New research focusing on the diffusion of eClinical technology in the study startup phase of clinical trials including: site selection, patient recruitment, contracting and process optimization, application implementation and integration, and outsourcing.
eClinical Technology Adoption and Challenges in Study Startup
The Tufts Center for the Study of Drug Development (CSDD) START II research, completed in 2017, indicated that clinical operations teams "satisfied" with their processes and those outperforming their competitors were adopters of technology.
But what is the extent of this technology adoption in site collaboration? And is this adoption serving as a catalyst for other organizational changes, such as interdepartmental collaboration (i.e., breaking down silos), outsourcing oversight, etc? Or are organizations simply "automating" manual processes without realizing the true operational benefits that technology can bring?
The study comprises data from 262 respondents, 67% pharma and biotech 29% CROs with ~47% of respondents having more than 10 years in clinical development/clinical operations.
Areas examined in the survey include:
- eClinical Technology in Study Startup Usage & Future Deployments
- Barriers to Adopting eClinical Solutions in Study Startup
- Change Management in Study Startup Technology Projects
- Effectiveness of Study Startup Technology Implementations
The research was funded by goBalto, the industry leader in study startup.
Industry Standard Research
"The research shows an industry at the crossroads of change, recognizing the need to modernize its technology and processes to address entrenched bottlenecks in starting clinical trials, but at the same time struggling to break free from incumbent activities.
Despite a battle cry by stakeholders to leverage business intelligence (BI) to guide the initiation of clinical trials, sponsors and CROs are overwhelmingly interested in site information based on their own internal data from prior studies and are focused on internal process optimization and less on comparison against their peers.
The silver lining may come from a renewed focus on change management as the research indicated that specific projects suffered from a lack of executive support or budget for change, with 66% of respondents identifying this as a challenge for adopting new clinical systems."
"We are proud to have had an opportunity to sponsor this research. The results of the study capture valuable data characterizing how those in the industry are engaging and managing their collaborations with investigative sites – the lifeblood of clinical trials.
Perception and reality are quite often at odds and this divergence was seen in the survey results. It's interesting to note that only 22% of respondents are using a Full-Service Provider, whereas 47% are using multiple industry-leading application providers. Interestingly, the biggest challenges cited by organizations that have adopted Full-Service Providers were reporting across multiple applications and integrating multiple applications. These organizations still plan to integrate with other eClinical vendors, which negates the premise of Full-Service Providers currently being espoused to the industry."
The full report is available for download from the goBalto Resource Center.
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