New Publication in the Journal Monitor (ACRP)

 

Target Health is pleased to announce a new publication entitled “A 21st Century Approach to QA Oversight of Clinical Trial Performance and Clinical Data Integrity (http://www.targethealth.com/PDF/Articles/13498-10_Mitchel.pdf) published in the December edition of Monitor (publication of ACRP). The following is a brief summary:

 

“Monitoring is considered a quality control (QC) process (ongoing activities to assure quality), whereas audits are considered quality assurance (QA). QA procedures are not typically an integral part of a drug development program, but encompass a process that occurs during or after “the fact.“ Thus, it is not uncommon for corrective actions to occur too late to allow for meaningful changes, and for trial managers to spend an inordinate amount of time writing “notes to file“ and performing “crisis management.“ In order to address this issue, a drug development program was initiated using a quality-by-design (QbD) approach, recognizing that (a) change will be difficult to implement and (b) often quality departments are “feared“ and have powerful roles in companies. Paying heed to such concerns, an independent quality expert was assigned to the development team with the mandate to assure proactive and upfront quality planning at all stages of development.“

 

For more information about Target Health contact Warren Pearlson (212-681-2100 ext. 104). For additional information about software tools for paperless clinical trials, please also feel free to contact Dr. Jules T. Mitchel or Ms. Joyce Hays. The Target Health software tools are designed to partner with both CROs and Sponsors. Please visit the Target Health Website

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