- Bioequivalence Study Execution
- Study Design and Protocol Writing
- Bio-Analytical Method Development and Validation
- Bioassay of drugs
- Study Volunteer Recruitment
- Submission to Ethics Committee for Approvals
- Submission to MoH for approvals
- Trial and Site Management
- Storage of Biological Specimens
- Data Management, PK/PD and Bio-statistical Analysis
- Final Report Write-up
- GLP, GCP, ISO and Quality Assurance Audits
- Study Monitoring
- Dossier Preparation and Submission
- Testing of Drug-abuse
- In-vitro conformation of drug raw materials against pharmacopeia specifications
- Any other need-based service, on demand
The constant vigilance by highly competent quality assurance managers and strict adherence to excellent Standard Operating Procedures ensure the authenticity, quality and excellence of bioequivalence studies conducted at the CBSBR. The CBSBR has quality documentations as crucial step in the process of providing BE reports to sponsor for submission to the national and international regulatory authorities. We have expert GCP and GLP inspectors for routine, study based and annual audits.
EXPERT DEDICATED TEAM
An organized and competent team consists of pharmacists, medical doctors, chemists, statisticians, IT personnel, and quality assurance and business managers, who are all dedicated, competent professionals, committed to excellence. Other staff are associated on part time basis, such as nutritionists, phlebotomists, nurses, etc.
The technical and MIS team is highly qualified and trained from the recognized CRO of Jordan 'Pharmaceutical Research Unit'. The team has also gone through an extensive training under the guidance of trainers from USA, Germany, Canada, Jordan, and Switzerland.
REGULATORY AND DATA MANAGEMENT DEPARTMENT
Regulatory and Data Management Department of CBSBR is well versed with national and international guidelines and requirements of BE studies, especially of US-FDA, EMEA and WHO.
The Regulatory and Data Management dept. is focused to end up with the study report writing for the drug tested, keeping in mind the ethics and values concerned with the human health and life. The process begins with filing of application for new drug approval, continuing with the dossier preparation and submissions, dealing with the hurdles and finally ending up with the approval for conducting the Bioequivalence studies.
Regulatory and Data management department is expert in study protocol writing, processing them through ethical committees and getting approvals from IEC and Ministry of Health Pakistan, WHO, and other international regulatory body.
The R and DM department is also responsible for final Report compilation and report writing and finally archiving of the study based documents and materials. The state-of-the-art computing technology and soft wares are employed in all mathematical and statistical evaluations used in report generation.
Clinical Research Facility (CRF) designed in such a way that maintains GCP-ICH requirements and consists of:
- Volunteers' accommodation facilities (wards)
- Changing room for human subjects
- A recreational area equipped with internet and other facilities
- Drug administration room
- Sample collection rooms
- Sample processing facility with refrigerated centrifuges
- Sample storage facility at -25 and -80 °C
- Well equipped ICU and ambulance
- A self contained kitchen and dining hall
Bio-analytical laboratory complying with GLP and ISO/IEC-17025 standards is equipped with state-of-the-art instruments. All equipments are strictly validated as per IQ/OQ protocols. We have also implemented strict maintenance and calibration programs at the CBSBR.
Instruments include, LC-MS-MS, a series of latest automated HPLCs, Vacuum manifold for solid phase extraction, -80 C freezers, high speed centrifuges, Atomic Absorption, Drying Oven and well equipped wet labs for liquid-liquid extraction. CBSBR has trained and qualified staff to operate these sophisticated equipments.