Protocol Design
- Protocol preparation group having medical and pharmacy background and experience of conducting clinical studies. They design clinical study protocols in coordination with Project coordinator, biostatistician and panel of consultants(if required).
- Our clinical physicians and consultants work closely to offer scientific inputs for study.
- The designed protocol will be reviewed by PI, Biostatistician, Bioanalytical Investigator & QA before it is shared with sponsor
Subject Recruitment & Screening
- Large volunteer database (More than 39,000 - males and females)
- We recruit from the pool of 9 million population of Pune city & adjoining areas.
- This large pool allows Synapse to recruit volunteers for studies rapidly.
- All subject screening activities are conducted in a separate screening area within the same facility.
Clinical Study and Project Management
- Study Director is appointed for each study by the management. Study director appoints Principal Investigator, Bioanalytical investigator and Biostatistician for each bioequivalence project.
- Each project is managed by the appointed project coordinator who will be responsible for coordinating all study related activities from protocol design to report submission
Bioanalysis
We provide following bioanalytical support with team of qualified analysts:
- Analysis of drug and /or metabolite (s), pro-drugs in biological samples as per study requirements
- Adaptation and revalidation of sponsor’s assay methods
- Method for drug-drug interaction studies
- Chiral analysis
- Analysis of multiple analytes from combination drug products
- Analytical group works into three shifts allowing 24/7 operation of our analytical equipment and ensuring that client’s timelines are always met.
- Online systems capture information with networked temperature monitoring of all refrigerators, deep freezers and drug storage.
- Our goal is to provide the accurate analysis in the shortest possible time while maintaining full compliance with regulatory requirements.
- The lab offers highly selective and sensitive assays of drugs, metabolites in biological fluids.
- QC and QA procedures ensure that our lab produces top quality and credible data with no room for discrepancies.
Capabilities:
- Capacity to analyze approximately 40,000 + samples / month
- 250+ validated methods and continuously developing new methods as per requirements.
- Method transfer or cross validation between instruments & matrices
- Bioanalysis of drug and metabolites in a variety of biological matrices from preclinical and clinical trials
- Ability to develop and validate highly sensitive assays in low pg/mL range
- Ability to develop and validate methods well in advance based on patent expiry and business sense
- Qualified, trained & experienced team of bioanalytical professionals