Jeevan Scientific Technology Ltd (JSTL) is a clinical contract research organization (CRO) that provides technology-based clinical research solutions. Its capabilities include bioavailability (BA) and bioequivalence (BE) services, clinical trial services, and pharmacovigilance services. BA/BE services consist of clinical services comprising execution of studies on a range of formulations (oral dosage forms, injectable, suspensions and liquids), single ascending dose (SAD) and multiple ascending dose (MAD) studies, and studies in male and female subjects (pre and post-menopausal women); bioanalytical services equipped with automated samplers to accelerate the sample analysis process; pharmacokinetic and bio-statistics, providing statistical analysis, statistical support in regulatory submission, and study design (protocol review, sample size calculation); and glucose clamping, which offers services such as protocol design and consultation, execution of clamp techniques, and clamp data analysis.
Clinical trial services comprise medical writing (protocol development, clinical study reports, and patient safety narratives); clinical trial management (in-house and on-site monitoring management), clinical trial monitoring (risk-based monitoring services, study supply inventory, and source documentation review and data verification), drug safety management, clinical data management (clinical data management plan, discrepancy management, and edit check testing), biostatistics and statistical programming (biostatistical consulting and statistical analysis report), and quality assurance and compliance services focusing on three areas of audit – project, process, and vendor. JSTL pharmacovigilance services include handling individual case safety reports (ICSRs), literature screening and aggregate reports, signal detection activity (SD), risk management plan, and pharmacovigilance system master file (PSMF) for regulatory agencies.