Clinical Consulting Expertise for Wound Care Studies
Successfully bringing innovative wound care solutions to market presents a number of unique challenges to medical device and biologic companies.
Clinical trials and studies must be designed to balance the need for rigor with the need for efficiency and speed. Patient-reported outcomes need to be accurately and consistently gathered, checked and assessed throughout the study rather than after the fact. The process of collecting health economics data needs to be built into your initial study, rather than running a costly additional study after regulatory approval and incurring delays in reimbursement.
Friction can build up between CRO and clinical site personnel during the process of monitoring patient compliance and outcomes if the electronic data capture (EDC) system is not designed to accommodate the unique needs of wound care studies.
Finally, gaining FDA approval for new wound care treatments requires specialized expertise in developing strategies and project plans that meet regulatory requirements, and in managing interactions with the FDA during the submission and approval processes.
For more than 30 years, Health Policy Associates, Inc. (HPA) has been providing an unmatched breadth of clinical consulting expertise to the end-to-end process of bringing innovative new wound care therapies to market. HPA’s unique experience includes:
- Clinical trial strategy/execution: HPA has worked extensively with clients, including several of the top-10 wound care companies, on numerous studies in a wide range of areas, including:
- VLUs (venous leg ulcers)
- Diabetic foot ulcers
- Incisional/post surgical wounds
- Chronic and acute wounds
- VAC (vacuum assisted closure) therapies
- Pressure wounds (i.e., bedsores, etc.)
- Open abdominal wounds
- Stem-cell-derived therapies
- Deep wounds
- FDA submissions: HPA has successfully shepherded a large number of IDE (investigative device exemption), IND (investigational new drug), NDA (new drug application), 510(k), BLA (biologic license application) and PMA (pre- market approval) applications through the FDA.
- Data management and analysis: HPA has designed wound-healing-specific, customized electronic clinical databases for multiple indications.
- Monitoring: HPA has a proven track record of efficient, site-friendly monitoring, and solid, established relationships with high-enrolling KOL sites.
- Quality system management: HPA has unique experience balancing quality system requirements with the need for efficiency and speed to ensure the smooth, rapid delivery of new wound care therapies to market.