: Pivotal Study of an Alzheimer’s Drug

Download PDFSuccessfully addressing issues that have jeopardized the success of more than one CNS clinical trial, Health Decisions accelerated enrollment and reduced variability of subjective assessments in a global phase III Alzheimer’s study, substantially reducing timelines and costs.


Metastatic Breast Cancer Clinical Trial Case Study

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A small biotech company turned to Health Decisions for its phase III metastatic breast cancer clinical trial involving a new formulation of a previously marketed drug. Health Decisions saved the sponsor a full year of development time and $2 M in costs, enabling earlier access to an effective oncology therapeutic that greatly improved quality of life for millions of women.


Universal Flu Vaccine Clinical Trial Case Study

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Health Decisions used its Agile Clinical Development methodology and innovative technology to provide near real-time safety data and accelerate enrollment for a sponsor’s Universal Flu Vaccine candidate with the potential to immunize against a wide assortment of seasonal and pandemic influenza strains.