Therapeutic Expertise
Surgery
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 200 clinical projects with around 35000 patients.
Surgery Experience
D-TARGET has managed various surgery device trials, including gastroenterology, women`s health and genitourinary indications.
We handled 10 CE mark and post marketing trials over the last 5 years treating with more then 1800 patients. In addition we supported the industry in 10 consulting projects, covering single or special tasks. Details can be found at the end of this document.
Our CRAs
Our fully employed (no freelancers ) CRAs are located in all European countries and the US, speaking the local language and english.
They are purely focused on medical device trials having clinical / nursing backround.
Our CRAs can also provice on site technical support.
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
Our Services:
• Medical Affairs & Strategic Consulting
• Regulatory Affairs including dedicated start up / submission team
• Clinical Trial Management
• Clinical Safety Support
• Data Operations
• Biostatistics
• Medical Writing
• IVRS, IWRS and ePRO
• Quality Assurance
• Compliant with ISO 14155, EU Medical Device Directive and US regulations
Experience in detail
Device Type | Study Type | Sites | Patients | Services | Region | |
Gastroenterology |
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Bowel Obstruction | Surgical Wrap | PMS | 1 | 20 | CM | NA |
Cirrhosis of the Liver | Breath Diagnostic Device | Pivotal/ IDE | 11 | 440 | Full Service | ME, NA |
Colorectal Surgery | Buttress Device | Pilot | 3 | 35 | CM, PM, QA, RA | WE |
Fecal Incontinence | Magnetic Anal Sphincter | Pilot | 2 | 30 | CM, PM, RA | WE |
Fecal Incontinence | Bulking Agent | Pilot | 5 | 99 | CM, PM, QA, RA | WE, NO |
Gastric Bypass Surgery | Buttress Device | Pilot | 1 | 10 | CM, PM, QA, RA | WE |
Gastro-Esophageal Reflux Disease | Reflux Repair Device | Pilot | 8 | 50 | BS, DM | WE, NO |
Gastro-Esophageal Reflux Disease | Magnetic Esophageal Sphincter | Pivotal | 3 | 50 | CM, MM, MW, PM, QA, RA | WE |
Gastro-Esophageal Reflux Disease | Magnetic Esophageal Sphincter | Pivotal | 2 | 30 | CM, PM, RA | WE |
Hernia Repair | Mesh | Registry | 5 | 300 | Full Service | WE |
Genitourinary |
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Contrast-Induced Nephropathy | Renal Device | Pivotal | 20 | 246 | Full Service | NA |
Stress Urinary Incontinence | Sling | Pivotal | 5 | 140 | Full Service | WE |
Urinary Incontinence (in Females) | Sacral Nerve Stimulator | Pilot | 4 | 50 | CM, MM, PM, RA | WE, NO |
Urinary Incontinence (in Males) | Bladder Catheter | Pivotal | 1 | 36 | Full Service | WE |
Urinary Incontinence (in Females) | Spinal Cord Stimulator | Pivotal | 2 | 40 | BS, DM | NA |
Prostate Cancer | Subdermal Implant | 3 | 18 | 98 | Full Service | NA |
Women’s Health |
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Hysterectomy | Electrosurgery Device Used for Tissue Healing | Pilot | 2 | 10 | CM, PM, MM, RA | WE, CE |
Pelvic Floor Repair | Mesh | Pivotal | 9 | 120 | CM, MM, MW, PM, RA | WE |
Consulting Projects | Service | Region |
Statistical Consulting for Medical Devices used in Abdominal Surgeries | BS | NA |
Regulatory Strategy for Cutting and Coagulation Devices used in Abdominal Surgeries | RA | Europe |
Data Management Services for Gastrointestinal Tumor (GIST) Study | FS | NA |
Regulatory Support for Bulking Agent used in the Treatment of Fecal Incontinence | RA | Global |
Regulatory Support for Fecal Incontinence Device Study | RA | Europe |
Site Study Coordinator Services for Magnetic Esophageal Sphincter for GERD | SS | WE |
Vigilance Reporting for Buttress Device | MM | Global |
Clinical Consulting for a Device used in the Treatment of Overactive Bladder | Clinical | Europe |
Regulatory and In-House Support (Data Management and Biostatistical) for Sacral Nerve Stimulator Used in the Treatment of Neurogenic Bladder | RA, BS, DM | WE |
Biostatistical Support for Cutting and Coagulation Devices | BS | NA |
Services |
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BS CM DB DM IT MM MW PM QA RA SS Full Service | Biostatistics Clinical Monitoring & Management Data Safety Monitoring Board Data Management IVRS/ IWRS Medical Management Medical Writing Project Management Quality Assurance Regulatory Affairs Study Start-Up 4 or more services incl. BS, CM, DM & PM | NA WE CE EE AF AP AU CA ME NO SA
| North America Western Europe Central Europe Eastern Europe Africa Asia/Pacific Australasia Central America Middle East Nordics South America
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