Clinical Trial Implementation Our clinical research team provides clients with clinical trial management and consulting services, including the design and management of highly challenging clinical trials. The clinical team specializes in high-profile and new technology trials, involving complex and innovative study designs. We optimize trial execution in the US, Canada and Europe through the use of a proprietary in-house clinical trial management system (CTMS), effective application of electronic data capture (EDC), and creative trial-management strategies. Our clinical study team has over 20 years of industry experience, including more than 10 years experience in innovative R&D planning, as well as clinical trial design services, implementation and management support. We have a strong client base of over 100 biotechnology, pharmaceutical, medical device and early stage start-up companies, of which more than 30 are recurring clients. We have completed more than 100 clinical projects in all phases of clinical development, implementing a wide variety of study designs. We have a broad and in-depth therapeutic area background with a focus on the following major medical specialties: inflammatory, infectious and rare diseases. In addition, we have experience in the following areas:
| Inflammation |
Inflammatory Bowel Disease, Rheumatoid Arthritis, Ischemia Reperfusion Syndrome, Aspiration Pneumonitis, trauma, transplantation (hematological, stem cells and solid organs), Idiopathic Pulmonary Fibrosis, ARDS |
| Infectious Diseases |
Sepsis, Meningococcal Disease, HIV, antibiotics, vaccines |
| Endocrinology |
Diabetes, Diabetic Neuropathy, growth hormone deficiencies, Menopause |
| Cardiovascular |
Stents, other interventional cardiology, Heart Failure, Hypertension, DVT, Cardiopulmonary Bypass |
| Bone |
Osteoporosis, Arthritis |
| Oncology |
BMT, Stem cell transplantation, GVHD, platelet preservation, Melanoma (gene therapy), Glioma’s, prostate, gynecology / ovarian, other solid tumors |
| CNS |
Autism, Alzheimer’s, CNS tumors, Schizophrenia |
| Devices |
Stents |
| Imaging |
Pulmonary Ventilation Imaging |
| Allergic diseases |
Asthma, food allergies |
| Pulmonary |
Asthma, Pulmonary Embolism |
| General |
Phase I healthy volunteer, drug interaction and food interaction studies |
| Rare Diseases |
Lysosomal storage diseases, Cockayne Syndrome |
| Urology |
Incontinence, erectile dysfunction, premature ejaculation, male contraception |
| Ophthalmology |
Macular Degeneration, Uveitis |
| Dermatology |
Wound healing (diabetic, venous stasis and pressure ulcers), Psoriasis | Clinical Trial Management Core Services:
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