27.Apr.2012

OCT is responsible for Data Management and Statistics in Advanced Melanoma Study

OCT will provide clinical data management and statistics services for a small German biotech company

OCT will provide data management and statistics services for a small German biotech company. A full-service OCT data management includes the following:

  • CRF Design for Clinical study
  • Database Design and Programming
  • Site team, CRAs and Sponsor/Project team DM trainings
  • Real-Time Data Entry
  • Data Cleaning
  • Data Coding (using MedDRA, Version 15, and WHO DRUG ATC/DDD Dictionaries)
  • SAE/AE Reconciliation
  • SAS Programming and Validation
  • Statistical Reports

ОСТ Data Management Process in Clinical Study

Investigators Sponsors Database Data Manager SQL Server Application Reports SPSS / SAS Reports

OCT will start with electronic data management system and CRF template development followed by data management trainings for all PIs and study team. Statistical analyses plan will be prepared by OCT data managers to describe in every detail the statistical methodology of planned analyses, of assumptions made in the analyses, and of planned data transformations. The SAP also documents how missing data will be handled, and contains shells for all of data listings, tables and figures.

Web-based data management process will be applied in this advanced melanoma study in 21 patients. All data will be entered directly from study sites into electronic CRFs (eCRFs). Error checking during data entry at the sites will allow early detection and correction of errors including direct checking against source documents.

OCT data managers will perform interim statistical analysis prior to database lock. The statistical Data gathered after a clinical study requires a precise analysis. OCT statistical analyses are performed using industry standard SAS software. After completion of the analysis, our statistician will write a detailed statistical report describing the statistical methods used and a statistical interpretation of the results. Statistical reports display comparisons between treatment groups for specific outcomes and usually consist of summary statistics for each treatment group and assessment of statistical significance.

OCT offers comprehensive clinical data management services on customer friendly business models. Our clients can be assured that study data is being managed properly. Both internal and external audits of our database have verified low error rates. It does not matter if your clinical study requires paper, or web-based data collection, we have the experience, expertise, and tools to manage your data.