OnSite
Consultant
Services



Data Management Support Services

  • Development of Data Management Plan
  • Development of Data Management Manual
  • Development of Data Quality Management Plan
  • Development of Tables Manual
  • Development of Mock Tables for reports
  • Development of Data Validation Plan
  • Review of any data management document
  • Consultancy on optimizing return on investment through query process
  • Monitoring plan for data queries (80% rule, PROC UNIVARIATE reviews)
  • Interim assessment of data queries 
  • Data base audit
    • Audit plan with random selection of case reports
    • Audit report with process described
    • Errors and observations clearly written
    • Certificate of audit provided

Our team will consider the following:

  • Are you querying the right things?  
  • Are you querying things that you should stop querying?
  • Are there new queries that you should introduce because errors are getting through?  
  • Is the right proportion of queries coming back with changes in information?
  • Are the changes properly documented?
  • Are all data under site signature traceable to the Investigator and accountable by the Investigator?
  • Are there too many changes in the data?
  • Are there changes without signatures or dates?

 

 

Consulting Services | Data Management | Medical Writing | Auditing | Programming
Statistics | Due-Diligence | Seminars | Employment | Contact Us | Home | Admin