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<\/p>\n\nThere is ongoing momentum for the industry\u2019s shift toward digital clinical trials. Although many organizations are considering that transition a long-term goal.\n<\/p>\n
\nOrganizations can apply early lessons learned to facilitate more streamlined study start-up and clinical trial
\nmethodology. Amy Kisken, senior director for study startup at Bayer, shared four ways that
\nsponsors and contract research organizations (CROs) can be more nimble and accelerate their development
\nprograms.\n<\/p>\n
<\/p>\n
\nCompanies have learned that change management cannot be an afterthought, particularly as they\u2019ve
\nimplemented digital methodologies. Clinical trials have seen three seismic shifts within the past two decades,
\naccording to Kisken, and some organizations have been caught off-guard.\n<\/p>\n
\nFirst came the transition from paper-based methods to electronic data capture. The second big shift, still in its
\nearly stages, is the use of risk-based monitoring, which has yet to be optimized and standardized throughout
\nthe industry. The third and perhaps most paradigm-shifting change has been the industry\u2019s adoption of
\ndecentralized clinical trials.\n<\/p>\n
\nCompanies can adjust to these shifts with thorough change management and by facilitating deep-dive
\ndiscussions. By using scenario-based questions they can assess concerns, identify processes to address them,
\nand align stakeholders with new processes.\n<\/p>\n
\nFor example, some organizations were uncomfortable that clinical research associates (CRAs) would not be
\non-site. Kisken noted that, if the concern was around data, they could communicate about
\ntheir layered data review, implement a central data review team, or start targeted medical monitoring. If the
\nconcern was around site relationships, they could implement video calls and virtual tours.\n<\/p>\n
\n\u201cAsking these types of what-if questions can really help individuals identify self-imposed obstacles to adapting
\nto this new reality,\u201d Kisken said.\n<\/p>\n
\nCompanies also learned they need to reassess their study-related processes and basic procedures.\n<\/p>\n
\nFor example, some had already transitioned to virtual site selection, but their site initiation process still involved
\nan on-site component. As a result, they had to adapt those activities that were normally conducted in-person to
\na virtual environment and modify visit reports to ensure that any activities conducted remotely would be
\ndocumented appropriately.\n<\/p>\n
\nAs Kisken pointed out, building flexibility into an SOP equips companies to respond to change and remain
\ncompliant. Along with SOPs, documentation requirements must be reviewed to ensure the faithful capture of all
\ndata, including digital data. In one example Kisken relayed, Bayer discovered a study template had not allotted
\nsufficient space for the advanced digital signature. Although this was a minor detail, it caused significant issues
\nand led to important process revisions.\n<\/p>\n
“Building flexibility into an SOP equips companies to respond to change and remain compliant.”
\nAmy Kisken, Senior Director for Study Startup, Bayer<\/span>\n<\/p><\/blockquote>\n\nOnly when teams went back and examined the rationale for these signatures did they realize that several of them
\nwere not even legally required. The problem disappeared \u2013 and this may be the case for other clinical trial
\nprocesses.\n<\/p>\nConsider system validation and vendor qualification<\/h2>\n
Challenges remain, however. A risk-based approach to validation still requires documentation, even when it is in
\nelectronic form, and not all study team members will be familiar with computer system validation requirements
\nand related processes.\n<\/p>\n\nRaising organizational awareness about system development, and building out from that knowledge, will be
\ncrucial to preventing delays and ensuring that study teams are prepared during trial start-up. Another point to
\nremember is that new technologies will result in the need to qualify new vendors, and teams will need to assess
\nthese needs and budget time for them.\n<\/p>\n
<\/p>\n Platform Benefits<\/h3>\n
\n
- Reduce time spent on qualification and validation<\/li>\n
- Simplify the user experience<\/li>\n
- Improve operations<\/li>\n<\/ul>\n
<\/at-a-glance><\/p>\n
\nBy selecting platform solutions, Kisken noted, companies can reduce
\nthe amount of time they spend on qualification and validation and improve
\nthe user training experience by reducing the number of interfaces they
\nneed to be trained on.\n<\/p>\n\nThe right technology solution can also improve ongoing operations.
\nFor example, during the first year of the COVID-19 pandemic, companies struggled
\nto maintain even a basic level of oversight over various study countries
\nand sites, particularly when pandemic waves affected different regions
\nof the world at different times and severity levels. Even the simple task
\nof knowing which sites were seeing patients and which sites were still
\nrecruiting them was extremely difficult to handle with paper-based
\nrecords. Cloud-based systems allow granular data to be tracked so
\nthat teams can predict roadblocks, even during planning stages.\n<\/p>\nPlan and invest in training<\/h2>\n
\nAs companies assess what they learned, there is real momentum for the industry to push forward with new
\nprocesses and technologies and maintain the efficiencies gained during the pandemic.\n<\/p>\n\nRobust change management practices, and improvements in training and skill building, will be critical to
\nadvancing digital clinical development. Senior management and stakeholders put digitization plans into action
\nalongside robust technologies to reduce investment costs and implementation timeframes.\n<\/p>\n
\n\nThe next few years promise to be exciting times in clinical development, and the industry faces vast
\nopportunities. However, the rules, tools, and processes required for successful digital clinical trials are in flux
\nand will remain that way for some time to come.\n<\/p>\n\nIn the end, it is up to clinical trial sponsors to take full advantage of these opportunities by planning their digital
\nstrategies, and educating workers, not just in the \u201cunit operations\u201d of digital clinical development, but on the
\nwealth of benefits it offers them and the patients they serve.<\/p>\n","protected":false},"excerpt":{"rendered":"Bayer shares four ways that sponsors and CROs can be more nimble and accelerate their development programs.<\/p>\n","protected":false},"featured_media":66773,"parent":0,"template":"","product-link-list":[],"class_list":["post-75925","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry"],"aioseo_notices":[],"aioseo_head":"\n\t\t\n\t\n\t\n\t\n\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t\n\t\t