Data Management Biostatistics

DATA MANAGEMENT
& BIOSTATISTCS

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

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 basic foundation for robust clinical databases that enable reliable statistical analysis and reporting.

Our Data Management and Biostatics division work hand-in-hand with the Clinical Trials Management teams to leverage the expertise of both effectively.
The 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. 

DATA MANAGEMENT SERVICES INCLUDE:

  • Electronic Data Capture (EDC): from selection to activation
  • Study-specific Data Validation Plan (DVP) development
  • User Acceptance Testing (UAT)
  • Data Management Plan (DMP) development and revision
  • CRF completion Guidelines (CCG) development
  • Provision of reports / trackers
  • Ongoing data review and query management
  • Export, post-process and delivery of clinical study data
  • Database lock Coordination

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

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.

We have experience in different types of trials, including drug, medical device, and non-interventional studies. We guarantee full transparency and close contact enabling you at any point, a complete overview of data and interim results. Our biostatisticians bring 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.

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