US Experience
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.
US Experience
D-TARGET has managed 19 US projects over the last 10 years involving more then 6300 patients. In addition we supported the industry in 24 consulting projects, covering single or special tasks. Details can be found at the end of this document.
Currently we are working on 4 IDE projects in the US. Two with start up companies and the others with major multinationals. Besides that we are currently consulting a world market leading company in setting up their systems for the first US IDE trial, that we will support later as well, when started.
Indication | Device Type | Study Type | Sites | Patients | Services | Region |
Orthopedics - DDD | Disc replacement device | IDE | 18 | 490 | Full service | NA |
Ophtalmology | Intraocular pressure measuring device | IDE | 1 | 30 | CM, PM, SS | NA |
Electrophysiology | Ablation Catheter | Pivotal / IDE | 22 | 300 | Full Serivce | NA, WE |
Respiratory – Ventilation of neonates | Ventilator | IDE | 15 | 450 | Full serivce | NA |
Staff
VP Regulatory
Our Philadelphia based VP of regulatory, Charlene Sanders, MD has worked for the FDA before.
Project Manager
Barbara Cox, our Boston based Senior PM has long experience with US device trials and the FDA.
In the table below we summarized her specific experience so far :
| Pre-IDE | PMA Status | Pre-IDE Mtg | Panel |
Trials Worked on | ||||
| 15 |
| 13 | 4 |
Devices: |
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Vascular stent / graft | 3 | 2 | 2 | 1 |
Cardiac stent | 3 | 2 | 3 | 1 |
Embolic Protection Device (SVG or Carotid) | 3 | 2 | 2 | 1 |
Bifurcation Stent | 2 | 1 | 2 |
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Percutaneous Heart Valve | 2 | 1 | 2 |
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Total Occlusion device | 1 | 1 |
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Left Ventricular Assist Device (LVAD) | 1 | 1 | 1 | 1 |
Anti-restenosis drug given in PCI setting | 1 | iiB |
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Dialysis graft | 1 | 1 |
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Gene Tx | 2 | 1 | 1 |
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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, 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
Previous US Experience in detail
Device Type | Study Type | Sites | Patients | Services | Region | |
Analgesia |
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Dysmenorrhea | Transdermal Tape | Pilot | 1 | 11 | RC | NA |
Fibromyalgia | Transcranial Magnetic Stimulator | 2 | 1 | 30 | RC | NA |
Pain Tolerance | Electroporation Device | 1 | 1 | 11 | RC | NA |
Cardiovascular |
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Atrial Fibrillation | Ablation Catheter | Pivotal/ IDE | 18 | 240 | Full Service | WE, CE, NA |
Atrial Septal Defect | PFO Closure Device | Registry | 15 | 250 | CM, MM, PM, RA | NA, WE |
Dermatology |
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Chronic Venous Insufficiency Leg Ulcers | Wound Dressing | PMS | 30 | 120 | IT | WE, NO, NA |
Foot Ulcers/ Wound Healing | Negative Pressure Wound Therapy System | PMS | 2 | 20 | RC | NA |
Nasolabial Folds | Cosmetic Filler | PMS | 3 | 75 | DM | NA |
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 |
Genitourinary |
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Contrast-Induced Nephropathy | Renal Device | Pivotal | 20 | 246 | Full Service | NA |
Urinary Incontinence (in Females) | Spinal Cord Stimulator | Pivotal | 2 | 40 | BS, DM | NA |
Oncology |
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Malignant Glioma | Chemotherapy Releasing Implant | PMS (Registry) | 220 | 4,400 | SS | NA |
Prostate Cancer | Subdermal Implant | 3 | 18 | 98 | Full Service | NA |
Ophthalmology |
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Glaucoma | Contact Lens-Based Device | Pivotal | 1 | 40 | CM, MM, PM | NA |
Orthopedics |
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Cartilage Filler | Pilot | 5 | 120 | Full Service | WE, NA | |
Degenerative Disc Disease | Synthetic Bone Substitute | Pivotal | 8 | 100 | BS, DM, MW, PM, SS | WE |
Degenerative Disc Disease | Spinal Implant | Pivotal/IDE | 3 | 100 | MM, RA | WE |
Low Back Pain | Laser | Pilot | 1 | 30 | RC | NA |
Consulting Projects | Service | Region |
Analgesia |
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Ad Hoc Statistical Consulting for Medical Devices used in Abdominal Surgeries | BS | NA |
Medical Management for Transdermal Pad used in the Treatment of Lower Back Pain | MM | NA |
Dental |
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QA and Regulatory support for CE/IDE study | RA, QA | WE, US |
Dermatology |
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CTA Submission, IMPD Preparation, IND Maintenance for Anti-Infective Topical Sponge used in the Treatment of Lower Extremity Skin Ulcers | RA | NA |
Regulatory Support for Device in the Treatment of Diabetic Foot Ulcers | RA | NA |
Gastroenterology |
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Data Management Services for Gastrointestinal Tumor (GIST) Study | FS | NA |
Vigilance Reporting for Buttress Device | MM | Global |
Ophthalmology |
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Critical Literature Review for Intraocular lens | RA | Global |
Critical Literature Review for Intraocular Pressure Monitor | RA | Global |
Medical Writing Services for Optical Coherence Tomography Device | MW | Global |
Orthopedics |
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Biostatistical Programming Services for Lumbar Disc Regeneration Study | BS, FS | NA |
Clinical Strategy and Regulatory Support for Vertebroplasty System | Clinical, RA | Global |
Medical Article Summarizing for Bioabsorbable Flat Foot Implant | MW | Global |
Medical Article Summarizing for European Autologous Chondrocyte Implantation | MW | Global |
Medical Article Summarizing for Knee Revision Device | MW | Global |
Medical Article Summarizing for Knee Revision Device | MW | Global |
Medical Article Summarizing for Knee Revision Device | MW | Global |
Quality Assurance Audit for Lumbar Disc Regeneration Study | QA | NA |
Regulatory Support for Bone Void Filler (Design Dossier Compilation for CE marking) | RA | NA |
Regulatory Support and Medical Article Summary for Endorthotic Treatment of Flexible Flat Foot | MW, RA | Global |
Other |
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Biostatistical Support for Cutting and Coagulation Devices | BS | NA |
General Regulatory Support in a Wide Range of Indications for Global Medical Device Company | RA | Global |
Regulatory Support, Quality Assurance and Strategic Consulting for Lipid Mixture and Dispenser Vial used in the Treatment of Oral Mucositis, Stomatitis, etc. | Clinical, QA, RA | Global |
Systems Audit for Cochlear Implant Device used in the Treatment of Hearing Loss | QA | Global |
Services |
| Regions | |
BS CM DB DM FS IT MM MW PM QA RC RA SS Full Service | Biostatistics Clinical Monitoring & Management Data Safety Monitoring Board Data Management Functional Sourcing IVRS/ IWRS Medical Management Medical Writing Project Management Quality Assurance Research Centers 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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