What’s wrong with the way that most sites have been recording data for decades?
While much of research data is still being collected on paper, digital adoption across source, regulatory and remote monitoring is rapidly increasing among sponsors, CROs, and research sites. Many of the challenges that Principal Investigators (PIs) face during the conduct of clinical trials stem from the requirements of ICH-GCP guidelines, regulatory requirements – and the overall meticulous nature of clinical trials. But, partnered with the right software solution, it is possible for sites and PIs to build better oversight throughout clinical trials.
“Decentralized trials are the rage and many vendors are getting large infusions of capital on the premise of transforming research. Undoubtedly, more at-home visits will be offered, and more patients will be sourced through digital campaigns and EMR data mining tools,” says Raymond Nomizu, CEO and co-founder at Clinical Research IO (CRIO). “That said, we’re convinced that nearly all interventional trials will continue to rely on local PIs for study oversight – and that an integrated platform at the Investigator level is needed to meet the moment.”
Here are 3 reasons why the industry’s best PIs have been leading the switch to eSource.
1. The digitization of source data: future-proofing your site
Where and how data is recorded matters. PIs are on the hook for safeguarding and maintaining data, therefore reliable audit trails are a necessity for ensuring data integrity. eSource is a solution that creates digital audit trails, which are more reliable and easier to maintain than paper. CRIO eSource, for example, protects data from start to finish by ensuring the highest possible data quality with built-in compliance across 21CFR11, ICH-GCP, GDPR, HIPAA, and other global regulations.
As we continue to transition and adapt to the ever-evolving effects of the pandemic, digitization is now an essential part of the trial process, and a crucial link between sponsors, CROs, and sites. Tech adoption was accelerated during COVID-19 to address disruptions to site access – and the pivot to technology is becoming the new normal. Most importantly, PIs and site management must now be prepared to lay an evolved groundwork for site success, or risk being left behind.
2. The adoption of technology beyond strict lock-downs: a new normal
A recent CRIO Post COVID-19 Site Survey revealed that 45% of sites surveyed adopted new technology in response to the pandemic and 70% of those sites planned to keep all their newly adopted systems – even after the lifting of strict social distancing and quarantine policies.
Benefits of eSource
- Alert logic removes duplicate entries
- Improve PI review/ approval process
- Reduce administrative burden on sites
Regulators have been urging the use of eSource for over a decade. But, research shows that a delay in adoption can be attributed to both real and perceived difficulties in operationalizing the technology at the site level. Certainly, site teams should not be burdened with training sites on new platforms, migrating data, and setting up study designs on their own. And with the right partners, you won’t have to.
3. One size doesn’t fit all: operationalizing eSource at your site
Every site operates differently, so if you’re ready to upgrade and digitize your site, one of the keys to success will lie in your vendor selection. Your software provider is a partner who can better help you if they have an organic understanding of your pain points. With this insight, they’re more likely to deliver a product that’s customizable, enables easy workflows, and can scale with you as your site grows.
CRIO is built for sites by a former site owner. We incorporate site feedback into our product development and enhancements to ensure that our software suite meets the unique needs of each site. CRIO’s fully stacked software solution is designed to support flexible workflows that allow each site to set up unique structures to replicate existing processes.
We know that sites have limited resources for extensive self-training, self-certification, and self-onboarding processes. That’s why CRIO offers multiple ways to learn. CRIO supported sites take advantage of robust site implementation, onboarding and training capabilities.
Experience the difference: a platform that users love
Execute your study protocol with surgical precision using CRIO’s eSource, CTMS, and eRegulatory. 2000+ investigators across the globe who use and love our system can’t be wrong. Team CRIO gets users up and running fast on a platform that sites trust, backed by our industry-leading customer success team. Is CRIO right for you? Let’s connect to explore how CRIO helps ensure better data integrity and better oversight.