Clinical Services
We are offering a full set of clinical consultancy services
CLINICAL STRATEGY AND TRIAL SUPPORT
Our clinical strategy and trial support will provide you with a clinical strategy in line with the current expectations of the authorities to maintain state of the art clinical data.
Clinical data and clinical evaluation has become an ever more important pillar for showing your medical device safety, performance and efficacy. Increased demands on proper clinical data requires a proper clinical strategy planning.
Clinical Strategy
Continuous development of medical device laws, influenced by globalization and harmonization, has increased the complexity of its interpretation and practical implementation.
Although the medical device directives and regulations have become more standardized with a more uniform structured approach, demands on the pre-clinical requirements and clinical strategy have increased.
MedQ Consultants B.V. can support you in:
- Finding the optimal clinical strategy for your device
- Provide support in literature and state of the art review
- Support in the clinical evaluation reporting
- Assessment of your pre-clinical requirements
Clinical trial support pre- and post CE marking
The most important element of getting your medical device approved is the implementation of a fundamental clinical trial strategy. Our pre- and post-market clinical trial support service provides you access to guidance and support with the current medical device regulatory demands and market access requirements. By optimizing the trial setup, the trial conduct is optimized and avoids redundancy and cost. Having a sound clinical medical device trial strategy to support your clinical evaluation will benefit both your single market and (future) multi continent approach.
MedQ Consultants B.V. will assist you where needed in the preparation, conduct and management of your pre- and post-market clinical trials according to the European Regulation and country specific requirements.
MedQ Consultants B.V. can support your trial with:
- Pre-Market and Post Market Clinical Trial Management
- Regulatory Submissions dossiers for the Ethics Committees and Competent Authorities, Radiation Board as well as local authorities.
Support on essential (country specific) documentation and preparation of Study Documentation Preparation/Review among others;
- Clinical Investigation Protocol
- Investigator’s Brochure, local dossiers
- Case Report Form (CRF)
- Patient Information and consent forms
- Clinical Site Selection, Qualification, Initiation, Monitoring, Close-out
- Safety Reporting to Ethics Committee and/or Competent Authorities
- Electronic Data Capture (EDC) system setup and support
- Statistical Analysis clinical data
- Prepare final clinical trial report