Paperless Processes on the Way Out?
Applied Clinical Trials
Survey reveals mixed adoption of paperless data collection in clinical trials, pointing to the need for greater alignment of new eClinical technologies and study conduct.
In January 2014, the FDA presented a webinar “Promoting eSource Data Capture,” to explain its Final Guidance on Electronic Source Data in Clinical Investigations. In a slide, the FDA said the worst case for source data capture is “transcription of data from paper or electronic sources to the eCRF (electronic case report form).” The reason being that there was no intervening paper step needed, less confusion on what is source and the decreased likelihood of data errors.
In April of this year, we conducted a survey with SCORR Marketing to evaluate the paperless trial. In this survey, of 143 respondents, 25% said 0%-10% of their data collection in clinical trials was paperless. The next highest was 22%, who said that greater than 75% of their trials were paperless. And 15% said between 51% and 75% were paperless. So the majority fall in the middle of paperless processes, leaving room for greater adoption in the coming years.
In fact, the majority of respondents-27%-said that in the next three years, 75% to 99% of the processes for clinical trials would be paperless. With the plethora of new technologies surrounding data aggregation, mining, and analytics in all critical areas of study conduct, we can only see that our respondents are correct in their view.
For more information, download SCORR’s free report here.
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
