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DDReg Pharma

Data Integrity for In Vivo BABE Studies

The pharmaceutical industry is evolving with technological advancements with a subsequent increase in regulatory scrutiny that emphasizes maintaining the accuracy, completeness, and reliability of data- it has become more critical than ever. Data integrity ensures that information is trustworthy, verifiable, and compliant with regulatory standards. It is essential for safeguarding patient well-being, supporting regulatory approvals, and upholding the credibility of pharmaceutical research. More importantly, in ensures the safety efficacy, and quality of pharmaceutical products. In this context, data integrity refers to the accuracy, consistency, and reliability of data throughout its lifecycle.

In recent years, regulatory authorities have experienced concerns related to data integrity when inspecting various testing sites and study data. For example, the US FDA has observed concerns after inspection of testing, clinical testing, and analytical testing sites as well as during assessment of bioavailability (BA) and bioequivalence (BE) data that has been submitted by applicants. Concerns related to data integrity can affect applications with respect to their filing, review & assessment, regulatory actions, approval, and post-approval activities. Therefore, where possible, regulatory agencies are providing guidance for achieving and maintaining data integrity.

US FDA’s Commitment to Maintaining Data Integrity for In Vivo BABE Studies

At the beginning of April 2024, the US FDA published a draft document on “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” on their website which is made available for comment for 60 days. The aim of the guidance document was to provide applicants with guidance on how to manage, achieve, and maintain data integrity for clinical & bioanalytical parts of BABE studies that have been submitted for INDs, NDAs, ANDAs, BLAs, and supplements to such applications.

“It is each applicant’s responsibility to achieve and maintain data integrity for their studies, which includes identifying and implementing the most effective and efficient risk-based controls. FDA encourages applicants and testing site management to review FDA regulations and all applicable guidance for industry to understand FDA’s current thinking on a topic,” the agency states in the guidance.

Recommendations for Applicants

  1. Testing Site Selection- Choose qualified testing sites with appropriate expertise, resources, and compliance history.
  2. Monitoring and Oversight- Develop strong monitoring plans to assess and control risks to data integrity throughout the study lifecycle. Regular audits are recommended to verify compliance with protocols and regulations.
  3. Documenting Audit Findings- Thoroughly document audit findings and communicate non-compliance or data irregularities to testing site management for prompt resolution.

Recommendation for Testing Site Management

Key actions for testing site management include ensuring the presence of qualified personnel, adequate resources, and clear communication of roles and responsibilities to establish an adequate organizational structure. Additionally, promoting a quality culture by fostering an environment where data integrity is a core value and encouraging personnel to identify and report issues promptly is crucial. Developing and maintaining a robust quality management system to support data integrity efforts, which includes policies, procedures, and training initiatives, is also essential.

Elements of Quality Management System

Throughout the data lifecycle, it is important to have a comprehensive quality management system that maintains data integrity. Some of the key constituents of such system are governance frameworks for guaranteeing data integrity during every stage of the data life cycle from collection to archival and strict record keeping methods involving metadata documentation and adhering to standard operating procedures (SOPs) for collecting and saving information. Furthermore, training personnel on best practices concerning data integrity, regulatory requirements and SOPs is important.

To promote accountability, access controls should be defined so as to restrict personnel access upon their roles while audit trails which capture all changes made on electronic records are used to ensure transparency and accountability. Finally, quality assurance/quality control programs should be put in place in order to identify, address or prevent problems associated with poor data integrity.


Ensuring data integrity is important for safeguarding patient welfare and upholding the credibility of scientific endeavors. Through developing a culture of compliance, implementing robust quality management systems, and adhering with regulatory guidelines, pharmaceutical companies as well as testing site management may confidently navigate the maze of data integrity complexities thereby promoting the development of safe and effective therapies for patients globally. 

DDReg provides regulatory solutions for biotechnology products throughout the entire product lifecycle. With experience of over 120 regulatory agencies and subject matter expertise, DDReg is the go-to-partner for pharmaceutical regulatory services. Read more from the experts: Enhancing Clinical Trial Regulations for Advanced Therapy Medicinal Products