Putting Science to Work

Biometrics & Clinical Data Management

Clinical Management Data & Biostatistics

Syngene's Clinical Data Management and Biostatistics team provides solutions that are customized to meet the specific needs of each clinical study. Our systems, SOPs and project personnel are equipped to provide cost-effective and secure services. Based on previous experience of dealing with the complexities of global regulatory requirements, our project teams have developed the expertise to deliver projects on time while adhering to sponsor and protocol specific requirements.

Syngene's comprehensive disaster recovery plan is designed to keep its extensive information system intact and ensure continuity of research projects in the event of a disaster/adverse event.

Syngene offers CDMB services to support:

  • BA/BE studies 
  • Phase I-IV clinical trials 
  • CMC programs
  • Preclinical development (In vivo)

Data Management:

  • Case Report Forms (CRF) design 
  • Workflow management 
  • Data capture
  • Double data capture
  • Electronic data capture 
  • Discrepancy/query management 
  • Medical coding 
  • Serious adverse event reconciliation 

Biostatistics:

  • Statistical inputs for protocol design 
  • Sample size calculation 
  • Randomization/blinding
  • SAS coding
  • Statistical analysis 
  • Statistical report preparation
  • Support DSMB/DSRB conduct an interim analysis

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