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.

2. Gaps In eTMF Automation

The industry made strides in taming the chaos by providing a TMF Reference Model to help standardize the Clinical documentation filing, with many eTMF solutions on the market today helping do just that. But, the process of classifying, formatting and enriching clinical documentation and metadata 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 to understand highly nuanced and contextual 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 Poor Data Governance

Global shift to standardization via GDP, ALCOA+ and recently updated ICH E6 (R3) brought much needed built-for-purpose procedures, resulting in better data integrity and auditability. This means organizations are upheld to a higher standard of quality when it comes to clinical data and documentation submitted for review. While the review process is becoming increasingly mechanized, the submission preparation process is still largely human-driven and is ultimately error-prone.

Inefficiencies & Delays

Manual documentation classification and metadata extraction and validation is time-consuming, demanding on resources, error-prone and ultimately delays time to market.

Increased Chance of RFT Letters

Varying approaches and training across business units may cause inconsistencies in TMF increasing rework, demand on resources and delays.

Misfiling & Retrieval Issues

Human errors may cause misplaced or incomplete documentation, complicating future retrieval, audits and rejection risk.

Scalability & Cost Concerns

Staff shortages, increased turnover and expertise gaps hinder growth and elevate operational costs.     

up to

90%

reduction in refuse-to-file (RFT) action
due to misclassified documentation or missing metadata.

up to

100%

efficiency gain within 6 months
without growing your team.