Synapse has capability to design, conduct, monitor & report clinical trials of different phases such as Phase II – IV. Trials are conducted & managed by our expertise with accuracy, adhering to quality standards & within specified timelines. We have large data base of qualified, experienced & trained Investigators in various therapeutic segments such as Cardiovascular, Dermatology, Neurology, Oncology, Gastrointestinal, Respiratory, Anti-diabetics and many more.
Our key offerings in Clinical Trials:
➢ Investigator Site Selection
➢ Preparation and Review of Protocol
➢ Preparation and review of clinical trial applications and dossiers
➢ Effective communication with regulatory authorities
➢ Assistance with IEC approval for the studies.
➢ Database of highly skilled, experienced and enthusiastic clinicians and researchers
➢ Site Management Services
➢ Preparation of statistical analysis plan including Mock Tables, Listings and Figures (TLF's)
➢ Sample size calculation, power calculation
➢ SAS programming and Randomization
➢ Statistical programming and data analysis for PK, PK/PD, efficacy, and safety endpoints
➢ Interim and Final statistical analysis
➢ Preparation of clinical study report as per ICH E3 guidelines