As technology continues to transform Clinical Research operations, both research sites and sponsors are investigating ways to leverage this technology to make the most impact on their organizations and research as a whole.
As a technology vendor ourselves, we often hear that organizations are continually approached by new technology vendors entering the market. This constant influx of vendors is not only overwhelming but can be detrimental to your trial operations if the selected vendor’s solution lacks in critical areas of functionality.
The first step to making an impactful technology decision at your organization is understanding the factors at play within the industry, including regulatory bodies, technology vendors, sponsors/CROs, research sites, your peers, and technology innovation at large.
This article captures insights from the Florence Annual State of the Industry Survey conducted in December of 2019. It includes a pulse on where clinical research sites are investing related to technology in 2020.
For the research leader, this article serves as a strategic planning document to ensure your organization is prepared for the coming technology transformation. If you would prefer to download the State of the Industry guide for additional information on this topic and direct insights into results from the survey, please do so here.
Today’s Clinical Trial Site Technology Environment
For the successful implementation of technology at the clinical research site, the external environment must also be accepting and encouraging. Understanding how the external environmental pressures are shaping the direction in which innovation expands will help you prepare for evolving technologies and trends within clinical research.
Three critical factors essential to the evolution of clinical trial site-based technology have emerged in recent months:
Regulatory Bodies Focused on Technology Transformation
Regulatory bodies, often known for hindering technology adoption, are themselves making changes internally to both respond to and encourage the advancement of technology.
This acceleration is apparent when noting that the adoption of ICH GCP E6 Revision 2 took 13 years from Revision 1 – however, the conversations about ICH GCP E6 Revision 3 are already in discussion to account for rapid technological transformation.
The FDA is also actively encouraging the transition to electronic platforms in clinical trials, most apparent in their 2019 Technology Modernization Action Plan (TMAP).
Personal privacy in technology applications became mainstream in 2019 with the adoption of GDPR, CCPA, and other legislation. If you want to learn more about common questions and responses from the FDA, please visit out FDA guide here.
Sponsors and CROs Expecting Site-Based Electronic Platforms
Sponsors and CROs now prefer to work with research sites who have strong internal software platforms.
Direct site access and eTMF integration with site-based platforms are replacing previous trends of trial Sponsors and CROs deploying site portals for document collection.
The efficiency gained from this direct connectivity is now forcing Sponsors and CROs to reevaluate the sites they select to partner with. If you are interested in learning more about the ROI of an eRegulatory system for your site, please visit our resource here to calculate the ROI specific to your organization.
Rapid Growth of Purpose-Built Site Focused Technology Platforms
Vendors, such as Florence, are now building extensive and advanced platforms to serve the clinical trial site.
The key to successfully building your technology infrastructure at your site is to ensure you align with vendors that put the needs of the research site first, solve for its specific challenges and that have an intimate understanding of the day-to-day workflows of site operations team members.
If you want to learn more about our purpose built solutions for sponsors please visit our eTMF page here and for sites our eRegulatory page here.
Five Ways Technology Will Impact Clinical Trials
Technology will transform the clinical trial of tomorrow in numerous ways turning away from antiquated, manual processes, like printing, filing, faxing, and cataloging paperwork, to innovative and automated processes within a digital environment.
These process changes will result in long-lasting and significant improvements within clinical research operations that will transform how research is conducted in the future.
Based on our survey, five of the most significant changes expected in the next three years are:
Faster Study Timelines
Real-time collaboration through integrated technology solutions will enable faster study timelines for clinical trials by reducing lag time between communications, improving task visibility, creating end-to-end workflows and increasing the ability to analyze and immediately adjust processes for efficiency.
Reduced Costs
Streamlined operations and workflows on integrated technology platforms will increase efficiency and decrease cost. Less man hours will be spent completing the same tasks that previously required extensive coordination effort and bared a heavy administrative burden.
Study teams can refocus their energies on increasing and managing study portfolios instead of mundane and repetitive tasks that can now be digitally automated.
If you want to learn what cost reduction may look like at your site after eRegulatory adoption, visit our ROI calculator here.
More Diverse Participant Populations
Remote technology will enable the expansion of clinical trials to more geographically diverse patient populations which historically were not accessible from stationary research sites. Study footprints will expand as this diverse patient population gains access to critical trials and alternative treatments.
Stronger Regulatory Compliance
Automated compliance tracking and security processes will ensure stronger compliance across clinical trial operations. Audit trails and version controls are two ways digitally-enabled sites will have safeguards in place as they maintain the quality of regulatory documentation.
If you want to learn more about compliance for digital systems, visit our article here.
Safer Clinical Trials
Enabling remote monitoring of patients and more real-time data exchange with sponsors will result in safer clinical trials for participants.
Rapid evolution has already begun and with the recent shift to focus on remote capabilities during the COVID-19 pandemic, research organizations are more eager now than ever to find technology solutions that are right for their organization.
To get the full guide on the 2020 Clinical Research State of the Industry Report, including survey stats, the top technologies your peers are considering and how to prepare you research site for technology evolutions – please download the full report here.