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Clinical Pharmacology Unit (CPU)
Accutest is endowed with comprehensive technological and scientific capabilities, including protocol designing, EC approval, regulatory approvals (if any), and conduction of clinical phase of study. Two clinical pharmacology units at Navi-Mumbai with 100 beds, four clinical pharmacology units at Ahmedabad with 163 beds and three clinical pharmacology units at Baroda with 100 beds which are organized to conduct GCP compliant studies.
Each clinical pharmacology unit (CPU) has well defined and adequate areas for following activities
Staging and Screening with separate rooms for one to one consenting
Housing with appropriate facilities for male and female subjects
Dosing
Sample collection & processing
Emergency Ward (ICU) equipped with medicines and modem devices
Pharmacy: IP acceptance, dispensing and storage
Recreation
Medical and Nursing Staff
Cafeteria
All the above said areas are designed as per the flow of man and material. Applicable areas are equipped for handling photo sensitive drugs.
Electronic ECG recording is done for accuracy and data storage. Movable trolleys are used by the bedside during ECG recording.
Volunteer registration is done on the basis of Bio-Metric identification and Inter CRO cross-participation software, which eliminates participation of volunteers within 90 days.
High standard instrumentation such as Deep-Freezers @-20°C & -80°C, temperature controlled centrifuge machines is used.
The clinical team including Principal Investigator, Co-Investigators, Medical Officers, Pathologists, Clinical Research Associates, Nursing Staff, Phlebotomists, Technicians, Custodians, Pharmacists and Dieticians, is qualified, trained and experienced to execute different study designs:
Pilot/ Pivotal Study
Fast/Fed
Cross over, Parallel, Steady State
Drug-Drug Interactions
Add on
Outlier confirmation
Sequential studies
Pharmacodynamic end point studies
Reference scaled BE studies (three way, four way)
Dose Escalation (SAD/MAD), Safety & Tolerability, Dose Ranging and Vaccine studies
Experienced in wide range of Therapeutic categories including clinically critical drugs: cardiovascular, infectious diseases, psychiatric, gynecological, endocrine, neurological, anti-inflammatory, analgesic, gastrointestinal, respiratory, urological and dermatological.
Experienced in Different dosage forms
Solid and Liquid Orals
Nasal Spray/ Inhalers
Injectables (IV/IM)
Patches
Topical medications including creams