Successful project delivery through laboratory and clinical integration
Jason Berg, senior director of PPD vaccines and Lindsay Brady, manager of the project management group within PPD Laboratories’ vaccine sciences lab, discuss how integrated operational and laboratory functions can increase project delivery success.
In many cases, clinical studies are being outsourced by pharmaceutical companies, which can ultimately involve several different clinical research organizations (CROs) in the process. Specifically, in vaccine trials, this outsourcing is common since a large amount of subject data needs to be collected in a very short window of time. The result can be hundreds of thousands of specimens and millions of case report forms (CRFs) within a single study, paired with a need to meet aggressive project delivery timelines.
While common, this outsourced approach can lead to challenges with study data, communication and overall quality. In comparison, integrating clinical development and laboratory services offered by a single CRO offers significant advantages in these three areas.
How can integrated services improve vaccine study data?
Access to consolidated, transparent data is the first benefit to integrating clinical development and laboratory services. For example, PPD utilizes Preclarus®, our innovative technology platform, to merge laboratory data and clinical monitoring data on a nightly basis. Merging the data nightly surfaces discrepancies between the clinical and lab demographic data quickly and facilitates reconciliation activities. The combined database improves data currency and enables near real-time access to the tremendous amounts of subject data needed for vaccine trials to support safety trends analysis, provide feedback on immunogenicity measures and guide decision-making during trial conduct.
How can integrated services improve project communication?
The synergy of services secondly offers improvements in communication. Not only can Preclarus offer direct access to key study data sets and metrics, but sponsors can also communicate with one dedicated team instead of several subgroups that result from the use of multiple CROs. A strong connection with one team can result in improved resource allocation, laboratory scheduling and streamlined quality processes. Additionally, since the laboratory team overlaps into the broader clinical development team, labs are involved in the trial planning process earlier, providing customers the ability to optimize protocols and overcome study hurdles more quickly.
How can integrated services improve overall study quality and patient safety?
Thirdly, there have also been marked improvements in overall study quality when services fall under one CRO. A single vaccine study can produce thousands, if not millions, of study samples to either be tested or stored for future use. Utilizing data solutions such as PPD’s Preclarus allows for full visibility to these samples, with details on when they have arrived at the intended locations and where they are in the testing process.
With patient safety as the utmost concern in any trial, integrated service tools such as the dashboards and portals that are a part of Preclarus, can aid in the early identification of site-level and overall study risk factors, driving timely intervention, action and review of safety concerns.
More than a decade of experience with integrated services
PPD is proud to offer more than ten years of experience integrating clinical development and laboratory data to speed decision-making and bring vaccines and therapeutics to market faster. We’ve integrated clinical development and laboratory data for hundreds of trials.
If you would like to hear more detail about the benefits of the integrated clinical development and laboratory approach, watch as two of our experts present the benefits of integrated services including a recent case study.