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:

 General Areas of Experience  Specific Areas of Expertise
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: