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How Clinical Research Organizations Are Transforming in Today’s Environment—Part 1

Published By Wolfram Eberstein
How Clinical Research Organizations Are Transforming in Today’s Environment—Part 1

There is a significant transformation underway in the clinical research organization (CRO) space. The CRO market revenue amounts to approximately $30 billion, which is primarily generated from its core business of conducting clinical trials required for drug market admission by regulatory authorities like the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Further revenue is generated by consulting services around market introduction and support in medical communications. This two-part blog series will discuss the challenges CROs are facing and what they can do to manage the growth.

Over the last 15 years, CROs have seen a 10-15% growth rate primarily because of increased outsourcing of clinical research from the big pharmaceutical companies and the emergence of numerous biotech companies creating new business. According to industry analysts, this trend is expected to continue.

Although growth may be inevitable, CROs remain challenged to adapt to this volatile environment. The emerging initiative for CROs is to form strategic partnerships with big pharmaceutical companies to obtain clinical research outsourcing resources like staff and facilities while merging processes as much as possible. Some examples of these partnerships are Eli Lilly with PAREXEL®, Sanofi with Covance, Astellas with INC Research®, and Pfizer with Icon and PAREXEL.

Adding to the challenges of rapid growth is the need for a global footprint to service international customers and market consolidation due to mergers and acquisitions. As a result, many CROs:

  • Are pressed to establish global, cost-efficient processes that provide corporate data of the operational business in a consistent way
  • Struggle with a desire to deliver studies quickly and with reliable results within the strict regulatory framework, yet are severely obstructed by fragmented, regional or partly existing processes
  • Have systems that aren’t fully integrated, leading to duplicate data entry and inconsistencies

In the new CRO world, clinical data, general project data, financial management data, and planning data will be integrated more effectively and made readily available. The next blog will discuss how CROs can spearhead their existing global data challenges to effectively align resources to the right projects while improving financial visibility to drive better business decisions.

For more information on this topic, read Louise Allen’s blog titled SRP — Changing the Game for Services Driven Organizations. I’d like to hear from you. How are the changes in the clinical research industry affecting your organization? Share by leaving a comment below.

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Written by Wolfram Eberstein

Wolfram Eberstein is managing consultant for the central European region at Planview. He brings more than 18 years of experience in project and portfolio management to the telecommunication and clinical research industries. Prior to Planview, Wolfram was the vice president of corporate project management office at PAREXEL® where he developed project management processes and governance and was program manager for rolling out an integrated ERP and project portfolio management (PPM) system to a globally diverse organization in six business units. Prior to PAREXEL, he held the general manager position for project management and development at Mobisphere and oversaw a joint development initiative of third generation mobile telecommunication equipment.