Data Integrity

EMA Wants to Revise Quality Documents

Some of the European Medicines Agency’s current recommendations on documenting quality standards for investigational medications will soon be out of date, as the Clinical Trials Regulation comes into effect next year. Read More

EMA Issues Guideline on Covariates in Clinical Trials

Drugmakers planning to assign clinical trial participants to a separate arm of the study based on baseline monitoring must report those plans to the European Medicines Agency, including which factors — called covariates — they plan to rely on to make those assignments. Read More