Our Phase 1 Clinical Trial Experience

Since 1975, Biovail Contract Research has successfully completed over 3.000 early phase I clinical trials in healthy, adult human volunteers on more than 400 different chemical entities in all major therapeutic categories. We have experience with the following types of early phase I clinical trials:

First-in-man trials
Dose-ranging studies
Drug-drug interaction studies
Bioavailability studies
Pharmacokinetic studies
Pharmacodynamic studies

Bioequivalence studies
Pilot studies
Clinical equivalence studies
Food-effect studies
In vivo-In vitro correlation studies
Renal impairment studies

We have clinical trial experience in the following therapeutic areas:

Cardiovascular
Psychiatric
Endocrine
Anti-inflammatory
Anti-infectives
Neurological
Analgesic

Gastrointestinal
Anti-allergy
Urological
Anticonvulsant
Dermatological
Antineoplastic
Bronchodilator

If you are interested in obtaining a quote for an upcoming clinical trial from Biovail Contract Research, please contact us.

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Our Medical and Clinical Staff

We have more than 130 experienced clinic and medical staff available to work on your next clinical trial. These include full-time and part-time staff.
Our medical staff comprises of Dr. Paul Tam, who has been our Medical Director and Principal Investigator for more than 15 years, and Dr. Victor Lao, with more than 10 additional sub-investigators.
For each study, the clinical team comprises of highly qualified staff, including the medical staff (MD’s), clinical research associates (CRA), clinical research coordinators (CRC), clinical research coordinator assistants (CRCA), medical assistants/nurses, and technicians.
Ongoing training and development guarantees that the staffs are qualified to perform all procedures.
We have clinic staff who have received CRC certification from established industry organizations, such as the ACRP (Association of Clinical Research Professionals).

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Ensuring Subject Safety

All study protocols are reviewed by the medical director, clinic director, and the clinical research coordinator to ensure subject safety and strict adherence to standards.
Prior to study start, an Ethics Review Board (ERB) reviews the study protocol and consent form that outlines the study and provides explicit details of any known potential side effects. We currently utilize two ERBs.
All studies are designed and conducted in accordance to strict guidelines regulated under the Food & Drug Administration (FDA) in US, the Therapeutics Products Directorate (TPD) in Canada, and the EMEA in Europe.
All adverse events are documented and addressed during clinical trials. Post study requirements include follow up of adverse events. Based on specific study requirements, post-study physical examinations and clinical laboratory testing may also be conducted to ensure subject safety.

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"We have conducted over 3,000 clinical trials in healthy adult volunteers."

Our Clinical Trial Facilities

Biovail Contract Research has two state-of-the-art, conveniently located clinical facilities in Toronto where early clinical trials are conducted. The headquarter clinical facility (Comstock) includes the three Bioavailability/Bioequivalence study clinics, Phase I clinic, administrative offices, sample processing area, treatment room, kitchen, doctor’s office, and pharmacy. The satellite clinical facility includes two Bioavailability/Bioequivalence study clinics and the medical screening area. Together, the two clinical facilities house more than 200 beds in six separate clinics, and are designed to ensure subject comfort and safety.

Phase I Clinic

12 hospital beds in a fully monitored clinic environment
Ambulatory telemetry system
Suction unit/aspirator
12-lead and rhythm ECG monitor
IV pump for medication delivery
Crash Cart equipped with Defibrillator/Monitor, Oxygen Tank, Ambu Bag and Emergency Medications

Five Bioavailability/Bioequivalence Study Clinics

We have one of the largest clinical facilities (>200 beds) in North America dedicated to bioavailability and bioequivalence studies.
Each clinic is completely separate from the others, to ensure confidentiality.
Each clinic contains the dormitory, dosing room, sample collection room, TV area, meal area, washroom (toilet and shower), and nursing station.
We can accommodate five studies concurrently.
We can accommodate long institutionalized studies, up to 31 days.
We can accommodate large studies, up to 130 subjects.
We can accommodate mixed population studies (males and females) and single population studies (male only or female only)

For prospective sponsors, if you are interested in placing your next Phase I trial or Bioequivalence study at Biovail Contract Research, or if you would like to first visit our site in Toronto, please contact us.

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Our State-of-the-Art Clinic Equipment

ECG Machines
Centrifuges
Mercurial Sphygmomanometers
Glucometers for Glucose monitoring
Crash Carts equipped with Defibrillators, Oxygen Tanks, Ambu Bags and Emergency Medications
-25°C Chest Freezers & -70°C Chest Freezers
Validated Computerized Temperature Monitoring System
Master Clocks

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Other Clinic Facility Features

We have an in-house pharmacy, which can accommodate many investigational drug products, including controlled substances, drugs requiring refrigeration, and drugs requiring reconstitution.
We have an in-house kitchen where we can prepare meals for institutionalized studies. We utilize the services of a licensed dietitian for all of our menus.
Our clinics employ swipe-card technology to secure the entryways. We also have 24-hour security monitoring throughout our buildings.