Therapeutic Expertise
Orthopedics
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.
Orthopedic Experience
D-TARGET has managed 25 CE mark, IDE and post marketing orthopedic device trials over the last 5 years treating more then 2600 patients. In addition we supported the industry in 21 consulting projects, covering single or special tasks. Details can be found at the end of this document.
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
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 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.
Orthopedic Experience in detail
Indication | Device Type | Study Type | Sites | Patients | Services | Region |
Orthopedics |
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Degenerative Disc Disease | Spinal Implant | IDE | 18 | 480 | Full Service | US |
Bone Material | Pilot | 1 | 20 | CM, MM, PM, RA | NO | |
Bone Fracture/ Repair | Bone Material | Pivotal | 1 | 20 | CM, MM, PM, RA | NO |
Bone Fracture/ Repair Vertebroplasty | Bone Void Filler | Pilot | 1 | 3 | CM, MM, PM, RA | WE |
Cartilage Knee Defect | Cartilage Filler | Pilot | 5 | 120 | Full Service | WE, NA |
Cartilage Defect | Cartilage Repair Material | Pilot | 4 | 50 | CM, MM, PM, RA | WE |
Degenerative Disc Disease | Injectable Disc Nucleus | Pilot | 1 | 16 | CM, MM, PM, RA | WE |
Degenerative Disc Disease | Spinal Implant | Pilot | 3 | 16 | Full Service | WE, NO |
Degenerative Disc Disease | Bilateral Facet-Augmentation System | Pilot | 3 | 32 | CM, PM, RA | WE |
Degenerative Disc Disease | Spinal Implant | Pilot | 3 | 50 | MW | WE |
Degenerative Disc Disease | Injectable Disc Nucleus | Pilot | 6 | 70 | CM, MM, PM, RA | WE |
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 |
Degenerative Disc Disease | Spinal Implant | PMS | 26 | 110 | CM, DM, PM, RA | WE, NO, AF |
Disc Herniation | Posterior Stabilization | Pilot | 8 | 80 | CM, MM, PM, RA | WE, CE, EE |
Herniated Nucleus Pulposus | Injectable Disc Nucleus | Registry | 1 | 200 | BS, DM, MW | WE |
Low Back Pain | Laser | Pilot | 1 | 30 | RC | NA |
Partial Hip Replacement/ Femur Fracture | Acetabular Head | Pilot | 7 | 20 | Full Service | WE |
Meniscus Tear/ Repair | Artificial Meniscus | Pilot | 9 | 50 | Full Service | WE |
Post Discectomy Pain | Spinal Implant- Bonding Material | Pilot | 8 | 54 | CM, MW, PM, RA | WE |
Spinal Stabilization | Spinal Stabilization System | Pilot | 1 | 15 | CM, MM, MW, PM, QA, RA | WE |
Spinal Stabilization | Spinal Implant | PMS | 18 | 268 | BS, DM | WE |
Spinal Stabilization | Posterior Spinal Implant | Pivotal | 5 | 100 | CM, PM, RA | WE, ME |
Spinal Stabilization | Posterior Spinal Implant | Pilot | 6 | 120 | CM, MM, PM, RA | WE, ME |
Vertebral Compression Fractures | Vertebral Body Replacement Device for Maintenance of Disc Height | Pilot | 3 | 10 | BS, DM, MW | WE |
Consulting Projects | Service | Region |
Medical Management for Transdermal Pad used in the Treatment of Lower Back Pain | MM | NA |
Biostatistical Programming Services for Lumbar Disc Regeneration Study | BS, FS | NA |
Clinical Monitoring & Project Management Training | Clinical | Europe |
Clinical Strategy and Regulatory Consulting for Dynamic Stabilization System | Clinical, RA | Europe |
Clinical Strategy and Regulatory Support for Vertebroplasty System | Clinical, RA | Global |
Data Management Support for Spinal Device/ Bonding Material used in Pain Reduction Post Discectomy | DM | WE |
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 |
Paid Feasibility for Spinal Cord Injury Study | SS | Europe |
Quality Assurance Audit for Lumbar Disc Regeneration Study | QA | NA |
Quality Assurance Audit for Lumbar Interspinous Decompression System used in Spinal Fractures | QA | Europe |
Regulatory Consulting/ CE Marking for Cartilage Material in the Treatment of Degenerative Disc Disease | RA | Europe |
Regulatory Support for Bone Void Filler (Design Dossier Compilation for CE marking) | RA | NA |
Regulatory Support and Site Selection for Drainage System used in Total Hip Replacement | RA, SS | Europe |
Regulatory Support and Medical Article Summary for Endorthotic Treatment of Flexible Flat Foot | MW, RA | Global |
Regulatory Support, Quality Assurance and Strategic Consulting for Cartilage Material | Clinical, QA, RA | Europe |
Regulatory Support for Spinal Mesh used in Annulus Soft Tissue Repair | RA | Europe |
Regulatory Support for Spinal Motion Preserving Device | RA | Europe |
Regulatory Support for Spinal Graft | RA | Europe |
Study Start Up for Facet Arthroplasty Study | SS, RA | WE |
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 including 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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