Biovail Contract Research is divided into 5 operating areas each critical to the overall success of each project
The Clinic:
The clinic is dedicated to conducting high quality, regulated and cost effective Bioequivalence and Bioavailability studies. Our newly renovated main facility, plus our secondary clinic site offer 6 fully equipped stand alone clinics for a total of 230 beds. Our flexible design allows us to easily accommodate study designs such as mixed populations, large groups, and controlled substances. Our Phase 1-12 bed hospital unit with its sophisticated monitoring systems can accommodate complex studies in healthy normal individuals and special population groups. Our highly qualified and experienced staff is dedicated to conducting studies with strict adherence to protocol and regulatory standards.
The Lab:
The Bioanalytical Laboratory is equipped with the latest computerized analytical instrumentation to provide the best possible service in Bio analysis. A highly skilled method development group is responsible for developing methods and procedures that will meet the most demanding industry and regulatory requirements. A large number of HPLC's, LCMS and LCMS/MS allows for high through put of study samples and excellent turnaround times for receipt of QA'd analytical data.
Study Operations:
The Study Operations department facilitates the process of a clinical research study from its design through to the issuance of the final report. Our study designs are prepared based on research, use of statistical tables and our own personal experience to ensure appropriate study power. Internally prepared protocols are taken through a rigorous review process prior to presentation to the IRB. The recruiting and medical screening processes ensure entry of appropriate study subjects based on
existing SOP's, regulatory requirements, and individual study protocols.
Our experts prepare a statistical analysis based on data generated by the
analytical lab. If required, safety data can be electronically captured
from the clinic, complied, tabulated and analyzed. The final report is a
clear, comprehensive report-written by scientific writers. Reports conform
to the requirements of the FDA, TPD, European agencies or can be customized
to suit each clients individual requirements either in hard copy volumes or
in an electronic format.
Quality Assurance Department:
The Quality Assurance Department acts as the monitoring and compliance-ensuring unit for all of the operations and procedures conducted at Biovail Contract Research.
Client Services Department:
The Client Services Department is a group of experienced professionals that act as the vital communication link between the client and all internal departments - ensuring each project is expertly managed from initial study concept to issuance of the final report.