Therapeutic Expertise
Cardiology - CRM and EP
D-TARGET has a long tradition in cardiovascular research for medical devices. We have supported the approval of many new devices including ablation systems, CRT devices, transcatheter valves, drug eluting stents, catheters and cardiac assist devices.
D-TARGET has managed 27 cardiology medical device studies treating approximately 22,000 patients within the past three years.
In CRM / Ablation therapy indication we suppported 7 projects treating more then 1700 patients. We have also provided either standalone or consulting services for an additional 11 cardiology projects including Atrial Fibrillation or Cardiac Rhythm Management devices.
Recently, D-TARGET successfully completed the First in Man/CE Mark trial of an innovative ablation catheter. As a result of our performance on the first trial, D-TARGET is currently running an FDA IDE study in the US and Europe for the same sponsor and device.
In addition, we are currently supporting three post marketing trials (two with scientific approach, one European registry) and one pilot trial in Atrial Fibrillation/Cardiac rhythm management. These studies are currently being managed in the following countries: US, Germany, Czech Republic, Netherlands, France, Monaco, Switzerland and the United Kingdom.
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
Cardiology (CRM & EP) Study Experience within past three years
Indication | Phase | Sites | Subjects | Services | Region |
Arrhythmias |
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Atrial Fibrillation (Ablation Catheter) | Pivotal/ IDE | 18 | 300 | Full Service | US, Europe |
Atrial Fibrillation (Ablation Catheter) | Registry | 20 | 300 | Full Service | Europe |
Atrial Fibrillation (Ablation Catheter) | Pilot / CE | 8 | 100 | Full service | Europe |
Ablation Catheter | Pilot / CE | 6 | 60 | CM, PM, Safety, SUM | Europe |
Atrial Fibrillation (Ablation Catheter) | PMS | 3 | 100 | CM, PM, Safety | Europe |
Cardiac Rhythm Management | Pilot | 10 | 100 | Full Service | Europe |
Cardiac Rhythm Management | PMS | 20 | 800 | CM, PM | Europe, Australia, Israel |
Standalone/ Consulting Projects | Service | Region | |||
Arrhythmias |
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| |||
Data Management Support for Ablation Catheter used in the Treatment of Cardiac Arrhythmia | BM | Europe | |||
Medical Writing and Regulatory Support for Ablation Catheter used in the Treatment of Cardiac Arrhythmia | MW, RA | Europe | |||
Medical Writing and Regulatory Support for Cardiac Assist Products used in the Treatment of Cardiac Arrhythmia | MW, RA | Europe | |||
Regulatory Strategy, Quality assurance, Strategic Product Development for Atrial Fibrillation Device | QA, RA | Europe | |||
Regulatory Support/CE Marking for Ablation Catheter used in the Treatment of Cardiac Arrhythmia | RA | Europe | |||
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Services | |||||
BM | Biometrics ( Data Management, Statistics, CRF, IVRS ) | PM | Project management | ||
CM | Clinical Monitoring | FS | Functional Sourcing | ||
RA | Regulatory affairs | SUM | Submissions management | ||
QA | Quality assurance | MW | Medical writing | ||
