Wound Market Consulting

Clinical Development

Clinical Trials can be long and expensive. We bring a 360° experience of the wound care market to the choice of objectives, study design and implementation to deliver good quality and commercially relevant evidence.

Regulatory

International Regulatory experience and comprehensive strategic thinking applied to your product design, prototype and regulatory pathway.

Clinical Trial Design

Experienced in trial design for diverse wound care technologies and strategic objectives we challenge and support your thinking throughout the clinical trial development process.

Clinical Trial Documentation

All Trial Documentation is written to ICH-GCP, ISO 14155: and MDR standards for medical devices. We offer a turn-key service or can write just those documents you choose to outsource.

Data Management & Statistics

Our network provides Data Management & Statistical Analysis services using SAS9.4 software.

Clinical Evaluation Report

A Medical device sold in Europe, irrespective of its classification, must have an up-to date Clinical Evaluation Report (CER) as part of its technical file. Wound Market Consulting can support, compile and provide expert advice to ensure compliance against the necessary requirements.

Clinical Trial Monitoring & Management

Monitoring and managing clinical trials is complex, requiring rigorous attention to detail, and a dynamic problem-solving approach. Partnering with Wound Market consulting will provide you with access to industry experts and a project team specialised in wound care.

Medical Writing for Publication

At Wound Market Consulting we combine all our disciplines within wound care to offer a bespoke service to draft and review literature and articles for publication.