Contributing Experts at Medrio: Rod McGlashing, Data Science Subject Matter Expert; Melissa Newara, VP of eClinical Solutions and Consulting
As eClinical technologies become more proven, small biopharma organizations and CROs are paying attention to how technology can holistically support their studies.
In fact, a recent survey revealed that in over half of the studies being deployed by respondents, 98% use multiple clinical trial technologies.
In April 2024, BioPharma Dive studioID surveyed 150 people about clinical trial technology, including selection criteria, satisfaction, and utilization. The results highlight key insights into the growing importance of technology as studies get more complex.
Small biopharma companies and CROs are embracing technology in clinical research.
While there is confidence that current technology is helpful, there is some doubt about how it will stack up against future research complexities. Here’s what to know.
Curious about which tools small organizations value most? Download the eClinical Technology Trends Survey Report.
Clinical Trial Technology Uptake in Phase I and Phase II
Among people using eConsent or EDC, 100% said they introduced those solutions in Phase I and II. According to the survey, solutions introduced early tend to support study operations, data management, or other foundational activities.
Technology introduced in Phase I and Phase II:
- Electronic Consent (eConsent): 100%
- Electronic Data Capture (EDC): 100%
- Electronic Trial Master File (eTMF): 98%
- Electronic Patient Reported Outcomes (ePRO): 75%
- Randomization & Trial Supply Management (RTSM): 71%
- Electronic Clinical Outcome Assessments (eCOA): 67%
- Clinical Trial Management System (CTMS): 58%
- Imaging: 54%
The value of using eConsent in early phase trials
In the past, many companies stuck with paper consent in trials with smaller participant numbers or Phase I studies. This hesitancy might be due to concerns about the upfront costs of implementing eConsent.
However, more companies recognize the true cost of paper processes.
“It is surprising that we see eConsent being introduced so early, as we usually see these solutions implemented in later stages,” says Melissa Newara, VP of eClinical Solutions and Consulting at Medrio. “But it is certainly promising to see that the value of this tool is gaining more widespread attention.”
Implementing eConsent early on provides significant value. It ensures data completeness and accuracy while streamlining informed consent processes.
Learn more about Medrio’s eConsent solution here.
The importance of including RTSM early
RTSM can benefit studies of all sizes and phases. Based on the survey results, more companies are recognizing the value of implementing a single, unified platform.
The right RTSM can manage the entire supply chain from end to end, using automation and cloud-based systems. Optimizing the clinical trial supply chain can improve an often overly complicated, error-prone process.
Implementing RTSM early on can enhance oversight of incidents, accountability, returns, and destruction while eliminating duplicate data entry and reconciliation.
Learn more about Medrio’s RTSM solution here.
The impact of eClinical technology on biopharma companies in oncology
Recently, emerging biopharma companies have led innovation in oncology. Given the rapid changes in cancer research, oncology researchers need the right technology to effectively and securely collect clinical data in early-phase oncology trials.
Oncology trials need a system capable of supporting the following:
- Rapid adjustments due to protocol amendments
- Real-time error checking
- On-schedule studies
While many technologies can be used in an oncology trial, employing a CDMS, also known as an EDC system, can set researchers up for success in building faster, higher-quality trials.
Learn more about Medrio’s CDMS/EDC solution here.
Clinical Trial Technology Uptake in Phase III and Phase IV
Meanwhile, solutions that tend to support large numbers of participants are more likely to be introduced in Phase III and IV.
These eClinical solutions include:
- Wearables: 85%
- Risk-based quality management (RBQM): 74%
- Telemedicine: 64%
The value of RWD and RWE in late-phase clinical research
Between 2020 and 2022, the number of Phase IV trials using insights from the real world more than doubled. Real-world evidence (RWE) will increase in importance as sponsors work to elevate the participant’s voice in clinical research.
Sponsors are tapping into wearables, electronic health records (EHRs), questionnaires, claims, genomics, and beyond to gather more real-world data (RWD) and gain new insights. This real-world data can be integrated into a Phase IV study and then turned into real-world evidence.
Learn more about RWE. Download our eBook “Real-World Evidence and Phase IV: Making Enrollment and Engagement Work at Scale.”
eClinical Technology Supports Data Quality
High-quality data is required for a clinical trial to pass regulatory inspection and move to the next phase or receive approval.
So, it makes sense that survey respondents overwhelmingly selected “increased data quality” as a top benefit of clinical trial technologies. Companies also prioritized efficiency-related factors such as “decreased cycle time” and “decreased labor costs.”
Biopharma and CRO stakeholders seem most excited about improvements in data reliability—which they reported as a top future tech benefit. This insight aligns with what respondents reported about data quality and emphasizes the importance of data for years to come.
Learn how Roche Diagnostics uses technology to maintain quality clinical trial data.
How does an Electronic Data Capture (EDC) system support data quality?
An EDC is a study’s clinical database of record. The right EDC system helps sponsors build faster, more robust trials.
EDC systems accommodate the growing complexity and speed of clinical research. They support efficient, high-quality clinical trials. These systems speed up study build timelines, improve data quality, and maximize operational efficiency.
Check out Medrio’s EDC Buyers Guide here.
Confidence About Current eClinical Platforms
The BioPharma Dive studioID survey asked about respondents’ confidence in their organization’s existing clinical trial technologies. Most respondents expressed confidence in their current tech stack.
When asked if their tech stack could keep pace as clinical trials evolve in the future:
- 21% said they are very confident
- 71% said they are somewhat confident
- 8% said they are somewhat unconfident
“The industry’s proven ability to be nimble and adapt during the pandemic instills lasting confidence in our future,” says Rod McGlashing, Subject Matter Expert of Data Science at Medrio.
As far as future benefits of using technology in clinical research:
- 47% hope it will offer improvements in data integrity
- 39% are looking for its support in selecting sites
- 38% hope tech will help them with data security
Clinical Trial Technology Trends Impacting The Future
Even though leaders seem happy with their technology, certain doubts chip away at their confidence.
People who responded to the survey expect trial technologies to evolve as studies do. However, they also doubt how well the tools will perform key future tasks.
Respondents were least confident that solutions could support emerging complexities and trends like synthetic control arms and decentralized trials.
Melissa attributes these perceived gaps to a bigger, broader concern. “I think a lot of organizations are still working through what things like synthetic controls, digital twins, decentralized clinical trials, and other trial complexities mean for them and their research,” she said.
Biopharma and CRO leaders may be having doubts about whether they can evolve their strategies to support trial complexities, not necessarily whether the technology will support them.
This article only captures a few of the insights from the Clinical Trial Technology Trends Report. You can download the entire report to learn more about what decision-makers think about current vendor support, where major challenges arise, and more.
