This multinational pharmaceutical organization is committed to developing innovative drugs to meet the unmet needs of patients and make the impossible possible. The company has introduced over 70 innovative products to China over the past 30+ years, including original drugs and vaccines.
Critical to its success, the pharmaceutical organization’s Asia Pacific research
and development center (the Center) based in China, provides comprehensive support services — including clinical trial management — for development projects across the company’s global product line.
Scaling clinical trials for success
Clinical trial activation and management is one of the research and development hub’s most manual and time-consuming processes.
The Asia Pacific Center runs around 100 worldwide clinical trials concurrently, ranging from small Phase 1- to huge Phase 3-studies. The Center’s clinical research associates (CRAs) are crucial in conducting clinical trials by ensuring integrity, quality, and compliance with study protocols, standard operating procedures (SOPs), and regulatory requirements.
Specific activities performed by CRAs include clinical site monitoring, site initiation, routine monitoring, maintenance of study files, study close out, and retrieval of study materials, as well as on-site and remote monitoring activities including source document verification.
The goal of the Center was to obtain a scalable solution to track the performance of each CRA, especially on large, global Phase 3 studies where complexity of regulatory requirements vary, as do logistical challenges associated with ethics review, drug supply and biospecimen management.
The challenge faced across all these processes is the volume of data and the different methodologies used worldwide. With around 20,000 CRAs globally, the Center sought to develop a way to standardize and measure CRA effectiveness quickly via some key performance metrics.
Key performance indicators (KPIs) provide evidence-based, directional insight on progress, enabling operational processes to be optimized, resources to be prioritized, and accountability to be assigned, to ultimately achieve the organization’s objectives and goals.
Intelligent KPIs, powered by artificial intelligence (AI) and equipped with embedded governance, make the insights and metrics more intelligent, predictive and adaptive.
Revolutionized clinical trial management
Having worked on systems used within the clinical trial process for many years, the Center chose to partner with DXC Technology based on its experience and understanding of the process and its leading-edge technology expertise.
Over the past decade, DXC has mastered the AI lifecycle across three specific areas — design, engineering, and scaling — and perfected its expertise in the clinical trial process using AI-enabled intelligent solutions to monitor CRA effectiveness, helping to identify, on an individual basis, potential compliance issues and helping CRAs determine the next best actions.
To accelerate the Center’s AI adoption journey, DXC’s Analytics team conducted human-centered design thinking workshops to understand the problem and identify potential solutions. Its mission to transform the process stemmed from DXC’s understanding of how untenable it was for the Center to continue tracking data from tens of thousands of CRAs on multiple spreadsheets.
While the effectiveness of a CRA can be determined by factors such as education, experience, personality and motivation, specific metrics can be used to evaluate performance and skills more formally. Metrics incorporated for measurement in the solution included:
- Quality of the investigator initiation package (IIP)
- Initial and verbal informed consent completed
- Monitoring visit frequency
- IIP due diligence compliance
- Serious adverse event reporting
- Patient re-consent
- Issue identification and resolution time
- Sites delinquent in data entry
To accelerate the Center’s AI adoption journey, DXC’s Analytics team conducted human-centered design thinking workshops to understand the problem and identify potential solutions. Its mission to transform the process stemmed from DXC’s understanding of how untenable it was for the Center to continue tracking data from tens of thousands of CRAs on multiple spreadsheets.
DXC’s scalable solution allows data consolidation from multiple disparate sources, including primary data capture solutions, clinical trial management platforms and site management systems to measure CRA effectiveness globally.
An evaluation accelerator was built to drive adoption, enabling the Center to run AI on its own data. This ensures it’s safe because it’s geared towards acting on internal data, with the evaluation logic helping to evaluate systematically, taking an empirical approach and eliminating guesswork.
Business intelligence and operations performance reports were provided related to: investigator initiation package quality, monitoring visit frequency, due diligence compliance and serious adverse event reporting.
Harnessing analytics to optimize outcomes
DXC’s analytics solution, featuring intelligent KPIs powered by AI, has helped the Center solve its operational and technological challenges by capturing and synthesizing edge-to- core data from multiple sources, and converting it into analytical insights to enable data-driven decision-making.
Around 40 of the Center’s offices now use the solution to better understand the performance of its 20,000 CRAs worldwide. It supports the Center in transforming and optimizing its clinical trial process by streamlining and accelerating startup time, and automating the effectiveness of CRAs. It also facilitates faster innovation by quickly uncovering insights, patterns, predictions and recommendations at scale. Better data visibility ensures processes are transparent, auditable, and compliant with regulatory requirements.
With a better understanding of the highest-performing CRAs and specific behaviors and business practices that generate success, the Center can incorporate these learnings into formal workflows to improve processes. The engine can also educate CRAs to work smarter, with actionable insights used in training and development to identify and address knowledge or protocol compliance gaps for improved performance.
