Clinical Trial Services
Economics & Quality of Life Assessment Group
The EQOL Group is dedicated to providing economic assessments that aid in the development of new medical therapies.
Economic assessments are becoming an increasingly important component of the development of new medical therapies. Sponsors may need to demonstrate that new therapies are not only safe and efficacious, but that they also improve patient-centered outcomes at a reasonable cost.
Making that assessment requires expert trial design, sophisticated biostatistics, and diligent follow-up of patients in clinical trials. These are services that the EQOL Group at HCRI is dedicated to providing.
The EQOL Group has extensive experience in both industry- and NIH-sponsored trials. Over the past ten years it has been involved in more than 50 clinical trials of medical devices, new drugs, and gene therapies.
The group is led by a board-certified internist and cardiologist, trained in outcomes research and cost-effectiveness analysis at the Harvard School of Public Health. For each project, the group meets to develop a coordinated, well-thought plan for achieving the sponsors’ goals. The EQOL project team is composed of experienced health economists, biostatisticians, project managers, research coordinators, and patient interviewers.
The group’s services include:
Making that assessment requires expert trial design, sophisticated biostatistics, and diligent follow-up of patients in clinical trials. These are services that the EQOL Group at HCRI is dedicated to providing.
The EQOL Group has extensive experience in both industry- and NIH-sponsored trials. Over the past ten years it has been involved in more than 50 clinical trials of medical devices, new drugs, and gene therapies.
The group is led by a board-certified internist and cardiologist, trained in outcomes research and cost-effectiveness analysis at the Harvard School of Public Health. For each project, the group meets to develop a coordinated, well-thought plan for achieving the sponsors’ goals. The EQOL project team is composed of experienced health economists, biostatisticians, project managers, research coordinators, and patient interviewers.
The group’s services include:
- Trial design
- Case report form design
- Instrument development and validation
- Economic data collection
- Patient surveys
- Biostatistical analysis
- Manuscript preparation
- Preparation of pharmacoeconomic submissions to FDA
- Post-marketing reports
- Presentations to CMS and other 3rd party payers for support of reimbursement SOPs that ensure quality
