1. Incomprehensible Volumes
Organizations managing clinical trials are tasked with an enormous endeavor to bring order to millions of documents, spanning 300+ nested categories, which is critical for a new drug submission to regulatory bodies, such as the FDA.
.png?width=55&height=55&name=earthquake%20(1).png)
2. Gaps In eCTD Automation
The industry made strides in taming the chaos with robust RIM solutions on the market today. But, the process of classifying, formatting and enriching clinical & regulatory documentation is still a human-centric process.
3. Difficult to Transfer Knowledge
AI models have been getting increasingly more intelligent over the recent past. But they were not smart enough yet understand highly nuanced and contextualized clinical documentation workflows reliant heavily on unstructured data. Up until now, bringing order to clinical data has only been achieved by human professionals with large expertise in this field.
4. No Room For Technical Errors
Global shift to standardized eCTD format helped bring much needed efficiency to the approval process, which also helped automate submission's technical format review. This means there is no room for error in file naming conventions, font sizing, document navigation, date formats, and other technical requirements. While the review process is mechanized, the submission preparation process is still largely human-driven and is ultimately error-prone.
New to Adlib?
Signup and we'll be in touch vial email with instructions on next steps.
Already a client?
Great! You're already familiar with Adlib, your input will help shape our future growth. We can't wait to see your idea seeds!
Are you an Adlib partner?
This means you have experience with Adlib technology! Let's see what we can grow together!
