Synchron: Leading in clinical trials and medical research services

Synchron is one of the leading organisations in the field of contract research in India. The company aims to meet the specific needs of the clients in clinical registration of new pharmaceutical products and medical devices, from phase I to phase IV clinical trials, strictly adhering to ICH and GCP guidelines. Its research services include bioavailability and bioequivalence, pharmacokinetic and pharmacodynamic studies, dermatopharmacokinetic studies, statistical analysis, data management and pharmacovigilance.

The company offers competitive and high quality clinical trial services to domestic and international pharmaceutical and bio-pharmaceutical companies. Synchron has a wealth of expertise in clinical trial management, pharmacokinetics, data management and statistics (SAS, SAS programming, MedDRA, WHO Dictionary, Oracle), bio-analysis, and pharmacovigilance.

Clinical trial and research services

Pharmacokinetic and pharmacodynamic analysis: Synchron provides an entire spectrum of clinical trial and research services like pharmacokinetic and pharmacodynamic analysis, clinical trial data management, bioavailability and bio-equivalence.

Clinical facility for BA and BE studies

Synchron’s clinical facility (for BA and BE studies) is a 60-bedded state-of-the-art clinical unit based at Ahmedabad with adequate recreation and dining facility for participating volunteers. The bio-analytical facility is equipped with HPLC and LC MS/MS for method development and validation.

The data management facility is equipped with SAS Tools-SAS and EIS, SAS and STAT, SAS and AF, SAS and Graph, and Base SAS MedDRA, WHO Dictionary and Kinetica (Innaphase USA), for pharmacokinetic data modelling.

Analytical laboratory for bioavailability and bio-equivalence studies: Synchron’s Ahmedabad branch has an in-house analytical laboratory equipped with HPLC and LC MS/MS, thus looking after entire bioavailability and bio-equivalence studies. Synchron has many validated bioanalytical methods and our experienced bio-analysis team can rapidly assay the samples for pharmacokinetic evaluation of compounds in various biological matrices. The team at Synchron is experienced in conducting BA and BE studies in almost all the therapeutic areas.

BA and BE studies are prepared for both generic and innovative companies. This full service covers study design, protocol writing, CRF design, Ethics committee review, Selection of subjects, bioassay of drug and metabolite, pharmacokinetic and statistical data evaluations, reporting of study results and archiving of all study related data.

Phase II to phase IV clinical studies and data management

The Bangalore office caters to phase II to phase IV clinical studies and data management. The GCP trained personnel are competent to carry out the above functions that meet the International standards. All the project management activities are carried out in compliance with ICH and GCP guidelines. Synchron functions with a set of detailed Standard Operating Procedures (SOP) for all phase I-IV clinical trials and data management activities. Data management operations are completely validated as per the regulatory requirements.