A Clinical Project Manager Takes a Walk in the Woods…with the Clinical Development Team

All drug development programs are not created equal, and rarely are they the same within a single therapeutic area. A project manager on a drug development team needs to optimize the team network available. He also needs to use gained experience since a program can take many paths. As I make my initial assessment of[…]

Decision Making in Big Pharma vs. Small Pharma

On many occasions, I have the opportunity to speak with leaders at small pharmaceutical and biotech companies. They always say, “We don’t operate like big pharma” or “I’m not interested in hearing the best practices from big pharma.” As a younger and less experienced leader from big pharma, I couldn’t fathom what they meant by[…]

Clinical Operations Process Improvement Metrics (Part IV – Getting It Right)

As I’ve mentioned in previous blogs, many companies struggle with getting their metrics right. Examples of these struggles abound but usually fall into three general groups.  Last time I talked about collecting too much data.  Now I will discuss the second one, poor/misaligned data or lagging metrics. Each company is different and must decide for itself which[…]

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[…]

Compliance. It’s Never a Problem Until it’s a Problem

  These are the words I often share with clients when talking about compliance problems.  What I mean by, “It’s never a problem, until it’s a problem,” is that: It is difficult to foresee everything when it comes to compliance Most problems will not rear their ugly head until late in the game Don’t try[…]

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[…]

Can Risk-Based Contracts Enhance the Sponsor-CRO Relationship?

The sponsor-CRO relationship continues to shift toward alliances and partnerships. It is no surprise that there is an emergence of risk-based or performance-based contracts in clinical trials.  One would think this would be a winning proposition for both parties. However, the comments I hear from our clients on both sides seem counter-productive to the relationships they[…]

Clinical Systems Vendor Selection – Six Things You Need to Do!

  The systems used in clinical R&D (or commercial, or HR, or finance…), like everything else in the world, eventually grow old and stop working the way we’d like them to. Fortunately, these systems can be replaced – though not necessarily any more cheaply or easily than your Uncle Irwin’s hip. Done the right way,[…]

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[…]