Incorporated in 1995, Trial Management Group Inc. (TMG) is Canada's largest GP based site management organization (SMO), exclusively representing 35 investigative sites across Canada. Our GCP trained investigators and coordinators have extensive experience in Phase II-IV clinical trials involving multiple therapeutic indications.

TMG's objective is to effectively collaborate with sponsors and CROs to help ensure clinical trial goals and expectations are met. In particular, our philosophy revolves around three key measures, Time, Quality and Results.

It is well recognized that time is critical in clinical trials. The sooner companies can complete a study, the sooner they can reap the benefits. TMG can help your company meet its timelines in the following areas:

• Rapid site identification and qualification
• Rapid, right first time regulatory documentation completion (centrally coordinated)
• Prompt contract negotiation and completion (one contact for all contracts and budgets)
• Timely patient enrollment (TMG investigators routinely surpass target enrollment deadlines helping companies reach their goals on time)
• Reduced time spent by project managers because of ongoing support from TMG
• Minimal time spent monitoring high quality, professional sites

Likewise, quality data delivery must be the focus of every responsible participant involved in your clinical trials. TMG has the following initiatives in place to support our sites' commitment to quality:

• GCP trained investigators and coordinators
• TMG SOPs at all sites; active SOP training program
• Sponsorship of CCRP accreditation program
• Monthly newsletters that focus on key GCP and study related issues with real life case study examples
• Ongoing liaison with CRAs and/or project managers during the study to encourage feedback on site performance

TMG sites have performed exceptionally well in key trial metrics including screen fail rates, randomization and subject completion rates. Since January 2000, TMG sites have:

• Screened 9600 patients (19% screen failure rate)
• Randomized 7800 patients (127% randomization rate)
• Retained 6700 patients in the study (86% patient retention rate)

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Hypertension Influenza Influenza Vaccine Insomnia Irritable Bowel Syndrome Metabolic Syndrome Migraine Obesity Osteoarthritis Osteoporosis Peripheral Neuropathic Pain Pneumonia Post Herpetic Neuralgia Premature Ejaculation Psoriasis Rheumatoid Arthritis Sinusitis Sinus Headaches Skin Infections Smoking Cessation Women's Health

• Alberta
• British Columbia
• Newfoundland
• Nova Scotia
• Ontario
• Prince Edward Island
• Quebec

Pharma:

Abbott Laboratories Alizyme Altana Amgen Applied Life Sciences AstraZeneca Aventis BioCryst BioSyntech Bayer Biovail Boehringer-Ingelheim Bristol Myers Squibb CombinatoRx Dr. Reddy’s Dynavax Dynogen Eisai Fournier Genentech GlaxoSmithKline ID Biomedical Corporation Janssen Ortho

Lundbeck Merck NicOx Novartis NeurogesX Nuvo Research Nycomed Organon Pfizer Phenomix Purdue Replidyne RibX Roche Sanofi-Aventis Sepracor Solvay Takeda Upsher-Smith Wyeth-Ayerst

CROs:

• ASKA
• Cato
• Covance
• Endpoint Research
• Essential
• Global IQ
• Kendle
• ICON
• I3 Innovus
• MDS
• Parexel
• PPD
• PRA International
• Robarts
• Quintiles

Contact Information

Trial Management Group Inc.
Shawn Keown, General Manager, Operations
60 St. Clair Ave. E., Suite 702
Toronto, Ontario M4T 1N5 Canada
Phone: 416 929 7717
Fax: 416 929 4462
E-mail:

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