Biometrics

Data Management

Clinical trial success is dependent upon the quality and integrity of the data collected during the clinical trial. Our experience with fully-compliant, state of the art clinical data systems allows us to develop intuitive customized data management systems to meet the specific needs of your clinical trial.  Using documented repeatable processes; BBA will provide you with clean data faster, without compromising quality.  Our in-house data management staff has a collective experience of greater than 10 years in the industry will handle all data collected throughout your clinical trial. Your data are stored securely and processed in compliance with 21 CFR Part 11 requirements.

Our clinical data management services feature:

  • Full service data management services
  • Electronic Data Capture (EDC) systems
  • Electronic Case Report Form (eCRF) design, specifications, and completion guidelines
  • Standard or customized database design and development
  • Query management and data quality audits
  • Automatic edit checks to ensure data integrity
  • Routine administrative reporting throughout the study
  • Delivery of clean data files and comprehensive documentation
  • Integration with third party vendors, core labs, imaging, etc.
  • Database lock and archival

 

Biostatistics & SAS Programming

Our biostatisticians provide trial design consultation, statistical methodology recommendations, programming expertise, and reporting accuracy necessary to deliver your trial outcomes in a timely fashion. Our team’s in-depth understanding of regulatory and clinical requirements play a critical role in the application of statistical and research methodological principles for the design, execution and analysis of clinical trials.  Our experienced team of biostatisticians will work closely with the data management team to implement best practices to ensure clean analyzable data.  Data analysis is performed using industry-standard software, ensuring that every phase of your trial is correctly focused for maximum results.

Our team of biostatisticians works closely with Sponsors to develop the most appropriate statistical methodology for your trial, including Bayesian, Non-Bayesian, and Adaptive designs.

BBA provides a variety of biostatistics support for all phases of pre-clinical studies and clinical trials, including:

  • Pre-clinical and clinical program consultation
  • Sample size analysis and justification
  • Statistical Analysis Plans (SAP) and protocol design consultation
  • Randomization schemes
  • Data Monitoring Committee (DMC) statistical report generation
  • Generation of statistical summary tables, graphs and reports using industry standard software for regulatory submissions, presentations, and publications
  • Interim and final statistical analysis and reporting, including safety and ad hoc reporting for clients

Our experienced teams provide integrated and efficient processes to capture and analyze your data allowing you to demonstrate safety and efficacy with confidence.

We are delighted to have worked with a company like BBA that offered us the full spectrum of clinical and data management services, with an integrated approach to study design, data management, statistical analysis and report generation. BBA’s team of industry leading experts was committed to servicing our needs and delivered high-quality results.
— Barbara S. Lindsay, Vice President at Benvenue Medical, Inc.

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