DATA MANAGEMENT & BIOSTATISTICS

Data Management

An effective data management is the principle core for any successful clinical trials. At Brridge Clinical Research, the handling and maintaining of clinical trial data is a major part of our service offering. Our team members have sound knowledge in Medicine background, Biological sciences and also have a good experience in multiple therapeutic areas.

Our team is experienced and exposed in handling both paper and e CRF based studies. More over the team is flexible in adopting to the Sponsor specific tools to manage their data.

The robust SOP’s enable us to be on par with any of the leading players in the industry in terms of Quality deliverables.

Biostatistics

We understand the importance of Statistical Analysis in clinical research and therefore we strive to provide quality services and solutions.

To ensure quality, we employ robust SOPs to practices. All our statistical services are based on ICH – GCP guidelines.Our team of knowledgeable and well experienced Biostatistician and Statistical Programmers are dedicated to deliver quality services across a wide range of therapeutic areas and to all phases of clinical trials by emphasizing on process optimization and accelerate timelines while ensuring quality and research cost reduction.

Some of the key areas of support include:

  •        Power / Sample size estimation
  •        Protocol and SAP preparation
  •        Mock tables and listings
  •        Edit check programming for Data Management team
  •        Analysis dataset generation
  •        Tables, Listings and Graph generation
  •        Statistical Analysis
  •        Interim and Final Report generation
  •        Validation programming and QC of Reports
  •        Integrated Summary of Safety and Efficacy
  •        Statistical Reports

Brridge Clinical Research offers a wide range of services to achieve CDISC compliance.

Some of the key areas of support include:

  •         Data Integration and Data Mapping services for SDTM compliance
  •         SDTM and ADaM compliant dataset preparation
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