Clinipace Worldwide Delivers Transparency in the Successful Performance of a Phase III Dialysis “Rescue” Trial

The “David” of CROs among a sea of “Goliaths” restored trust to the trial offering agility, efficiency, and consistency that traditional models often lack

A west coast biopharmaceutical company was in the process of a Phase III dialysis trial involving over 100 North American centers and approximately 1500 patients. Originally contracting a larger CRO for the study, this complex trial required concentrated monitoring and tight project management. As the trial progressed, the company realized the large CRO lacked transparent trial management and the resources required to complete the trial in time to meet New Drug Application (NDA) goals and investment-related deadlines.

Looking for a partner that would provide more trial performance visibility, the company employed Clinipace Worldwide in October 2009 to “rescue” and augment the monitoring of the trial, effectively manage and achieve milestones, meet project timelines, and optimize resources and communication pathways.

Process in Motion

With a resource model based on the needs of each customer, the biopharmaceutical company chose Clinipace Worldwide to save money and time.  A more efficient and affordable study with “lean” clinical research processes would minimize data integration, reduce project startup costs, and empower project stakeholders to make informed data driven decisions.

Needing to get a handle on the backlog built up from the previous CRO, Clinipace Worldwide leveraged its CRA network to deploy 37 monitors in less  than two weeks. Clinipace Worldwide conducted a two-day training session for  all CRAs in collaboration with the sponsor, and was able to deploy monitoring  teams virtually immediately, typically unheard of, and get the process up and  moving again very quickly.

Clinipace Worldwide, unlike other CROs, enables its Clinical Research Associates (”monitors”) to serve as the site manager.  This ensured strong monitor site relationships and expedited replies to monitoring requests.

The synergy of this relationship was beneficial to all parties and made execution of requests  smooth and timely.  The trial team escalated findings of inadequately monitored  tasks across the team in weekly Clinipace Worldwide conference calls. This ensured the entire monitoring team was on the same page to apply solutions  and increase data quality.  These findings were also crucial from a communication perspective as the project management team was able to relay this information to the client and allow for “real time” assessment and decision making to address the findings in a number of ways (i.e., client Good Clinical Practice (GCP) audits, client interaction, etc.) and improve overall data quality.

In addition, Clinipace Worldwide remediated accrued documentation and files from the sites previously managed by the other CRO, and implemented integrated monitoring and study management practices to ensure data quality.  Clinipace provided 100 percent transparency in all operational transactions with the trial and remained consistent throughout the entire relationship. Any bumps along the way were reported, assessed, and fixed. There was never a doubt as to what work was being done, how, and the results.

The clinical operations services enabled the biopharmaceutical company’s stakeholders to view the study’s progress anyplace and anytime, and make informed real time decisions regarding their research leveraging,

  1. Data validation and cleansing
  2. Quality assurance
  3. Data reconciliation

The company also needed to ensure regulatory compliance within the various documents and data coming from and going to each site. Clinipace Worldwide managed site logistics, documentation, reporting, site file notebooks, regulatory file review, site status reporting, and site close out tasks.

Measuring Success

From an investment standpoint, the biopharmaceutical company measured success on a timeline. If the company didn’t complete the trial with data cleaned and locked, the investors would not be in a position to make the commitment needed to advance the drug.  Throughout the time that Clinipace Worldwide was involved with the study, a Governance Committee made up of executives from all service providers involved in the trial met to discuss strategy and solutions.

With a commitment to open and transparent communication, a checks and balances of processes in place provided,

  • GCP adherence
  • Project visibility and lifecycle management
  • Comprehensive project and communication plan
  • Collaboration with sponsor to create monitoring, and site management plans

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