Life Sciences

Coming Regulatory Changes: Are You Ready?

The safety and pharmacovigilance landscape is changingrapidly. New global standards forregulatory reporting – E2B(R3), eVAERS, eMDR, and IDMP – represent some...

The safety and pharmacovigilance landscape is changingrapidly. New global standards forregulatory reporting – E2B(R3), eVAERS, eMDR, and IDMP – represent some of themost significant changes that the industry has seen in over a decade. Notsurprisingly, implementing them requires planning and preparation from both safetyand IT organizations. Global vs. RegionalRequirements The new standards are adapted to the modern needs ofregulators and industry, as they offer better...

The safety and pharmacovigilance landscape is changingrapidly. New global standards forregulatory reporting – E2B(R3), eVAERS, eMDR, and IDMP – represent some of themost significant changes that...

The Journey to Clinical Data Management v3.0 – Disruption Is Coming

Do you remember the old paper case report form (CRF)? Iremember working on an oncology trial. It was ‘massive’. It was massive becausethe CRF was 300 pages...

Do you remember the old paper case report form (CRF)? Iremember working on an oncology trial. It was ‘massive’. It was massive becausethe CRF was 300 pages long, in a binder you could barely lift with one hand, andthere were 300 subjects. Let’s say, on average, there were 30 fields per page, whichwould equate to about three million data points collected over a five yearclinical trial. We thought of this as a large trial, and yet from a dataperspective, it could easily be...

Do you remember the old paper case report form (CRF)? Iremember working on an oncology trial. It was ‘massive’. It was massive becausethe CRF was 300 pages long, in a binder you could barely lift with...

Cost & Quality

Reformed accountant alert! Decades ago, I studied to be an accountant. Why? Because my Alma Mater told me to be a good healthcare administrator, Ineeded to have...

Reformed accountant alert! Decades ago, I studied to be an accountant. Why? Because my Alma Mater told me to be a good healthcare administrator, Ineeded to have a financial/numbers training. I could pick Economics, Finance orAccounting. I called my family and adultfriends for advice. (Those in the samplegroup were all CPAs.) And, surprise, theirunanimous opinion was for me to major in Accounting. I survived after four and one half years. I still have thethird edition of Keso...

Reformed accountant alert! Decades ago, I studied to be an accountant. Why? Because my Alma Mater told me to be a good healthcare administrator, Ineeded to have a financial/numbers training. I could...