Three Ways to Drive Vaccine Trials Through Integrated Clinical Development and Laboratory Services
On average, pharmaceutical companies outsource 40-45% of their clinical activities to contract research organizations (CROs). Experts anticipate that number will continue to grow in the future, especially since those that leverage integrated clinical development and laboratory services offered by a single CRO gain significant advantages.
Additionally, vaccine trials and laboratory needs show little signs of slowing down. Given the increasing complexity and speed with which vaccine trials must move, a disparate approach to outsourcing can lead to challenges with study data, communication and overall quality. Vaccine developers must think strategically about how to outsource their projects and integrate clinical development and lab services.
For vaccine trials, a large amount of subject data must be collected in a short period. This can result in hundreds of thousands of laboratory specimens and millions of case report forms within a single study, paired with a need to meet aggressive project delivery timelines.
When it comes to vaccine development, here are three advantages of working with CROs that have integrated clinical development and laboratory services.
1. Leveraging integrated data to improve vaccine study data quality
Access to consolidated, transparent data is the first benefit to integrating clinical development and laboratory services. For example, Thermo Fisher Scientific’s PPD clinical research business utilizes its award-winning Preclarus® technology platform to merge laboratory and clinical monitoring data on a nightly basis. Merging the data each night quickly surfaces discrepancies between the clinical and lab databases and facilitates reconciliation activities.
The combined database improves data currency. It also enables near real-time access to the tremendous amounts of subject data needed to:
- Support safety trends analysis
- Provide feedback on immunogenicity measures
- Guide ongoing decision-making during the trial
In a four-study program with a long-term client, PPD recognized the sponsor was working in a legacy partnership management model based in transactional structure with redundancies and a lack of standardized systems. To overcome this, PPD leveraged its Preclarus solutions, thereby increasing the availability and transparency of patient, laboratory and operational data. As a result, the client was better able to manage a fluctuating pipeline and could easily access and drill into the data, making it easier to spot study trends early on. It also reduced costs associated with data reconciliation activities.
2. Utilizing integrated services to improve project communication
The synergy of services of an integrated laboratory and clinical solution offer direct access to key study data sets and metrics. It also enables sponsors to communicate with one dedicated team instead of several subgroups from the use of multiple CROs. A strong connection with one team drives improved resource allocation, quality processes and laboratory scheduling.
Additionally, since the laboratory team overlaps with the broader clinical development team, labs are involved in the trial planning process earlier, providing customers with the ability to optimize protocols and overcome study hurdles more quickly.
3. Improving overall study quality and patient safety through integrated services
Our experts find that pharmaceutical companies often see marked improvements in overall study quality when services fall under a single CRO. A single vaccine study can produce thousands, if not millions, of study samples for sponsors to test or store for future use. An integrated data solution enables complete 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 dashboards and portals aid in the early identification of site-level exceptions or adverse events. This enables researchers to spot overall study risk factors, drive timely intervention and support proactive review of safety concerns.
For example, in a recent Phase I asthma trial PPD clinical research services’ integrated lab and clinical solutions made it easy for study staff to visualize safety monitoring across eight different cohorts. As a result, investigators were better able to protect participants and make rapid, informed decisions for dose escalation.
Pharmaceutical companies can take their vaccine development projects to the next level with a CRO partner that offers integrated clinical development and lab services.
Enhanced data monitoring, project communication and patient safety are just three of the benefits of an integrated clinical development and laboratory services approach.
Preclarus is at the heart of PPD’s clinical trial services, providing reliable, integrated data in real time to inform decisions. It includes a proprietary, web-based enterprise and information management system, a single global database for central lab activities, and interactive dashboards and data portals for study sponsors, investigators and project teams. For vaccine developers, this optimizes the time and resources of your study and enables you to make more informed decisions faster.