Transformation: Processes

According to the eClinical Solutions’ Industry Outlook 2023, harnessing automation throughout the clinical data life cycle was the top industry focus for more than one-third (36%) of respondents. Across the data life cycle, from acquisition to insight, there are multiple applications where automation can streamline routine tasks. For example, at eClinical Solutions, our teams are applying automation to create efficiencies within database build, and automation and machine learning approaches to complement manual data cleaning. Organizations can also leverage automation to support data integration and statistical analysis tasks, leading to higher data quality and efficiency. As biometrics leaders incorporate automation into their processes, they should focus on developing their team’s skills, while prioritizing the selection and implementation of tools that align with the organization’s goals and integrate well into existing workflows.

Against the backdrop of trial complexity, incorporating risk-based approaches enables biometrics teams to focus their resources on the most critical data, ensure overall quality, patient safety and comply with ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and regulatory guidance. As well as meeting these requirements from regulatory agencies to use effective risk management practices, there is growing recognition of the value of risk-based approaches in improving efficiency and cost-effectiveness of clinical trial operations while reducing the burden on teams. Incorporating RBQM (risk-based quality management) typically involves adopting new technology platforms, as well as developing standard operating procedures (SOPs) and upskilling staff on RBQM practices. Leaders can practice a stepwise approach to adoption by leveraging an RBQM solution that is integrated with a clinical data platform, or ‘starting small’ with pilot studies, a single process, or adopting ‘out of the box’ solutions such as standard KRIs across their studies while refining an overall RBQM strategy.3 https://www.eclinicalsol.com/webinars/overcoming-barriers-to-rbqm-adoption/

In the context of extensive data collection outside EDC, processes and technologies to manage external data are essential tools of biometrics delivery. In recognition of this importance, at eClinical Solutions, our Biometrics Services team has established a Center of Excellence for External Data to drive best practices and create efficiencies through standardization, while leveraging elluminate. As biometrics functions evolve, alongside implementing technologies to handle large volumes of data from multiple sources, they can focus on best practices, relationship management and standardization initiatives. For example, engaging closely with external data vendors to assess their data quality and reliability, establishing strong communication and relationships, and implementing standardized Data Transfer Agreements (DTAs) are all practical steps. For effective external data management, organizations may also set up systems for tracking KPIs (Key Performance Indicators) such as data quality, accuracy, and timeliness and use technologies to enable visibility.

Decentralized trials (DCT) offer significant benefits for trial recruitment, retention, and operations, however, there are challenges for sponsors with adoption, developing capabilities, and handling data complexities. As uptake of decentralized trials increases, biometrics teams will need to consider and address any gaps in their technology stack and capabilities such as specialized DCT platforms, DCT- enabled analytics, and biometrics outsourcing services with DCT-trained professionals. With change management top of mind, leaders should ensure that team members have the necessary skills and training to effectively utilize these technologies and navigate the rapidly growing vendor ecosystem.