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clinical operations Archives - Pharmica Consulting
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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 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[…]

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 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[…]

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[…]

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[…]