Precision Medicine


Health Decisions applies the techniques and lessons of precision medicine to every clinical study.

Increased understanding of the genetic make-up of each individual is transforming biopharma and diagnostics development and linking the fields more closely than ever. Genome-wide association studies have identified patterns of single nucleotide polymorphisms (SNPs) shared by patients with the same disease, enabling researchers to explore previously unrecognized disease mechanisms and biopharma developers to explore new development targets. Similarly, diagnostics companies are able to create novel assays that utilize biomarkers to diagnose and differentiate disease states and predict patient response. Based on experience managing precision-medicine trials of both targeted therapeutics and IVDs in a variety of indications, Health Decisions understands the profound implications of precision medicine in areas including patient recruitment and prediction of patient responsiveness and risk of side effects. Health Decisions assists both drug and IVD companies in conducting successful precision-medicine trials as well as in applying the techniques of precision medicine to all studies.

Precision Medicine Services for Biopharma and Diagnostics Companies

Health Decisions provides services for developers of precision medicines and associated IVDs in areas including:

Drugs and Biologics

  • Program Planning
  • Protocol Development
  • First-in-Human and Straight-to-Patient Trials
  • Biomarker Validation
  • Proof of Concept and Dose Selection
  • Confirmatory Trials

Diagnostics

  • Program Planning
  • Protocol Development
  • Validation and Reproducibility Studies
  • Method Comparison Studies
  • Clinical Utility Studies
  • Premarket Approval (PMA), 510(k) Clearance and CLIA Waivers

Applying Precision-Medicine Techniques to All Studies

Health Decisions applies the techniques and lessons of precision medicine to all trials as appropriate in areas including:

  • Biomarker Validation
  • Site Feasibility and Selection
  • Patient Screening and Recruitment
  • Refining Inclusion/Exclusion Criteria for Future Studies
  • Adaptive Design
  • Adaptive Operations: Enrollment, Quality Measures, Monitoring
  • Selection of Appropriate Assessments
  • Ensuring Consistent Administration of Assessments