The following case study using GenAI to create Informed Consent Forms (ICFs) is based on real work conducted between TrialAssure and one of its trusted partners.

The Problem 

Informed Consent Forms (ICFs) are critical to ensure that clinical trial participants completely understand the risks and benefits from participating in a clinical trial. However, creating these documents is often a painstaking process. Manually drafting an ICF can take one medical writer weeks’ worth of time to draft the document, incorporate edits, and run quality checks. This comes at a time when medical writing resources are scarce, and an ICF is needed for every clinical trial.  

As an award-winning, global clinical research organization (CRO), MMS engaged with TrialAssure and its team of AI life sciences experts to find a way to improve efficiencies in document creation, without compromising the high standards that their clients expect. 

The Solution 

TrialAssure and MMS partnered to integrate LINK AI, a cutting-edge AI-powered solution designed to streamline document creation, into the ICF creation process. The collaboration between the two centered on enhancing and configuring LINK AI to meet the unique requirements for ICFs. Key components of this solution included: 

  1. Implementation: TrialAssure engaged a team of MMS medical writers, chosen to become super-users of LINK AI. This team, led by a dedicated project manager, worked closely with TrialAssure to configure the system with the correct scientific acumen and optimized workflows. 
  1. Streamlined Drafting: The LINK AI pilot proved to dramatically reduce the time required to draft ICFs, automating much of the repetitive and labor-intensive work. Powerful features, including a   versatile MS Word AI Assistant  configured for ICFs, enhanced usability and efficiency. 
  1. Overcoming Challenges: Items like metadata in Word documents, which can pose data security risks, were addressed by an automatic scrubbing feature created within LINK AI. Additionally, the tool was enhanced to support both Word and PDF documents, ensuring flexibility and convenience for writers. 

MMS also utilized LINK AI to streamline the creation of other critical documents, including Plain Language Summaries (PLSs) and Plain Language Protocol Synopses (PLPSs), achieving significant time savings across the board. 

The Results 

The impact of LINK AI on ICF creation was transformative! In one scenario, the time to create a draft ICF was reduced by an average of 10 days. In a Medical Writing Functional Service Provider (FSP) engagement where MMS Medical Writers were responsible for supporting a large volume of documents for a Sponsor, this significantly increased overall productivity.  

“TrialAssure LINK AI has redefined how we create Informed Consent Forms. Reducing two weeks of work to mere days has not only saved time and resources but also elevated the quality and consistency of our deliverables. The impact on our team and clients is immeasurable.” 

Alberto Perez-Medina, PhD, Sr. Medical Writer, MMS 

The dramatic reduction in drafting time can grow exponentially for large pipelines. This time saving also translates into substantial quality and delivery improvements for clinical trial sponsors, enabling them to shorten the development cycle and allocate resources to focus on critical program priorities. 

LINK AI ensured consistency and quality across drafts while maintaining the rigorous standards at MMS. By reducing the burden on writers, MMS improved turnaround times for their clients, accelerating clinical trial timelines. Beyond ICFs, the partnership also experienced major efficiencies in other document types, including PLSs and PLPSs. 

For questions regarding the use of GenAI to create Informed Consent Forms (ICFs) or a demo of LINK AI, connect with us here.

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