Expanding access to data — coupled with powerful analytics and advanced technology platforms — drives research innovations that improve data quality, reduce time and cost and increase the likelihood of conducting a successful clinical trial. The Preclarus® centralized data repositories and common workspace support collaborative trial designs and operations. Preclarus’ real-time data access underpins two major clinical trial innovations — adaptive and intelligent approach to risk-based monitoring and adaptive trial design. The Preclarus central lab data base and Preclarus investigator site portal ensure real-time access to comprehensive laboratory data for the entire project team. Preclarus also provides a platform to advance connectivity through mobile devices to create new models for clinical evaluation and laboratory services.
Adaptive and Intelligent Monitoring
Preclarus real-time data solutions and dynamic analytics facilitate PPD’s adaptive and intelligent monitoring—a major shift to technology-driven monitoring practices that improves operational efficiency and data quality.
PPD’s clinical teams identify and detect anomalies in data using Preclarus’ dynamic analytic dashboards to view site health assessments and analyze key risk indicators (KRI) at each study site. Teams then perform a root cause analysis of these variances to prompt remote and on-site monitoring visits, during which changes can be implemented to mitigate risks before problems arise. This adaptive approach to risk-based monitoring has changed the way clinical teams perform their jobs. For instance, CRAs no longer spend their time on-site pursuing and resolving a list of problems. Instead, they focus on working with study sites to assess processes, anticipate problems and enact improvements to address potential safety issues and avoid potential errors and delays.
Harnessing the expertise of our clinical personnel and the capabilities of our comprehensive data portfolio solution helps PPD reduce the frequency of on-site visits and the level of source data verification (SDV), while maintaining close, quality oversight of clinical trial sites. Preclarus enables PPD to take advantage of industry-leading people, technology and processes to provide effective and efficient adaptive monitoring solutions for clients.
Adaptive Trial Design
Adaptive trial design provides a major opportunity for drug developers to improve success rates
across the drug development continuum. With the power of Preclarus, PPD is able to provide the robust real-time data acquisition, aggregation, cleaning and analysis capabilities that are the necessary foundations for successful execution of adaptive trial designs.
With more insightful interim analysis and real-time data delivery, Preclarus benefits studies employing adaptive trials designs through:
- Faster go/no-go decisions that save clients time and money
- Better early development decisions on dose and frequency
- Critical information to stop trials earlier for ineffective or unsafe drugs to increase safety and improve patient experience
Mobile devices — from tablets and smartphones to wireless, wearable health monitoring devices—promise to reshape the health care landscape. Mobile health is rapidly evolving to address the full spectrum of health evaluation and care delivery through such approaches as monitoring and reporting patient metrics, guiding and tracking lifestyle interventions, and prompting patient compliance and adherence with medication reminders and reinforcements.
PPD’s goal is to foster new and disruptive ideas across the clinical development process. We are committed to ongoing investment and advancement of Preclarus—an industry-leading platform to revolutionize clinical drug development.
Harmonized Lab Data
The central lab database and portal showcase and integrate data in unprecedented ways. Data standardization and reconciliation happen automatically within the dashboards, eliminating the need to merge and harmonize data from different systems, enabling the fastest study start up in the industry and saving hundreds of hours at the end of a trial.