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Life Sciences

When Good Data Goes Bad by Srinivas Karri

Recently, the FDA published an article describing a notification it had issued to a contract research organization (CRO). The notification required certain...

Recently, the FDA published an article describing a notification it had issued to a contract research organization (CRO). The notification required certain bioequivalence studies to be repeated based on improper data collection and analysis processes. Bioequivalence studies, often conducted to bring generic drugs to market, establish that the generic drug has the same ‘effect’ as the original drug. Obviously, these are critical trials, as they also establish the safety...

Oh, That Looks Cool! – Riding the mHealth Wave

Innovation comes in many shapes and sizes from a unique user experience to game changing, disruptive, enterprise process changes. Innovation is something that's...

Innovation comes in many shapes and sizes from a unique user experience to game changing, disruptive, enterprise process changes. Innovation is something that's great to experience and deliver. It’s often detected by an initial emotional response typically triggered by some visual stimulus (or claim), which is somehow instantaneously converted to a real or perceived benefit. Conversely, innovation can become quickly blurred by hype, distracting us from the actual, realizable...

Real World Data - A Key Factor for Pharmas and Payers by James Streeter

Today, real world data is becoming a key type of support, not only for pharmaceutical companies, but also for payer institutions. This kind of real world...

Today, real world data is becoming a key type of support, not only for pharmaceutical companies, but also for payer institutions. This kind of real world evidence enables both pharmas and payers to understand how drug products are actually working for patients in the real world. For years, pharma companies have been buying data from many different sources to endorse the value of their drugs in the market. Recently instead, payers have been demanding that drug companies...

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 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...

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...