What Sites Need: Trial Technology Integration, Support, And Evaluation
By Jimmy Bechtel, Society for Clinical Research Sites
Integrating a new site technology with existing systems, such as clinical trial management systems (CTMS) and laboratory information management, is a core need for sites to operate efficiently. According to the 2024 SCRS Technology Landscape survey, 28% of sites are concerned about the cost of technology and 28% are concerned about the lack of integration. (The survey is available on the SCRS website or as a recording from the SCRS Global Site Solutions Summit.)
Seamless integration ensures that data flows efficiently across platforms, reducing the risk of errors, duplication, and inconsistencies. Two best practices for tech integration are:
APIs and Data Standards: Use application programming interfaces (APIs) and adhere to industry data standards like CDISC to facilitate smooth data exchange between systems. Single sign-on is a valuable time-saver in our industry, so assuring this is a capability between systems is a valuable ask.
Vendor Collaboration: Work closely with technology vendors to ensure compatibility and integration capabilities. Vendors should be able to provide integration support and ensure that their solution can coexist with other critical systems. This goes for both existing vendors and any new ones being considered.
Customizing Technology To Meet Specific Trial Requirements
Every clinical trial and technology solution is unique and must be adaptable to meet specific requirements. Customization may involve configuring data collection forms, workflows, and reporting tools to match the needs of different study protocols.
Modular Systems: Consider modular solutions that allow sites to select and customize only the features they need. This flexibility can help in tailoring the technology to specific trials without overcomplicating the system. Not every trial and instance will need all of the features and functions of a particular technology or tool.
User Feedback: Engage end users such as site staff and patients in the customization process to ensure the technology meets practical needs and is user-friendly.
Site Infrastructure To Support Technology Implementation And Integration
Thirty-four percent of sites indicated that staff preparation is the top need to prepare for technology in trials, according to SCRS survey results. Before adopting new technology, sites must evaluate their existing infrastructure, including hardware, software, and network capabilities. The infrastructure must support the technology's requirements, such as processing power, storage capacity, and internet bandwidth.
IT Assessment: Conduct a thorough IT assessment to identify potential gaps in the current infrastructure. This step may involve upgrading hardware, improving network security, hiring dedicated IT staff, or expanding storage solutions.
Cloud vs. On-Premises: Decide between cloud-based or on-premises solutions based on the site's infrastructure capabilities and security requirements. Cloud-based solutions often offer scalability and lower up-front costs, while on-premises solutions can provide greater control over data security. This is particularly important as it pertains to patient data management laws and regulations in some countries and states. Understanding your regional laws is important if a solution may involve patient data.
Standard Operating Procedures (SOPs): A site should also ensure they have established SOPs in place pertaining to their use and operationalization of any technology or remote service. This will ensure not only a streamlined use across their organization as the technology scales but will also provide a justification to industry when it is used in a clinical trial. SOPs should be developed as a hybridization of both the technology or services used and the current processes at the site to minimize impact and maximize efficient use and rapid implementation. Any technology or remote service that will become regularly used across the organization should be considered eligible for an accompanying SOP.
Maintaining Data Consistency And Streamlining Data Management Processes
Data consistency is vital for ensuring the accuracy and reliability of clinical trial data. Technology solutions should offer features that streamline data management, such as automated data validation, audit trails, and real-time monitoring.
Data Standardization: Implement data standards to ensure uniformity across different systems and data sets. This standardization is critical for data integration and analysis. Consistency is key to long-term and scalable success.
Automated Workflows: Use automated workflows to reduce manual data entry and minimize the risk of errors. Automation can also speed up processes like data cleaning and reporting. If data is consistent and systems are integrated, then data can flow easily to the places where it needs to be collected, reducing duplicate data and information transcription.
How To Measure Success With New Technology Rollouts
Measuring the success of a new technology rollout involves assessing both quantitative and qualitative factors. Key performance indicators (KPIs) may include:
- Efficiency Gains: Reduction in time spent on data entry, monitoring, or reporting.
- Data Quality: Improvements in data accuracy and completeness.
- User Satisfaction: Feedback from site staff and other users regarding ease of use and overall experience.
- Cost Savings: Reduction in operational costs or increased revenue from improved efficiencies.
It is important to first collect these KPIs to measure them both before and after technology implementation. While some solutions may tout efficiency, measuring it is the only sure way to ensure you are getting your ROI. Regularly reviewing these metrics helps sites understand the ROI and identify areas for further improvement.
Final Thoughts On Site Technology Integration, Support, And Evaluation
Integrating new technologies into clinical research sites is a complicated process that requires careful planning, collaboration, and ongoing evaluation. By focusing as an industry on integration, customization, robust infrastructure, and consistent data management, sites can enhance their efficiency and quality. Success in these efforts is measured not only by immediate gains in efficiency and cost savings but also by long-term improvements in data reliability and user satisfaction. Ultimately, the thoughtful adoption and integration of site-facing technologies can lead to more effective and efficient clinical trials, benefiting both researchers and patients. Regularly assessing and refining these processes ensures that sites remain adaptable and responsive to evolving demands.
About The Author:
Jimmy Bechtel is vice president of site engagement for the Society for Clinical Research Sites (SCRS). He is in charge of developing and executing the company's site-facing initiatives and works closely with key industry partners to build out various SCRS partnership programs. Bechtel brings experience from both the site and sponsor sides of the clinical research industry. In his site experience, he served as a data specialist, patient recruiter, and operations manager. In his pharma experience, he worked in innovation project management, encouraging a site-centric environment and creating ease for sites working with a major sponsor company.