Letters to the Editor
Readers respond to articles and columnists.
eClinical Wish List
The June 2004 article "Meeting the Challenges of Internet-based Clinical Trials" describes the current state of the art of Internet-based clinical trials. Just to ensure that the technologies do not rest on their laurels, the next generation of technology-e-source documents-will truly revolutionize clinical research.
E-source documents will eliminate batch processing of data and almost all manual transcription, the presence of which guarantees an inefficient and error-prone data capture and reporting process.
Here is my wish list for e-source document technology:
- Wireless tablet computer
- Standard eCRF functionality
- Handwriting and voice capture for progress notes
- Real-time optical character, voice recognition, and progress note transcription (in a low-wage country)
- Real-time access to the informed consent form, protocol, investigator's brochure, etc.
- Real-time chat with a medical monitor
- Automatic time reporting (how long do study activities really take?)
- Real-time integration with sponsor's database for sophisticated data validation and queries
While we're at it, it's time to rethink the source document. Using current source documents is like singing a song with the words on one page (the source document) and the notes on another (the protocol). With a combined "scripted source document," we can eliminate a lot of wasted time and errors by integrating step-by-step protocol instructions with data capture fields.
All the technology to implement scripted e-source documents exists today. What are we waiting for?
Norman GoldfarbPresident & CEO
First Clinical Research
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.
