Your Specialized
Wound Care CRO
GCRI is a full-service niche CRO focusing on indications where we have a detailed knowledge and even more important, where we have a strong network.
The indications we focus on are:
Wound Care
Orthopedic Surgery
Dermatology
Management Team
Bent von Eitzen
CEO
20 years experience in the wound care industry. Leading roles at EWMA, ISDF & ALPS.
Morgan Zelen
COO, (MBA, CCRP)
11 years experience in clinical research directing trial operations at a leading US based CRO.
Mark Cregan
CMO (PhD)
30 years experience in clinical re-search, with 15 years experience in leading clinical trials in academia, followed by 15 years in the medical industry.
Solutions
Phase I-IV Clinical Trials
Phase 01
Establishing Safety
Evaluating Effectiveness
Confirming Findings
Post Market Clinical Trial Follow-Up (PMCF)
At GCRI, we bring in-depth expertise across all clinical trial phases, offering comprehensive support from planning and recruitment to monitoring, data management, and trial completion.
CRO Services
With expertise in clinical trials for drugs and medical devices, we offer flexible services tailored to your needs. Whether as a full-service partner or by managing specific work packages, we excel in:
Therapeutic Areas
Our scientific focus includes breakthrough research in:
01
Wound Care
Successfully planning and executing clinical trials in specialized fields like wound care, diabetic foot syndrome, orthopedics, and dermatology requires seamless collaboration among multiple stakeholders.
02
Diabetic Foot Syndrome
03
Orthopedics
04
Dermatology
Quality and Compliance
Quality
Working with competent authorities for the specific studies.
EUDAMED ready under MDR (EU) 2017/745 and IVDR (EU) 2017/746, and CTR (EU) 536/2014 and CTIS compliant.
- Efficient Registration Support
- Timely Clinical Investigation Submissions
- Protocol Updates and Amendments
Compliance
We guarantee full compliance with global regulatory standards, including FDA, MDR/CTR (EU), ISO 14155, ICH Guidelines, and more – so your clinical investigations run smoothly and efficiently.
- Ensures consistency and accuracy of documentation
- Simplifies translation and localization of content
- Provides a centralized repository for all documentation