• Pamela Nelson, RN

Lack of Quality Program Impacts Safety and Reliable Data

Desired Outcome Continuous Quality Improvement is to ensure that improvement is continuous, quality is maintained and every opportunity to identify and assess problems is utilized.

However, the real world, QI is expensive. Many companies participate in QI programs because of federal/ regulatory mandates and only to the limits of the required measures. Companies that seek QI programs for improved status in the marketplace, setting of trends an for good measure find that QI is an every evolving process that takes dedication and continuous efforts to identify issues and make the necessary improvements and study then do it all over again.

Benefits of a quality plan for clinical projects

The quality program has its foundation in ICH E6 Good Clinical Practice (GCP) and meets applicable regulatory requirements for overseeing the quality of study conduct to produce study data that is accurate and credible. A quality program incorporates the continuous evaluation and monitoring of the sponsor, investigator, investigational product and vendors.

How can we help?

Once the key issues have been identified, Bracane works with clients to develop work streams that will simplify the quality program and generate key areas that must be done regarding safety. We collaborate with clients to identify areas to focus their oversight time and what areas can be “automated” to generate information needed with less burden on current staffing. For more information about a quality program development contact us at mail@bracaneco.com or call us at 888-568-4271.


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