DATA MANAGEMENT
& BIOSTATISTCS

MEANINGFUL DATA MEANS BETTER AND FASTER STRATEGIC, SCIENTIFIC AND MARKETING DECISIONS

Our Data Management and Biostatistics capabilities, knowledge and expertise fuel our ability to properly manage clinical trials, enabling our team to plan, analyze, correlate and integrate all your data to attain critical results and insights. Our Data Management and Biostatics division work handin- hand with the Clinical Trials Management teams to leverage the expertise of both effectively. Data integrity and data quality are the most fundamental objectives of Good Clinical Practice in clinical research and go well beyond data collection. These data verification and processing processes are the basis foundation for robust clinical databases that enable reliable statistical analysis and reporting.

DATA MANAGEMENT SERVICES INCLUDE:

  • Case Report Form (CRF) development, design and review to assure data recorded supports protocol objectives
  • Electronic data capture (EDC) development via electronic case report form (eCRF) platforms to collect, review and verify clinical trial data easily, efficiently and safely
  • Support and preparation of randomization
  • Electronic randomization system
  • Data Validation Plan
  • Data management plan (DMP)
  • Edit checks testing
  • Ongoing data review and query management
  • Customized status reports/trackers
  • Paper CRFs
  • Database design for paper CRF
  • Data entry, including double data entry verification for paper CRF
  • Database lock; interim & final

GCP statistician is adept at analyzing clinical trial data and statistical analysis to deliver high quality statistical reports. We have experience in different types of trials, including drug development studies, medical device studies, and non-interventional studies. We comply with ICH GCP E9 guideline, as well as our own SOPs or those of our clients. We guarantee full transparency and close contact so at any point, you have a complete overview of data and interim results. Our biostatistician brings a deep understanding of the underlying science involved in your trials, and can provide valuable input in the study design and planning. This helps accelerate decision-making and reduces risks.

BIOSTATISTICS SERVICES INCLUDE:

  • Study design and statistical considerations
  • Sample size and power calculations
  • Statistical Analysis Plan (SAP)
  • Interim and final statistical analysis of clinical study data
  • Statistical reports
  • Listing tables
  • Statistical sections of clinical study reports
  • Collaborate with medical writers and clinical scientists to ensure appropriate interpretation of quantitative results
  • Support for manuscripts and abstracts
  • Support for posters and slides of oral presentations presented in professional conferences
  • Medical coding

SCALABLE AND SECURE

We deliver services in several widely accepted electronic data capture (EDC) environments. We work closely with our clients to determine specific EDC requirements to customize implementation. The EDC platform we use is scalable to accommodate custom offerings to suit your trial’s data and processing needs. All systems we are using are fully compatible, fully validated, 21 CFR Part 11 and EU Annex 11 compliant, as well as CDISC, HIPAA and GDPR compliant.

ENDPOINT DRIVEN DESIGN

By beginning with the clinical endpoints in mind, we produce highly efficient data solutions that deliver expedited, high-quality reporting and excellent interpretation.

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