Providing efficient and secure biostatistics
Syngene’s clinical data management and biostatistics (CDMB) team provides customized solutions that meet the specific needs of various types of clinical studies. Our clients benefit from Syngene’s advanced systems, standard operating procedures (SOPs), and experienced project personnel that optimize for cost-effective and secure services.
Our tenured scientists are well-versed in the complexities of global regulatory requirements, orchestrating timely delivery while adhering to sponsor and protocol-specific requirements. In the event of any disaster, Syngene’s comprehensive disaster recovery protocol, ensures the integrity of our extensive information systems, enabling the continuity of research projects.
At Syngene, we offer support for bioavailability and bioequivalence (BA/BE) studies, chemistry manufacturing and control (CMC) programs, phase I – IV clinical trials, and in-vivo preclinical development. Additionally, we also offer the following services:
- Data management: Our advanced system provides customized and reliable data management of clinical research data. We implement customized workflow management, design case report forms (CRF), and carry out data capture, double data capture, and electronic data capture. In addition, we conduct discrepancy or query management, and medical coding, and also perform serious-adverse-event reconciliation as per our disaster recovery protocols.
- Biostatistics: Syngene’s team delivers reliable biostatistics analyses that conform to global regulatory standards based on clinical research data. We work on statistical inputs for protocol design, sample size calculation, randomization or blinding techniques, development of statistical analysis plan, development of mock shells, statistical analysis system (SAS) programming for independent validation of table, listing and figures, SAS programming for efficacy development, integrated summaries of safety and efficacy, and statistical report preparation and review. We also assist data safety and monitoring boards (DSMB) and domain specific review boards (DSRB) to conduct interim data review or analysis for regulatory clearances.
- Biostatistical Programming Services: Our team of highly qualified and seasoned programmers offer expertise in biostatistical programming to support clinical development plans. We work on creating mock shells, incorporating randomization codes into clinical database, creating programming specification documents, study data tabulation model (SDTM) development programming, analysis data model (ADaM) dataset programming, statistical analysis data sets programming, pooling of data, creating programs for tables, listings and figures, and Quality checks. We also provide support for data and safety monitoring board (DSMB) related programming activities, interim and final analysis.