Saturday, January 16, 2010

QC Provides ROI and Prevents Clinical/Regulatory Submission Pitfalls

The utilization of QC (quality control) pertaining to your clinical/regulatory submission, program, project, data and/or documentation, daily and routinely, is a must and the results are - ROI (return on investment), dramatic reductions in costs, avoidance of pitfalls leading to erroneous data and process and agreed upon timelines are met.

QC objectives, plans and benefits (to mention a few):
  • easy to forecast QC pitfalls when not utilizing QC
  • each data, table, listing, graph, figure and/or document must have a QC plan tailored to catch errors and provide accuracy with current and previously submitted clinical and regulatory submissions and filings
  • easy to forecast areas of significant QC findings and where and how data, statement, format and documentation errors are more likely to be found
  • easy to resolve QC findings
  • easy to track QC findings
  • easy to implement QC findings
  • easy to follow-up the implementation of QC findings throughout your clinical/regulatory submission when dealing with hundreds of thousands of data points
  • easy to demonstrate "streamlining" time, cost, manpower, version, template, effort, data, statement, clear and present presentation, accuracy, consistency pertaining to your data and documentation as a result of QC
  • easy to follow the plan and reap the benefits of quality-controlled data, statement, format, template and documentation pertaining to your clinical/regulatory submission.

Appropriate QC planning and utilization is a must. For example, a waste of QC time is to QC a draft version of a clinical study report, clinical study appendix, a safety narrative, a SAS programmed table, a clinical summary of safety and efficacy, a summary of bioanalytics, a summary of clinical pharmacology, a clinical overview, a subject patient profile, a database listing, a database - to mention a few components, "too early" in the writing and development stages - QC must be performed on the appropriate version, a mature version, a near final version.

The first QC round must be utilized for gross QC (procedure/objectives found in the QC plan) - the second QC round must be focused on QC resolution of the findings, correction, implementation, tracking and finalization.

Two rounds of QC is optimal for most data and documentation.

A third round of QC may be needed if time is tight, the length of the document is too long, for some reason, exceeds the recommended number of pages and/or the document is heavily populated with data. Time, length and data density issues occur due to miss-managed project, writing and SAP (statistical analysis plan) - and are items that must be controlled by the pharma/CRO teams prior to the start of QC - so that QC is effective.

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