How Information Governance Can Help Biotech Companies Promote Successful Clinical Trial Management

Biotech companies conducting clinical trials face significant data management challenges due to the volume, complexity, and regulatory sensitivity of the information they handle. Many firms struggle with fragmented records, leading to delays and inefficiencies. Adding to this complexity, many employees (in all types of firms) find their organization’s records management systems confusing and ineffective. This is a critical issue in clinical research, where poor data management can jeopardize regulatory approvals and patient safety. And, where the stakes of poor data are higher than for most other industries.

The Risks of Poor Clinical Trial Records Management

Biotech firms face significant financial, operational, and compliance risks when clinical trial records are mismanaged. Incomplete or missing records can result in regulatory delays, rejected submissions, and costly remediation efforts. The Tufts Center for the Study of Drug Development estimates that each day of regulatory delay costs biotech firms over $500,000 in lost revenue potential, making record management failures an expensive risk.

Beyond financial losses, disorganized records contribute to and exacerbate compliance violations. Recent FDA enforcement actions have resulted in multi-million-dollar fines due to non-compliance with clinical trial record-keeping requirements. Poor documentation practices also pose direct risks to patient safety, leading to critical errors such as incorrect dosage administration and incomplete adverse event reporting.

One of the biggest contributors to these challenges is the vast and ever-increasing mess caused by Redundant, Obsolete, and Trivial (ROT) data—information that no longer holds business or regulatory value. Studies indicate that, for a typical company, 69% of organizational data falls into this category, including outdated trial protocols, expired consent forms, and redundant system logs. Retaining unnecessary data inflates storage costs and hinders regulatory compliance by making it harder to locate critical records. Regulatory audits often cite poor data organization as a major deficiency, increasing the risk of compliance failures. Additionally, human errors caused by misfiled or incomplete records account for 25% of compliance failures in clinical research.

To mitigate these risks, biotech companies must implement robust information governance (IG) practices that ensure clinical trial records are well-organized, accessible, and compliant with regulatory standards.

And, one of the most important mitigation steps to fix some of the key misunderstandings about records management obligations.

Here we go…

Key Misunderstandings About Records Management Obligations

Adding to the risk, biotech firm management can tend to have misconceptions about their records management obligations. Here are some of the big ones:

• "We Only Need to Keep Records for a Few Years" – Clinical trial records must often be retained for at least 25 years in the EU and two years after marketing approval in the U.S.

  
  

• "Electronic Records Eliminate Compliance Issues" – Digitization alone does not ensure compliance. Both FDA and EU rules require electronic records to be validated, tamper-proof, and subject to audit trails.

  
  

• "Our CRO Handles Everything" – While Contract Research Organizations (CROs) manage trial operations, biotech firms remain legally accountable for compliance – and, when errors occur, they usually end up with the liability!

  
  

• "All Records Must Be Kept Indefinitely" – Keeping all records beyond retention periods increases costs and non-compliance risks, such as the right to be forgotten embodied in many comprehensive privacy regulations and other similar rights provided in sectoral laws related to protected health information.

  
  

• "Regulatory Agencies Only Care About Final Reports" – This is not true. Regulators often need to know the basis for the report findings and frequently request raw data, site documentation, protocol deviations, and communications.

  
  

• "Cloud Storage Ensures Compliance" – Not all cloud solutions meet stringent GxP validation requirements, leading to compliance gaps. And not all employees are properly trained in how to safely use cloud storage systems!

  
  

• "We Don’t Need a Formal Information Governance Policy" – Lack of standard IG policies results in inconsistent data handling, making audits more difficult.

  
  

Implementing Information Governance to Streamline Clinical Trial Records

Applying information governance (IG) best practices provides biotech companies with a structured approach to overcoming clinical trial records management challenges. Key strategies include:

• Standardized Metadata and Taxonomy Frameworks: Consistent metadata structures improve record searchability, streamline regulatory submissions, and enable interoperability between clinical trial management systems (CTMS) and electronic trial master files (eTMF). Organizations using structured metadata can reduce document retrieval times by up to 50%, expediting regulatory responses and trial monitoring activities.

  
  

• Automated Data Retention Policies: Implementing automated retention schedules ensures compliance with record-keeping mandates, such as the EU’s 25-year requirement for clinical trial data, while systematically removing obsolete data. Companies with mature retention policies experience significantly fewer compliance-related delays.

  
  

• Centralized Search Platforms: Consolidating trial records into a single, integrated search platform improves accessibility and collaboration between research teams, sponsors, and regulators. Studies show that enterprise search tools reduce record retrieval times by 30-50%, enabling faster responses to FDA and European Medicines Agency inquiries and minimizing costly trial delays.

  
  

By addressing these challenges and implementing IG best practices, biotech companies can strengthen compliance, reduce risk, and improve clinical trial efficiency.