SOURCE: Cutting Edge Information

Cutting Edge Information

December 15, 2016 20:08 ET

72% of Pharma Trial Master File (TMF) Groups have a Quality Control Standard Operating Procedure in Place

RESEARCH TRIANGLE PARK, NC--(Marketwired - December 15, 2016) - Standard operating procedures are essential to successful quality control systems within trial master file(TMF) groups, explaining why nearly three-fourths of surveyed pharmaceutical companies have this set-up. SOPs ensure that quality controls stakeholders have evaluated an appropriate number of documents in advance of regulatory auditsor inspections.

The study, Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices, found that teams that have implemented TMF SOPs can be evaluated on a global, US, and country-level (developed markets and emerging markets) basis. In fact, 32% of global teams have a quality control SOP in place, while 26% of US teams have similar procedures. Surprisingly, the study found no discrepancy between developed markets country-level teams and their counterparts in emerging markets; 21% of surveyed teams in each category have a quality control SOP in place.

"Most TMF teams accept the need for quality control SOPs," said Adam Bianchi, senior director of research at Cutting Edge Information. "However, the processes vary across organizations. Companies also consider a random sample to determine the documents that enter formal quality control systems."

Many TMF groups look to standard document lists to determine which materials enter formal QC systems. The largest percentage of all team types, ranging from 59% of global teams and 80% of US teams surveyed, report using these lists for sponsor-level documents.

Trial Master File Management: Uphold Documentation Processes to Safeguard Good Clinical Practices, available at http://www.cuttingedgeinfo.com/research/clinical-development/trial-master-file/, guides clinical executives through trial master file management practices. Report highlights include:

  • Best practice recommendations and projected costs associated with implementing an eTMF platform
  • Data on dedicated trial master file teams' staffing levels and necessary training structures
  • Metrics detailing clinical trial master file quality control processes, including the number and timing of checks performed on site- and sponsor-level documents

For more information about clinical trial master file management, please visit: http://www.cuttingedgeinfo.com/research/clinical-development/ .

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