Data Management & Biostatistics

MedPass has full biometrics capabilities using a 21 CFR Part 11 compliant Electronic Data Capture (EDC) with in-house, data managers and biostatisticians highly experienced in processing and analyzing clinical data from all phases of medical device clinical investigations. MedPass is involved from the start of the clinical investigation to ensure that study design and sample size are appropriate and data collection will meet the needs of the planned data analyses while being user friendly for investigational sites.

Throughout the study, effective data management can be a real asset to drive clinical project management. MedPass tracks key information such as protocol deviations, adverse events, missing and inconsistent data. Communication with the sponsor and clinical project team ensures that corrective actions can be taken as necessary in a timely manner.

Data Management process

  • Ecrf/database design
  • eCrf completion
  • Instruction for the sites
  • Edit check programming and validation
  • Data processing and review
  • Medical Coding
  • Query Processing (data Queries, Serious Adverse Events)
  • Quality review of data listings and queries
  • Data tranfers
  • Database lock
  • Study close out activities
  • User administration

Analysis of data is performed by our biostatistics team, in close coordination with data management to ensure clinical data of the highest quality in a timely manner. Services include CRF review, generation of the randomization schedule, statistical analysis plan, interim analysis, generation of Analysis Datasets (ADS), Tables, Listings, and Graphs (TLGs) and the Final Analysis/Statistical Report.