Insights

Protecting Patients, Protecting Your Study: The Benefits Of A Well-Run Data Monitoring Committee

Everything rests on having the right Data Monitoring Committee (DMC) in place. A well-run DMC protects patient safety and ensures data integrity. A poorly run one puts patients—and the trial itself—at risk. DMCs are independent groups of experts, typically clinicians and statisticians, who monitor patient safety and sometimes treatment efficacy data during a clinical trial. […]

Quiz: Test Your Knowledge on Depressive Disorders

  References Depression and Other Common Mental Disorders: Global Health Estimates. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO. Prevalence of depression among adults aged 20 and over: United States, 2013–2016. Brody DJ, Pratt LA, Hughes J.  NCHS Data Brief, no 303. Hyattsville, MD: National Center for Health Statistics. 2018. The State Of […]

How A Top-Pharma Client Transformed Its Safety-Reporting Process, Saving $11.2 Million in One Year

Safety reporting is one of the least efficient aspects of clinical trials today. The current approach places a heavy, sometimes unmanageable, burden on sites. Sponsors bombard them with safety notifications, many of which are superfluous or otherwise unnecessary. The entire process is ripe for error, and the consequences can be severe. One mistake can lead […]

Unsustainable and Burdensome: Today’s Safety Reporting Fails Sites, Sponsors and Patients

The way most sponsors and CROs approach safety reporting overburdens sites. Sponsors bombard sites with safety notifications, many of them unnecessary. Sites are overwhelmed to the point they may miss the critical patient-safety information.    Safety reporting is one of the last areas of hidden cost and inefficiency in clinical trials today, costing sponsors millions […]

Post-approval Pharmacovigilance: Support Along the Entire Lifecycle of Your Drug

Patient safety doesn’t end with regulatory approval. In many ways, approval is just the beginning.    Pharmacovigilance activities conducted after regulatory approval are every bit as important as those conducted during clinical trials. Sponsors know this, but many are nevertheless unprepared for just how much work is involved.   A smaller emerging biopharmaceutical company faces […]

Viewing 1 - 10 of 93 articles