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Biometrics

Data Management and Biostatistics

Reliable, consistent, and high-quality data is crucial for clinical data management and a critical element of a Clinical trial. Therefore, data management is a vital component of our customer value proposition. CBCC-Vibgyor has a skilled team of Data Management and Biostatistics associates, who are well trained and experienced. By adhering to ICH-GCP guidelines, Standard Operating Procedures, and 21 CFR part 11 compliant systems, our Data Management team provides comprehensive and tailored services right from Protocol Design to Database Lock to generate excellent and superior-quality error-free data to our Sponsor’s utmost satisfaction.

Electronic Data Capture (EDC) facilitates prompt responses. It allows access to the data almost live especially for key trial metrics such as patient enrollment, SAE documentation etc. Ongoing off site monitoring allows immediate checks thereby enhancing the data quality for certain variables. This drastically reduces the queries and time spent during on site monitoring visits. It is easy to identify site issues and can be handled efficiently.

Our strength lies in providing an efficient, cost effective technology solution to our sponsors. Our team will optimize your database working alongside your team to define data requirements, from the CRF design stage through the database lock; enabling integration of external data such as lab data.

Our dedicated data team ensures that the data coming out of the investigative sites is of the highest quality possible. We continuously analyze performance metrics on various Critical Quality aspects to ensure the success of your program.

Our Biometrics Service includes following:

Data Management

  • Development of eCRF/CRF
  • Paper-based or EDC Database Development and set-up
  • Database Validation
  • Data Cleaning and Query Management
  • Remote Data Entry (RDE)
  • CRF Log, Review, and Tracking
  • Double Data Entry and Verification
  • Audit Trail Generation
  • Medical Coding (MeDRA and WHODrug)
  • Expediting accurate, clean, and supportable study data
  • SAE reconciliation
  • Database lock, Transfers, and Archiving – interim, final (required format)

Biostatistics

  • Study Design Development Sample Size Calculations
  • Protocol Statistics
  • Statistical Analysis Plans
  • DSMB and CEC meetings, preparation
  • Statistical Reports
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