Data Management & Biostatistics

Quality Expert to Discuss Data Integrity at DIA Annual Meeting

DURHAM, N.C., June 19, 2017 — Data integrity has been a prime focus of pharmaceutical regulators for two decades now, but the focus is sharpening markedly with issuance of new guidance from multiple regulatory authorities. Sherri Hubby, who leads quality assurance, risk, and compliance at Premier Research, will address this trend and its implications at the Drug Information Association’s Global Annual Meeting in Chicago.

2016 was a banner year for guidance on electronic data, with the FDA and the U.K.’s Medicines & Healthcare Products Regulatory Agency releasing draft guidance for data integrity and the European Medicines Agency issuing its Pharmaceutical Inspection Cooperation Scheme. In her presentation, Applying Data Integrity to Clinical Trials, (part of the June 22 session #410: Of Course My Data Has Integrity … And I Can Prove It), Ms. Hubby will compare the FDA’s new data integrity principles with Title 21 CFR Part 11, the agency rules that in 1997 established the first regulations on electronic records and signatures.

She will also review the MHRA’s data integrity rules and the activities the agency has identified as requiring additional risk controls, along with agency guidance on performing risk assessments.

Premier Research will also be exhibiting at DIA at booth #1307.

About Premier Research

Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, dermatology, medical device, neuroscience, oncology, pediatric, and rare disease. Premier Research operates in 84 countries and employs 1,000 professionals, including a strong international network of clinical monitors and project managers, regulatory, data management, statistical, scientific, and medical experts. They are focused on smart study design for advanced medicines that allow life-changing treatments.