Clinical Evidence Services
Brief Summary of our Clinical Evidence Services
New European Medical Device Regulation
What clinical evidence does your strategy require?
We partner with you to review the need for evidence in the context of your strategy and your markets.
We are able to provide clinical literature reviews for study design and as independent publications.
Study design is carried out as a separate project. Study design is reviewed against the EWMA Patient Outcome Group Recommendations for controlled and comparative studies on non healing wounds* as well as ISO 14155-1 and the CONSORT guidelines.
* Outcomes in controlled and comparative studies on non healing wounds: Recommendations to improve the quality of evidence JWC Vol 19.No.6 June 2010 Ewma Patient Outcome Group.
Our familiarity with the wound care world in the EU and N.America enables us to propose both "Key Opinion Leader" and lower profile sites for clinical evidence programmes.
We conduct Site Feasibility Reviews to GCP standards.
We provide a turn-key service of all regulatory submissions and tracking.
Our qualified team in the UK provides all core Study Documentation and project management. We work with qualified local CRAs and Clinical Project Managers to deliver site logistics and monitoring.
Data Management services using SAS software is provided.
We provide statistical modelling for literature reviews and study designs and carry out statistical analysis of study results.
We provide medical writing services for all Study Documentation including the Clinical Investigation Plan (protocol), Investigator's Brochure, Case Report Form, Patient Information and Informed Consent Forms and the final Study Report submitted to the regulatory authorities.
We provide writing for publication for clinical and scientific journals, covering both case studies and formal studies. Articles are written by clinicians and medical writers experienced in writing on wound care. We offer peer reviews before final submission to the journals.
Why ask Wound Market Consulting to help you with your Wound Care Product Clinical Evidence?
Because your business can benefit from us...
Specialising in Wound Care and having international multi-disciplinary wound care experience from product concept to marketing through to the design of your whole programme.
Bringing an experienced commercial perspective to the discussion of which programme and audience will best achieve your goals.
Having an overview of the Wound Care Centres suitable for your studies.
Designing & conducting trials & evidence programmes solely in wound care, so we are aware of the opportunities & pitfalls in Wound Care Trial design, execution and the publication of final results.
Having a flexible hub and spoke structure which enables us to adapt to changes in your objectives and to offer a full "turn-key" service and to keep costs down.
Having a comprehensive range of both Market Access & Clinical Evidence services which allows us to support you through all stages of product development and enables you to select a package of services tailor made to meet your needs.
Other WMC Services
Reimbursement researching requirements, completing and filing applications for reimbursement to aid you in increasing sales of your product.
Bespoke Market Research gathering intelligence first hand from the clinical & commercial professionals who influence the success of your product in the market.
Market Assessments enabling you to assess the value / feasibility of entry to your target market/s.
Distributor Identification to ensure that in a world of many product offers and few strong independent wound acre distributors you have the best partner for your product.