Since 1997, D-TARGET experts have helped to navigate the maze of medical device and diagnostic clinical research. D-TARGET appreciates the unique requirements of medical device and diagnostic manufacturers and is exclusively dedicated to supporting their clinical research activities.
Strategic and regulatory advisory services, clinical trial set-up through to post-marketing surveillance and registry support
Whether you have a small ten patient feasibility study or a 10,000 patient post marketing trial, D-TARGET offers total life cycle partnership ranging from strategic and regulatory advisory services, clinical trial set-up and operations through to post-marketing surveillance and registry support.
Our approach is working proactively in partnership with you in order to maximise your study goals. Part of the Premier Research Group since 2007, we can bring global services that combine the talent of a large group of research professionals in Clinical Trial Management, Biometrics and Regulatory to address your needs.
Certified quality system for medical devices
D-TARGET services for medical devices are based on an Swiss TS active certified quality system, in accordance with ISO 9001 and ISO 13485. All employees are trained according to the same internal training system. Our quality system corresponds both to the ISO 14155 and GCP guidelines applicable in the EU and 21 CFR part 812, 50 and 56 applicable GCP rules in the US, as well as additional national laws and regulations applicable to the conduct of clinical investigations.
With currently >70 fully employed experts in the field.
Clinical expertise and services
In the past ten years we have worked on 250 clinical projects with around 35,000 patients enrolled throughout Europe and the US. Ranging from small ten patient first in man clinical investigations, to 3,500 post market surveillance trials, working with all classes of devices.
Additionally, D-TARGET has supported the medical device industry with more than 90 consultancy projects. Currently we are working with 248 sites in 27 countries in Europe, North America, South America and Asian -Pacific. Services include:
- Medical affairs and strategic consulting
- Regulatory affairs
- Clinical trial management
- Clinical safety support
- Data operations
- Medical writing
- IVRS, IWRS and ePRO
- Quality assurance
Key opinion leader network
Avenue des Sciences 11
1440 Yverdon les Bains
Tel: +41 244 242 6 88
234 Copeland Street
Quincy, MA 02169
Tel: +1 617 237 1111
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