Our biometric department is fully compliant for 21 CFR Part 11 and has capability to deliver extensive clinical data management and biostatistics projects. Our team ensures successful high quality data delivery by keeping your clinical development program on schedule throughout. Our team remains involved at every stage of data management and works closely with study sites to generate clean datasets with total quality management. We offer a wide range of bio-statistical services from database designing to delivery of fully compliant statistical analysis report. Our team comprises of data management executive, data entry operator, data manager, biostatisticians, programmers and medical coder along with internal data quality control executives.

Data Management

Our data management team can manage multi-center, multi-country studies in both electronic and paper based format. We are specialized in managing the following Data Management activities:

  1. Paper CRF/eCRF Development and Database Design
  2. Data Management Plan
  3. Data Entry, Verification and Validation
  4. Double Data Entry (paper CRF)
  5. Coding in MedDRA and WHO DD
  6. Query Resolution and Database lock
  7. Design Safety Database
  8. SAE Reconciliation
  9. Electronic Data Integration
  10. Customized Data Listings

Biostatistics and Programming

Our Biostatistics and Programming Team can manage complex studies by performing in-depth analysis and interpretation of data in different therapeutic areas. We are specialized in managing the following Biostatistics and Programming activities:

  1. Statistical Input in Protocol
  2. Determination of Primary and Secondary Endpoints
  3. Sample Size Calculation
  4. Preparation of Randomization Plan
  5. Input in CRF and eCRF Design
  6. Preparation of Statistical Analysis Plan
  7. Statistical and SAS programming
  8. Preparation of Statistical Tables, Graphs and Listings
  9. Preparation of Statistical Reports