Bio Scientific Research Laboratories (I) Pvt. Ltd is based at Dahisar (E), in the western suburbs of Mumbai, the financial and Medical capital of India, is a self-managed and self-owned research unit.
Bio Scientific is a full service clinical research organization (CRO) with a core strength in BA/BE & PKA studies in compliance with GCP and GLP (Good laboratory Practice) and other applicable guidelines and regulations.
BIOSCIENTIFIC has a substantial subject bank of around 2000 volunteers with 28 bedded clinical facilities with features like ICU, & Clinical care facilities. The bioanalytical facility is supported by 1 LCMS/MS, 6 HPLC with UV, Fluorescence and PDA detectors, with qualified and well trained scientists for integrated data generation.
The contract research facility is equipped to serve global requirement with following facilities.
| Clinical Pharmacological Unit (CPU) equipped with 28 beds, fully air-conditioned, separate six counter phlebotomy room, independent processing laboratory, well equipped in-house ICU, library, recreation area. | ||
| Custom designed biometric subject registration databank of around 2000 subjects, aesthetic subject staging area and physical examination room. In-house cafeteria with sufficient sitting capacity. | ||
| Bio-analytical Laboratory equipped with top of the line highly sensitive LCMSMS, and fully automated LC systems, solid phase extraction units, freeze drying low volume vacuum evaporation unit. | ||
| Sufficient sample storage facility at required temperature. | ||
| All systems with UPS and Generator backup. | ||
| Overall independent Quality Assurance department to monitor trial related activities, training of staff, periodic audits, system qualifications etc. | ||
| Fire extinguishers are installed on each floor to ensure the safety of the subjects as well as the entire Bioscientific Team. | ||
| Analysts working in analytical labs are provided head gear, hand glove, eye gear and masks to ensure maximum safety. | ||
We undertake studies include fed, fasted and Pharmacodynamic studies to submit data for approval of various regulatory authorities.
We have WinNolin (5.0.1) software for calculation of PK parameters & sas (9.1.3), SPSS (15.0) for statistical calculation. The statistically evaluated data is compiled and finally the report is designed as per the requirement of the authorities.
Our independent QA team is capable of preparing and evaluating SOPs, Protocols ands project report.
With independent QA team, strict adherence to SOPs and Protocols, secure data management, superior management skills and technical competence, we can assure timely delivery of quality results in cost effective manner.
We have developed a reputation for delivering high quality, innovative and cost-effective solutions.
We assure maximum job satisfaction and total secrecy, which cannot be assured in other large scale corporate-owned bodies that treat medical research as 'one of its many activities'.
Repeat business from our clients is our greatest strength.
