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[…]

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[…]

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[…]

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[…]

Pharma: Not Everyone is a Project Manager But Everyone Manages Projects

The other day, a client asked me to define “project management.” I defined it broadly as the organization and management of work in an effective and useful manner. Based on that definition, I asserted that everyone in the pharmaceutical industry is a project manager. And I suggested that the more important question is not what project management[…]

Shining Light on the Sunshine Act

After the Physician Payment Sunshine Act (PPSA) passed in March 2010, most companies took a “wait-and-see” approach. They planned to wait until they absolutely, positively had to deal with its requirements. And with companies juggling so many priorities, it’s understandable that it would slip to the bottom of the list. The PPSA has now forced[…]

Clinical Operations Process Improvement (Part II The Ultimate Metric)

There has been a big push recently to execute on more and more improvement projects.  This is thanks in part to the application of lean sigma for clinical operations. But, the financial benefits of an improvement project are not easy to figure out. For example, many such projects, and the metrics surrounding them, revolve around cycle-time[…]

Improving Clinical Operations Metrics (Part 1 – Metrics That Matter)

In the pharmaceutical industry, costs are becoming an increasingly scrutinized component of the clinical development process.  Companies are looking to increase profits by getting drugs to market faster. They are trying to bolster margins by conducting trials with the fewer and fewer resources.  Along these lines, many clinical operations groups are collecting clinical trial metrics as fast as they[…]

Improving the Sponsor-CRO Relationship through Collaboration Portals

On any given day we see the announcement of a new strategic partnership or global alliance. Outsourcing to CROs is no longer big news. However, there is plenty of buzz over how these partnerships are performing.  With the mounting pressure for innovation and efficiency, sponsors need CROs more than ever in order to survive. Yet[…]