clinical trials

Testing new treatments on patients with life threatening diseases requires immediate understanding of whether the treatment helps or harms. Data Safety Monitoring Boards (DSMB) provide this critical oversight. Proper auditing of these boards ensures trial integrity and patient safety. The Stakes The Challenge A DSMB requires clear rules documented in a DSMB Charter. This defines […]

At a time when the world is transitioning from the mandatory HCP (healthcare professional) reporting, we have a fantastic pilot initiative from the FDA, for empowering consumer/patient reporting. Project Patient Voice is an online platform for patients and caregivers, along with their healthcare providers to look at patient-reported symptom data collected from cancer clinical trials. […]

At a time when the whole world is looking forward to the COVID vaccine, the million-dollar question is obviously how billions of people will get immunized. At the same, time, the billion-dollar question is, how are Pharmacovigilance activities going to be managed if the Vaccine hopes really materialize? In a country like India, where Pharmacovigilance […]