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Reflecting on Clinical Research Industry Headlines of 2012

Addressing CRO Challenges with Services Resource Planning

December is often a time to reflect on achievements, ponder on lessons learned, and set goals for the New Year. It is as if Charles Dickens’ A Christmas Carol has saturated the subconscious and I expect the Ghost of Christmas Future to appear this evening and tell me what I missed when all of the telltale signs were there.

For resource managers within clinical research organizations (CRO), all signs are particularly focused on the transformations underway in the market. To echo Wolfram Eberstein’s latest blog series, CROs are facing unprecedented levels of challenges in regards to regulations, corporate mergers, growth, and increased outsourcing.

How these changes will affect cost and performance should be of concern. Here’s a quick review of some of the headlines of 2012 that emphasize the degree of urgency.

  • The results from sweeping regulatory reform are in. In Europe, the impact of the EU Clinical Trials has been such that CROs are seeing their manpower costs essentially double (Telegraph Media Group, 2012).
  • Marketing dynamics are changing. According to a Booz & Co. survey targeting pharmaceutical sales and marketing executives about their commercialization strategies; 60% of respondents are expecting their service models to change, and as a result, estimate corporate strategies to rely heavily on “innovative pricing” (FiercePharma, 2012).
  • The pressure for transparency and reliability is paramount. Phase II costs range between $4,000 to $20,000 per patient. According to Timothy Scott of Pharmatek Laboratories, “…the reliable supply of clinical trial material (CTM), whether manufactured in-house or outsourced to a contract manufacturing organization (CMO), absolutely critical” (FierceBiotech Clinical Trials, 2012).

What might the creepy ghost forecast tonight knowing what we know today about new costs, technologies, and solutions? What might I be able to do about it as soon as I wake?

We know that services resource planning (SRP) technologies are now available and have been designed to assuage many of these concerns directly. Not by implicitly reducing costs or making magically accurate predictions. Rather, SRP takes off where enterprise resource planning (ERP) and professional services automation (PSA) fail at recognizing the resource challenges of project-based organizations that need to link business operations from end-to-end.

During their evaluation of available enterprise-focused software offerings, analyst firm IDC has defined SRP solutions as an important tool for CROs:

“SRP systems pull three major business components ‒‒ resources, projects and clients ‒‒ together into one system supported by strong analytical and collaborative capabilities. Integration is the key to removing to driving more effective business strategy, and beyond strategy, an integrated system provides a solid operational foundation often preventing problems from getting out of control and enabling proactive business decision-making” (IDC, 2012).

Will implementing a system designed to manage and predict capacity and resources for CROs keep the Ghost of Christmas Future from appearing in your dreams this week? Perhaps not… I do know, regardless, you will be sleeping better with an SRP solution than without one in 2013.

To learn more about SRP for CROs download the Planview Approach to Services Resources Planning for Clinical Research Organizations. Dive into the five functional areas an SRP solution must have to help CROs produce effective resource planning practices.

What market changes/challenges are you reflecting on within your CRO? What steps are you taking to improve resource planning in 2013? Share your thoughts by leaving a comment below.

EU red tape making drugs impossible, The Telegraph Media Group, February 13, 2012 (as cited by Planview Approach to Services Resources Planning for Clinical Research Organizations)
Pharma sales execs: Current model is broken; changes are coming, FiercePharma, March 21, 2012
eBook: Supplying Global Clinical Trials Keys to Avoiding Costly Delays, FierceBiotech Clinical Trials, April 2012
IDC Executive Brief: Services Resource Planning: Systems for Effectively Managing a Project-based Business, June 2012

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Kerry Raminiak
Written By

Kerry Doyle Raminiak writes and manages the development of thought leadership materials within the purview of project-based business operations and corporate financial long-range planning. Before joining Planview, Kerry owned and operated a marketing communications firm that specialized in developing messaging for software, web-based applications, and other technology niches. Kerry has a BS in Communications from Towson University Maryland, and an MA from Pepperdine University.