SERVICES / Phase II-IV Clinical Trials
Our Phase II-IV Services
Mediprobe Research provides these services:
- General consulting with pharmaceutical companies for Phase II-IV studies in the field of dermatology
- Development of Phase II-IV trials, study protocols, sample size estimation, data management, final reports and manuscripts
- Conduct of Phase II-IV clinical trials in dermatology
- In-house clinical trials in a 52-bed Phase I clinical unit
- Bioequivalence studies with topical corticosteroids
- Safety and tolerability studies
- Regulatory submissions to Health Canada and to Research Ethics Boards
- Quality of Life Research, Questionnaire Development
- 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.
- In-house management of long-term Phase II-IV clinical trials in patients with dermatological conditions
- Independent Research Ethics Board with a short turnaround time
- Publications and presentations at scientific meetings
Clinical Team
- To meet your clinical trial needs, our team includes:
- Full time dermatologist with over 400 publications
- Over 21 years of pharmaceutical experience in conducting over 80 phase II-IV trials in North America and in Europe and 570 Phase I bioequivalence studies in North-America
- Experienced clinical research staff of 15
Scientific Affairs and Project Management
Our experts in clinical research will develop the study protocol and estimate the sample size of subjects.
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.
Dr. Gupta is your client service contact at Mediprobe Research who will assist you in getting your projects done from the beginning until the end. Dr. Gupta can be reached at (519) 657-4222 Ext. 277. |
