Health Decisions has extensive experience with a variety of medical device clinical trials and programs, including PMA and 510(k) studies and studies of therapeutic and surgical devices.
Health Decisions’ Expertise in Medical Device Clinical Trials and Programs
Our medical device experience includes studies of:
- Carotid artery stents
- Endovascular stent grafts
- Stent graft in arteriovenous graft for hemodialysis
- Combination drug/device for pain management
- Surgical devices
- Combination drug/device for contraception
- Other contraceptive devices, e.g. vaginal rings, diaphragms, male & female condoms.
Medical Devices Success Stories
Rapid Enrollment in a Vascular Device Trial
Health Decisions accelerated enrollment of a vascular device trial through close tracking, rapid analysis and activation of a prescreened second tier of sites identified based on large patient volume and the ability to start up rapidly.
Rescue Effort Enabling Regulatory Submission in a Stent Study
Health Decisions salvaged data from a study of a carotid artery stent by developing a flexible process to identify and correct mistakes and inconsistencies, transfer and clean all data from a previous CRO and prepare the data for database lock. This involved re-querying all data, recoding adverse events and merging two disparate databases, one of which had a high error rate. The sponsor commented that Health Decisions’ “excellent communications and problem solving made the difference in making this trial successful.”
Reduced Timelines, High Retention in a 510(k) Contraceptive Device Study
Health Decisions provided full-service support for a 510(k) application for a novel contraceptive device, including completing a 500-subject study of safety and efficacy and an associated biomarker substudy one month ahead of schedule. The retention rate was 15% greater than anticipated in the protocol.
Download a fact sheet summarizing Health Decisions’ capabilities in medical-device studies. Download Fact Sheet