Services / Clinical Unit

Our Phase I unit Services

Acclaim Pharma Research Inc. provides these services:

• General consulting with pharmaceutical companies for Phase I-IV
• Bioavailability studies with oral medications and transdermal delivery
• Bioequivalence trials for submission in Canada , the US or abroad
• In-house clinical trials with pharmaceutical, biotech, and natural health products
• Bioequivalence studies with topical corticosteroids
• Safety and tolerability studies
• Skin sensitization and irritation studies
• Adherence to Good Clinical Practices (GCP), International Conference on Harmonization
  Guidelines (ICH), and regulatory guidelines in conducting clinical trials in Canada and the U.S.A.
• Development of Phase I-IV trials, writing study protocols and implementing a clinical program in clinical centers in Canada , sample size estimation and data management
• Independent Research Ethics Board with a short turnaround time
• Development of study protocols, consent forms and case report forms
• Statistical analysis and final report writing
• Publications and presentations at scientific meetings

Clinical unit

Our Facility

• A custom designed 10,600 sq. ft Phase I unit
• Two clinics dedicated for bioequivalence studies with a total of 90 beds with separate dormitory for male and female subjects
• A 10 bed first-in-human clinic
• Large pool of healthy non-smoking subjects
• Two large clinic areas with wide TV screen with cable television
• Wireless internet service
• EKG with internet connection for rapid evaluation by a cardiologist
• Catered food
• Restricted area for drug storage in a temperature-controlled environment
• Conference rooms for visiting monitors with phone/fax/internet access
• Security guard on duty during overnight stays
• Secured medical charts and regulatory documents storage room
• Dedicated, thermostat controlled and secured drug storage room
• Monitored freezers (-80°C, -20°C) and fridges (4°C)
• Refrigerated high-capacity centrifuges
• Boardroom for meetings with clients
• Back-up generator

Clinical team

To meet your clinical trial needs, our team includes:

• Dermatologist
• Cardiologist
• Biostatistician
• Experienced clinical research staff
• Nurses and phlebotomists
• Quality Assurance officer
• A large subject pool of 1 million in London and surrounding area with approximately 29,000 students and staff of the University of Western Ontario located near the clinic.

Scientific Affairs and Project Management

Our expert in pharmacokinetics will develop the bioequivalence trial by preparing the schedule of blood draws and estimating the sample size of subjects based on the study product and the regulatory requirements of the country of submission.

The studies are conducted according to Good Clinical Practices and the regulatory guidelines of the Therapeutic Products Branch (TPD) of Health Canada and the International Conference on Harmonization (ICH).

The clinical trials will be submitted to Health Canada (Clinical Trial Application) and to an independent Research Ethic Board before implementation.

For further information please contact Dr. A. Gupta at (519) 657-4222 Ext. 277.