What Sites Need: Trial Technology Selection, Buy-In, And Implementation
By Jimmy Bechtel, Society for Clinical Research Sites
As clinical research evolves, the need for efficient, reliable, and integrated technology solutions grows.
Yet the industry is currently experiencing a state of too much technology, with many solutions designed to meet similar needs. This oversaturation, especially for sites, is largely due in part to many technologies not talking to each other and having different platforms required for each study or sponsor. For sites to have scalable operations, decreased costs, and increased trial quality, consistent and integrated technology is needed.
With sites on the front lines, many have created or sourced their own platforms. Technology solutions required or provided by the sponsor or CRO for trials often don’t come with much choice, but sponsors and CROs are more commonly allowing sites to use technology they have built or bought themselves.
Data from the 2024 SCRS Technology Landscape survey (available on the SCRS website or as a recording from the SCRS Global Site Solutions Summit) indicates that the top technologies sites have purchased independently include CTMS, eTMF/eReg, and eSource. Similarly, the top technologies sites are considering purchasing are eConsent, telemedicine platforms, and virtual visit platforms.
However, many sites are still hesitant to adopt their own technologies. Twenty-eight percent of sites are concerned about the cost of technology, 28% are concerned about the lack of integration, and 23% only use what the sponsor or CRO requests.
When adopting new technologies, sites want to support efficient operations, data accuracy, and compliance with regulations. Understanding the process of implementation, selection, and integration of new technologies is crucial to ensure your site runs efficiently with minimal disruption. There are several strategies to help sites select the right technologies to adopt on their own.
Researching, Evaluating, And Budgeting For A New Technology Solution
What are the most important aspects of technology adoption for clinical trial sites? Sites are primarily focused on key areas: researching and budgeting for new technology solutions, securing partner buy-in, integrating with existing systems, customization, infrastructure support, data consistency, measuring ROI, and addressing the varied needs of different technologies.
Selecting the right technology solution begins with comprehensive research and evaluation. This process involves understanding the specific needs of the research site and the types of trials conducted. Sites should consider factors such as:
- Scalability: Can the technology grow with the site's needs? Can it be used in different states or countries?
- Compliance: Does the solution adhere to regulatory standards such as GDPR, HIPAA, and GCP?
- Usability: Is the technology user-friendly for site staff and study participants? Is the interface simple to navigate and intuitive?
- Support and Training: Does the vendor offer robust support and training services? What is the time commitment needed for the training? Which staff members will need to be trained?
- Cost: What are the up-front costs? What long-term expenses need to be considered, such as ongoing maintenance or scaling? What is the return on investment (ROI)?
How To Get Partner Buy-In During Implementation
Gaining partner buy-in is essential for the successful implementation of any new technology. Site staff, investigators, sponsors, and, sometimes, patients must understand the benefits and be convinced of the value the new technology brings.
Start with Communication and Education: Clearly communicate the benefits, such as increased efficiency, better data quality, and improved compliance. Demonstrating how the technology aligns with the overall goals of the site and the specific needs of ongoing or future trials can help in securing buy-in.
Involvement in Decision-Making: Involve key parties in the selection and evaluation process, particularly those directly involved in its use. This inclusion fosters a sense of ownership and helps reduce resistance to change.
Cost Analysis: Beyond up-front costs, consider long-term expenses such as maintenance and IT. Comparing these costs with the expected ROI is essential for financial viability. ROI can be tricky, as many benefits we see with technology aren’t always tangible. For example, time savings is difficult to quantify because it first must be measured. But if sites can get a good sense of tangible and intangible savings, building a case to justify the investment becomes easier.
Testing: Arguably the most important step, conducting a pilot phase can help those involved see the technology in action and assess its benefits and challenges firsthand. This approach provides a practical understanding and can help mitigate concerns. It also allows an assessment of risks or potential roadblocks that a sales representative might not point out or gloss over.
Considerations For Site Technology Selection
Different technologies serve certain functions in clinical trials, and their selection should align with the specific needs of the site and the trial. While most of these strategies will apply universally across technology, some may have different needs and requirements. The major differentiating factor to consider is whether the technology will be patient-facing or not. Patient-facing technology will require a unique set of standards, regulations, and security to ensure patient data remains protected, accurate, and viable. Patient-facing tools could be things like eCOA/ePRO, eConsent, and, in some cases, eSource, while non-patient-facing technologies are typically systems like eTMF and CTMS.
Adopting new technology at the site level is not just about staying current; it's about improving efficiency, data quality, and overall trial outcomes. A well-researched, carefully implemented, and integrated technology solution can transform a site's operations, making it more competitive and capable of delivering high-quality clinical trials. However, this should be done only after addressing the specific needs and challenges of the site and how technology will improve operations. Research sites can better navigate the complexities of modern clinical research and deliver better results for sponsors and patients alike when they take the time to prepare to implement these technologies.
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.