The Digital Dilemma: Managing Investigational Medicinal Product Data in a Digital Era

As clinical trials grow in complexity and scale, Investigational Medicinal Products (IMPs) are generating vast volumes of digital records that must be carefully managed, archived, and preserved. Non-compliance with data integrity and retention regulations can lead to delayed approvals, failed inspections, and significant financial loss. 

Welcome to the digital dilemma: how can life sciences organisations effectively manage and preserve Investigational Medicinal Products (IMPs) data in an era of rapid digitisation and increasing regulatory scrutiny? 

What Are Investigational Medicinal Products (IMPs)? 

An Investigational Medicinal Product (IMP) refers to a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial. IMPs can include: 

• New, unlicensed drug substances under development 

• Approved drugs used outside of their authorised indications 

• Reformulated or repackaged products 

• Placebos matching the appearance of the active product 

The Shift from Paper to Digital in Clinical Trials 

For decades, clinical trials relied heavily on paper documentation, from patient consent forms to drug accountability logs. But as trials have become larger, more complex, and global, the volume and speed of data have outpaced what paper can handle. 

In response, the industry has adopted digital systems like Clinical Trial Management Systems (CTMS) and Electronic Data Capture (EDC) systems. These systems now generate vast amounts of high-value digital data, especially around IMPs, capturing every step from manufacture to destruction. 

While digital transformation brings efficiency and real-time oversight, it also introduces challenges. 

The Digital Dilemma: Key Challenges in Managing IMP Data 

1. Data Sprawl Across Systems

IMP data is often stored across multiple platforms and systems, each with its own formats, naming conventions, and metadata standards. This fragmentation makes it difficult to establish a single source of truth and complicates inspections or audits. 

2. Data Format Obsolescence

Many digital files used in clinical trials today (PDFs, CSVs, proprietary lab data formats) may become unreadable or incompatible with future software. Without proactive preservation, vital Investigational Medicinal Product Data risks becoming inaccessible years down the line. 

3. Regulatory Retention Timelines

Investigational Medicinal Product (IMP) data is part of the TMF and subject to long-term retention requirements, with regulatory bodies like the EMA and MHRA mandating archiving for 25 years or more, depending on jurisdiction and trial specifics. Under ICH E6 (R3), these records such as the Investigator’s Brochure (IB), shipping and accountability logs, certificates of analysis, and temperature monitoring records are classified as essential documents because they verify the trial was conducted in compliance with Good Clinical Practice (GCP) and regulatory requirements. Simply storing this data in a file share or live system is not enough to meet these retention timelines.  

4. Inspection Readiness

Regulators expect organisations to produce audit-ready data at any point during or after a trial. Disorganised or inaccessible Investigational Medicinal Product documentation could result in inspection findings, warnings, or even trial rejection. 

A Real-World Scenario: What Happens When IMP Data Isn’t Archived Properly

Imagine a Phase III trial sponsor is contacted five years after study close for an inspection. Regulators request detailed temperature logs, manufacturing records, and accountability forms for the Investigational Medicinal Product. But: 

• The lab system used for temperature tracking has since been retired. 

• PDFs stored in a legacy system are corrupted or unreadable. 

• No audit trail links the archived files to the original trial system. 

The result? Missing data, regulatory delays, and possible inspection findings. This scenario isn’t hypothetical, it reflects a common challenge in today’s digital trial landscape. It reinforces the need for proactive, validated archiving solutions that ensure data integrity, and access over the long term.  

If you’re interested in real-world examples of what regulators look for, this blog on MHRA inspection findings brings inspection issues to life with common gaps in data archiving and compliance. 

Digital Archiving & Preservation: The Solution to the IMP Data Challenge 

To overcome the digital dilemma, life sciences organisations must shift from basic data storage to validated digital archiving and preservation. This means ensuring that data is: 

• Safeguarded – Ongoing data integrity checks throughout the lifecycle of the data. Additonally, providing a route to recovery if a record is found to be corrupted  

• Accessible – Controlled access for users and inspectors, with no vendor lock-in, ensures your organisation retains full ownership and control of the data. 

• Preserved – Active preservation to avoid technical obsolescence ensuring data remains readable, usable, and can be reliably provided during future inspections. 

• Aligned with Regulations– A GxP-validated system designed to support compliance through features such as metadata management and audit trails. A system that can adapt to evolving regulations 

Conclusion: From Risk to Resilience 

As clinical trials continue to evolve in complexity and scale, the management of Investigational Medicinal Product data must keep pace. The shift to digital brings tremendous opportunities for efficiency and insight, but also demands a robust, forward-thinking approach to data preservation. 

By embracing validated digital archiving and preservation strategies, life sciences organisations can transform the digital dilemma into a competitive advantage, supporting data integrity, regulatory compliance, and inspection readiness.