Will Remote Clinical Trials Become the New Norm?

By some counts, prescription drug costs account for 20% of all healthcare costs.  The cost of getting a drug to market reaching well over a billion dollars and there is a growing scrutiny of money-conscious consumers. It is not hard to see why pharma companies are searching to find ways to reduce costs. Clinical trials[…]

Clinical Operations Process Improvement Metrics (Part V – Take the Long View)

In previous blog posts, I’ve zeroed in on two of the three main areas where companies struggle with metrics. This time, I’ll focus on the third – the use of short-sighted metrics. “Localized metrics” are metrics that measure small (individual or departmental) goals. They do not have a link to broader company objectives. This use can[…]

Who am I? An Identity Management Crisis

Is it Greg Cohee, greg.cohee, gcohee, Greg_Cohee1, or GJC!2X785cze????? Ok, maybe you remember who you are but what is your password…today…for which system? Computers are pervasive in today’s workplace and our personal lives. They are a part of every process and do a great job of storing large amounts of data. They can ‘remember’ data[…]

Understanding Kaizen: It’s Mathematical

Math is the Queen of Science, beautiful and precise.  With math there is no wiggle room, it is not open to interpretation.  Math is black and white, 1’s and 0’s, and not something you can spin.  It is what it is.  So how is kaizen like math? Both are Principle Based We’ve all seen examples[…]

Clinical Operations Process Improvement (Part III – TMI!)

The biggest mistake companies make when working with metrics is that they tend to make things way more complicated than they need to be. Specific examples abound. You can boil down these examples into three general categories. I will discuss the first one here. Collecting Too Much Data Collecting too much data makes it hard to focus[…]

Carlin, SharePoint and Mid-Size Pharmas: For the Love of ‘Stuff’

Remember the George Carlin bit about “stuff”? If you’ve never seen it—or if you just need a five-minute break—go to YouTube and check it out. It was 30 years ago when Carlin shared his astute and ever-humorous observations about our addiction to “stuff”. This included his belief that a house is nothing more than “a pile of[…]

Resource Management: To Algorithm or Not to Algorithm?

Demand forecasting—the ability to project demand by role and project—is an important part of resource management. Companies conduct demand forecasting in several ways. Some have project managers enter demand by role for, say, 12 months. Others communicate standards to help drive consistency in how project managers estimate demand. Still, others create demand forecasting algorithms to[…]

Stop the Spreadsheet Madness

In the summer, nothing beats going to the shore. But if you’ve ever brought food on the beach, you know about seagulls. They’re relentless and annoying, and they have a way of overwhelming you. Actual birds probably won’t invade your office. Chances are, you still experience some “seagulls” at work: Excel spreadsheets and Word documents.[…]

CRO Data Integration: Your CTMS or Mine?

The pharmaceutical industry in 2013 will continue the downsizing of drug development operations.  In doing this, they will place an ever-greater reliance on strategic CRO alliances and collaborative technologies. As sponsors increase their reliance on CROs, the need for better collaboration and more transparency will also increase. Data Collection In managing a study, CROs must use[…]