How streamlining informed consent form generation can eliminate weeks from clinical trial start-up
Every drug that makes it to the clinical trial stage requires a variety of informed consent forms (ICF) for study participants. These forms are highly scrutinized by the study’s institutional review board (IRB) and/or ethics committee to ensure the information is clear, understandable, and free of attempts to coerce or influence the participant. The information included on the forms simply must be correct.
The traditional process for creating these informed consent forms requires many time-consuming manual steps by a wide variety of people. Content must be authored, reviewed, formatted, translated, and finalized prior to kicking off the study. Each study site may have specific information to add to the informed consent form provided by the sponsor. Regional variations in language, culture, or healthcare infrastructure may also impact the content.
The variations in informed consent forms from site to site make it difficult to verify, manage, and track changes to all the versions. ICF forms typically vary by:
- Regional variations in word selection, culture, or healthcare infrastructure
- Number of languages the ICF needs to be translated into
- Study logistics and communication instructions
How Leading Pharma Companies Are Transforming ICF Creation
While many pharmaceutical companies struggle with these challenges, some industry leaders revolutionized their approach to informed consent form creation and management.
The key differentiator isn’t bigger teams or larger budgets— it’s a fundamental shift in how the ICF is created, managed, and deployed. Innovative pharmaceutical companies have embraced modern content methodologies that
- Eliminate redundant work through intelligent content reuse
- Ensure consistency across all variants of ICF documents
- Automate formatting and assembly processes
- Maintain complete traceability of all content
- Speed up and reduce the cost of translation
Reimagining the creation of ICFs can accelerate study start-up times and reduce the risk of incomplete or inaccurate information .
A Clear Path Forward for Pharmaceutical Content
If your team is still wrestling with manual ICF processes and the delays they create, there’s good news: a clear path forward exists. Start with targeted improvements to your content creation and management processes.
The most successful transformations share common elements:
- A clear understanding of content components
- Streamlined workflows
- Technology that supports rather than hinders the process
The key is focusing on the human processes first, then enabling them with the right technology.
Take the First Step Toward Faster Clinical Trial Start-Up Times
Our comprehensive e-book, “Informed Consent Forms: A Case Study for Structured Content,” provides insights and inspiration for reimagining your ICF processes .
Drawing on more than a decade of experience helping the world’s largest pharmaceutical companies, this resource provides a clear picture of the risk involved in keeping the status quo and a vision to reimagine your ICF process.
Ready to discuss your specific ICF challenges? Book a 30-minute consultation with our pharmaceutical content experts to explore how structured content solutions can accelerate clinical trial start-up, reduce risk,Don’t let outdated informed consent form processes continue to cost your company millions in direct and hidden costs of R&D. Discover how to transform your approach to ICFs and position your organization for long-term competitive advantage.
