Your Specialized
Wound Care CRO

About Us

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

Two professionals in lab coats observe a computer screen, engaged in discussion in a lab environment.
A healthcare professional speaks with an older man, providing guidance and support in a medical environment.

Management Team

Bent von Eitzen
Bent von Eitzen
CEO

20 years experience in the wound care industry. Leading roles at EWMA, ISDF & ALPS.

Morgan Zelen
Morgan Zelen
COO, (MBA, CCRP)

11 years experience in clinical research directing trial operations at a leading US based CRO.

Mark Cregan
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

Phase 02

Evaluating Effectiveness

Phase 03

Confirming Findings

Phase 04

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.

As your trusted partner, we craft tailored strategies to reduce costs, mitigate risks, and ensure your protocol meets global regulatory requirements.
Services

CRO Services

At GCRI, we work as an extension of your team, providing seamless support at every stage of the clinical development process—from study design to study close-out.

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:

01

Global Feasibility & Site Selection

Success in early-stage clinical development…

02

Study
Start-Up

At GCRI, we simplify the complexities of clinical trial…

03

Patient Access and Recruitment

Recruiting the right participants is one of the…

04

Data Management

GCRI: Full-Service Data Management for Clinical…

Specialized Fields

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
Regulatory Standards

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