SOURCE: Cutting Edge Information

Cutting Edge Information

July 09, 2015 10:30 ET

Clinical Study Sponsors Outsource an Average of 68% of Data Management Responsibilities per Trial, According to Cutting Edge Information

Clinical Trial Best Practice: Leverage External Partnerships to Supplement In-House Capabilities and Broaden Existing Expertise

RESEARCH TRIANGLE PARK, NC--(Marketwired - July 09, 2015) - Research by primary intelligence firm Cutting Edge Information suggests that clinical teams undertake different outsourcing approaches, particularly in terms of trial operations. For some life science teams, specific outsourced tasks are part of a larger master services agreement with contract research organization (CRO) groups. In other situations, teams leverage CROs as functional service providers (FSPs). Regardless of the type of partnership, CRO contributions should supplement in-house capabilities and broaden existing expertise.

Many teams outsource trial execution tasks like data management, statistics and clinical monitoring. To address sponsor needs, many CROs have developed in-house teams, such as clinical operations (84%) and data management (74%). According to Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines, a recent report by Cutting Edge Information, an estimated 94% of surveyed pharmaceutical and device teams assign some level of data management responsibilities to third party solution providers. Moreover, the teams that elect to outsource data management in any capacity outsource an average of 68% of these responsibilities.

Data management responsibilities range in scope from conducting frequent data reviews to preparing finalized reports. Often, the sheer volume of data management tasks prompts teams to consider at least partially outsourcing their responsibilities. For example, teams may not have the bandwidth in-house to perform data reviews with the frequency that clinical studies require. Alternatively, once studies are underway, companies may determine that more data than originally anticipated is necessary.

Because teams outsource a high percentage of data management, unforeseen changes to data management strategy can create trial setbacks. Executives interviewed for this research emphasized the stark difference between asking their own teams and CRO groups to take on additional work. What may represent an additional time investment for in-house teams may necessitate a change order and create an added trial expense, when working with CROs. However, "early planning helps teams balance the workloads of internal and external teams -- and prevent surprises," said senior research analyst Sarah Ray.

"Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines", available at http://www.cuttingedgeinfo.com/research/clinical-development/outsourcing-selection-strategy/, provides best practices for vendor management. The report also examines patient recruitment, site selection criteria and outsourcing metrics. Report highlights include:

  • Metrics detailing clinical trial activities from pharmaceutical, device, CRO and site perspectives
  • Data on surveyed teams' vendor selection process and preferred collaboration type (master services agreement versus functional service provider)
  • Best practice recommendations and projected costs associated with selected patient recruitment activities
  • Profiles of 17 pharmaceutical, biotech, device and CRO-managed clinical trials, including overall trial costs, number of enrolled patients and sites and clinical team size

For more information about "Clinical Outsourcing: Leverage Sponsor-CRO Relationships to Accelerate Trial Timelines" and vendor selection criteria, please visit http://www.cuttingedgeinfo.com/research/clinical-development/outsourcing-selection-strategy/.

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