Therapeutic Expertise
Neuromodulation
Medical Device Expertise
D-TARGET has a long tradition in research for medical devices. Since 1997 our experts, purely dedicated to medical devices, are supporting all kind of medical device research activities. From 10 patients first in man to 3500 post marketing trials in EU and US. In the last 5 years we supported more than 150 clinical projects with more than 35000 patients.
Neuromodulation Experience
D-TARGET has managed 7 neuromodulation device trials over the last 5 years treating approximately 250 patients.
Besides that, D-TARGET has supported 25 trials with similar patient populations in the orthopedic/ spine and neuroscience field with more than 3000 patients.
KOL Network
D-TARGET is currently working with notable sites and key opinion leaders in Europe and the US.
Europe:
Leiden, Zwolle, Rotterdam, Leuven, Brussels, Geneva, Bern, Basel, Thun, Fribourg, Leipzig, Bad Nauheim, Dresden, Berlin, Munich, Bad Segeberg, Hamburg, Bad Krozingen, Munich, Bad Oyenhausen, Coburg, Vienna, Graz, Prague, Warsaw, Monaco, London, Leicester, Manchester, Milano,Lugano, Rome, Madrid, Barcelona, Stockholm, Malmö, Kopenhagen, Oslo, Rennes, Paris, Nantes, Toulouse and Bordeaux to just name a few.
US:
Boston, Philadelphia, New York, Austin, Columbus, Chicago, Oklahoma City, Cleveland, Birmingham, Charleston, Rochester, Ann Arbor, Charlottesville, San Francisco, Fresno, San Diego, Cincinnati, Denver, Los Angeles, Plano, New Haven
Start up
The D-Target start up team is involved in the activities planning from the first days of the company involvement. This allows timely planning of the submissions in the involved countries in advance. D-Target provides outstanding experience and expertise in the EC/IRB and authority submissions with excellent relationships to local EC/IRB and authorities. Very good knowledge of the local requirements is a great advantage of the D-Target start up team. Thanks to this experience D-Target can help significantly reduce time to first patient in.
Monitoring
Our CRAs or “monitors” are sourced from a clinical/nursing background and are familiar with the often present hierarchy of the hospital, particularly within the Operating Theater and Catheterization laboratory settings. D-TARGET CRAs have prior direct experience with medical devices and their application and are thoroughly trained on their roles and responsibilities in response to anticipating problems relating specifically to medical device trials. They can also provide technical support to sites if needed
CEC Support
D-TARGET understands the critical importance of CEC / DSMB support during medical device studies.
A dedicated CEC coordinator continuously monitors patient’s safety data and ensures CEC events are entered into the CRF in cooperation with the CRAs and sites. Our CEC coordinator will also prepare and reviews CEC packages before providing the full package to the clinical events committee for their review.
Neuromodulation Experience in detail
Device Type | Study Type | Sites | Patients | Services | Region | |
Analgesia |
|
|
|
|
|
|
Fibromyalgia | Transcranial Magnetic Stimulator | 2 | 1 | 30 | RC | NA |
Cardiovascular |
|
|
|
|
|
|
Hypertension | Baroreceptor Stimulator | Pilot | 8 | 55 | Full Service | WE, CE |
Hypertension | Baroreceptor Stimulator | Pilot | 1 | 10 | CM, MM, MW, PM, QA, RA | WE |
Hypertension | Baroreceptor Stimulator | PMS | 2 | 20 | MW | WE |
Endocrine/ Metabolic |
|
|
|
|
|
|
Obesity | Implantable Nerve Stimulator | Pivotal | 1 | 30 | CM, PM, RA | WE |
Genitourinary |
|
|
|
|
|
|
Urinary Incontinence (in Females) | Sacral Nerve Stimulator | Pilot | 4 | 50 | CM, MM, PM, RA | WE, NO |
Urinary Incontinence (in Females) | Spinal Cord Stimulator | Pivotal | 2 | 40 | BS, DM | NA |
Neuroscience |
|
|
|
|
|
|
Stroke | Implantable Brain Stimulator | Pivotal | 11 | 480 | CM, PM, RA | WE, CE, NO |