Jacksonville, Florida 32216
519-657-4222
Acclaim Pharma Research Inc. is a Phase I contract research organization dedicated to the management of pharmacokinetic/pharmacodynamic/bioequivalence studies. It is the ideal clinical set-up for the short-term and long-term observation of patients after receiving a pharmaceutical, biotech or natural health product.
Acclaim Pharma Research Inc. offers a state-of-the-art Phase I clinical facility. There are two spacious and self-contained clinics housed within the 10,600 square foot area with a total capacity of 10 ICU beds plus 80 BA/BE beds (total 90 beds). Our facility design includes a separate male/female sleeping area.
Acclaim Pharma clinics operate under Good Clinical Practice Guidelines and strict adherence to the International Conference on Harmonization (ICH) guidelines.
We also offer data entry, data analysis, and statistical analysis along with the writing of final study reports and medical publications.
Client Services
Acclaim Pharma Research's Clinical Facility houses two separate and self-contained clinics with a total capacity of 90 beds. Our facility design includes a separate male/female sleeping area. Acclaim Pharma Research Inc houses state-of-the-art clinic trial site equipment including, refrigerated centrifuge, monitored freezer room, limited access pharmacy room, and EDC. We maintain very high standard in Clinical Research and our studies are conducted with strict adherence to ICH-GCP and GLP regulations. Acclaim operates embodying best clinical practices that are essential to a Phase I clinic.
Acclaim Pharma Research has the expertise in the following areas of product and clinical development: Bioavailability, Bioequivalence, Pharmacokinetics, Specialized SR Studies, and Drug Interaction Studies, First in Human Studies, Special Population, and Pilot Studies.
Our goal is to bring your product to market in the timeframe specified by the sponsor. We make every effort to meet and go beyond the expectations of our clients and regulatory bodies. Timelines and quality are the hallmark of our work.
Acclaim Pharma Client Services staff are experienced in running each project from initial concept and study design, to the final report. Our site works with an independent ethics review board which holds frequent meetings with a fast turnaround time catered to suit the needs of the sponsor.
To arrange a visit to Acclaim Pharma Research, or to discuss outsourcing your next Phase I trial, please contact Dr. Aditya Gupta at 519-657-4222 x277 or email us at: trials@acclaimpharma.com and David Metrillo at 519- 657- 4222 ext 311 or e-mail at dmetrillo@acclaimpharma.com
The services provided by Acclaim Pharma Phase I clinic include:
- First In Human Studies
- Bioequivalence
- Bioavailability
- Pharmacokinetics/Pharmacodynamics (single & multiple dose)
- Drug/drug Interaction
- Drug Metabolism
- PKPD data analysis
Aditya K. Gupta, MD, PhD, MA (Cantab), MBA, MBA/HCM,
FAAD, FRCPC, Medical Investigator
Dr. Gupta is a board certified dermatologist who has extensive
experience in conducting clinical trials. He obtained his medical
degree from the University of Southampton Medical School,
Southampton, U.K, did training in Internal Medicine at the
University of Toronto, Toronto, Canada and subsequently did a
residency in dermatology and clinical trials fellowship from the
University of Michigan, Ann Arbor, MI, USA
Dr. Gupta went on to perform research training at the National Institutes of Health, Bethesda, MD, USA. This was followed by further research in the Department of Dermatology, University of Göteborg and Shalgrenska University Hospital, Göteborg, Sweden where he obtained a Ph.D.
Dr. Gupta is Professor, Division of Dermatology, Department of Medicine, Sunnybrook Health Sciences Center and the University of Toronto, Toronto, Canada. Dr. Gupta has conducted approximately 75 Phase II, III and IV clinical trials and has been a primary investigator at Mediprobe Research Inc. for about 50 of those trials.
He has written over 450 articles and book chapters that have appeared in journals published in the US, Canada, Europe and other countries. Moreover, he is on the Editorial Board/ Advisory Board/ Section Editor of approximately 20 journals.
Dr. Gupta has served on the Dermatology Expert Committee of the United States Pharmacopoeia. He is the Treasurer and Board Member of the Council of Nail Disorders. Dr. Gupta is also on the Board of Directors of the Skin of Color Society.
We maintain a relationship or have members in house with experience and expertise in the following:
- Cardiologist
- Biostatistician
- Dietitian
- PK/ PD Scientist
- Pharmacist
- Phlebotomists
- Quality Assurance/Quality Control Officer
- Security Officer
- Data management & Analysis
- Medical writing and protocol development
- Regulatory Affairs
Scientific Affairs and Project Management
Our expert in pharmacokinetics will develop the Phase I trial protocol, preparing appropriate dosing and blood draws schedules. Sample size estimation will be done based on the study product and the regulatory requirements of the country of submission.
All clinical trials will be submitted to Health Canada (Clinical Trial Application) and to an independent Research Ethic Board before implementation. All 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).
Our medical center has a large subject pool of 1million including large pool of healthy non-smoking subjects; approximately 29,000 students and staff of the University of Western Ontario across from the clinic. Our clinical trials are conducted in adults and children.
Cardiology/Vascular Diseases
Dermatology/Plastic Surgery
Endocrinology
Gastroenterology
Hematology
Immunology/Infectious Diseases
Musculoskeletal
Nephrology/Urology
Neurology
Obstetrics/Gynecology
Oncology
Ophthalmology
Pharmacology/Toxicology
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Rheumatology
Our Facility:
- Custom designed 10,600 sq. ft. clinical trials facility with 2 trial units (one 10-bed ICU unit, and one 80-bed unit) in a fully monitored clinic environment
- Automated data management system
- Monitored freezers (-40°C, -80°C) and fridges (0° to 4°C)
- Refrigerated Centrifuge
- Crash cart equipped with defibrillator/Monitor, Oxygen Tank, Ambu Bag and emergency medications
- 12-lead and rhythm ECG monitors
- Site set-up for the use of medical devices/monitors including IV pumps, Glucometers, ECG testing, etc
- Back-up generator
- Secured medical file and chart storage facilities
- Temperature-monitored secure drug storage room
- Conference rooms for visiting monitors with phone/ fax/ internet access
Our Advantages:
- Expertise in management of bioequivalence studies with wide range of pharmaceutical formulations
- In-house protocol development and data management by expert pharmacokinetics.
- Regulatory submission to Health Canada, FDA
- Use of an independent Ethics Board which provides rapid review
- Automated data management software provides reduced trial times, faster data lock resulting in quality, cost effective solution
- All trials conducted under Good Clinical Practice (GCP) guidelines
- Standard Operating Procedures (SOPs) updated regularly to ensure trials are conducted in a quality driven consistent and efficient manner
- Knowledge in the regulatory requirements for bioequivalence studies and PK trials
- Can accommodate up to three BA/BE studies concurrently
- Central location, with easy access from Highways 401 and 402, and London Airport
- Across from University of Western Ontario with 29,000 students and staff
- Large pool of healthy non-smoking subjects
- Pediatric and geriatric population
- Convenient free parking
- Experience in electronic data capture and management of large databases
Dr. Aditya Gupta
Acclaim Pharma Research, Inc.
1486 Richmond Street, 2nd Floor
London, Ontario N6G2M3
Canada
519-657-4222 ext. 277
519-657-4233 (fax)
trials@acclaimpharma.com