In drug discovery and development, data integrity and regulatory compliance are fundamental to successful progression from early research to regulatory submission. Regulatory authorities increasingly scrutinise not only study outcomes, but also how data is generated, managed, and controlled throughout its lifecycle. As a result, Central Laboratory Services (CLS) play a critical role in ensuring that non-clinical and clinical data meets regulatory expectations.1
By centralising testing activities and embedding quality, traceability, and standardisation into laboratory operations, CLS providers help sponsors generate regulatory-ready data that is reliable, reproducible, and auditable.2 This blog explores how central laboratories support data integrity, and why their workflows, quality systems, and digital infrastructure are essential for regulatory submissions.
Why Data Integrity Is Central to Regulatory Compliance
Regulatory agencies such as the FDA, EMA, and MHRA define data integrity as the completeness, consistency, and accuracy of data across its entire lifecycle. This includes raw data, metadata, analytical processes, and any changes made to records over time. Regulators expect all data supporting regulatory decisions to comply with the ALCOA+ principles, ensuring it is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available.3
Failure to demonstrate data integrity can result in inspection findings, delays to regulatory approval, or rejection of submitted data. For this reason, maintaining data integrity is not an administrative exercise but a core component of regulatory compliance. Central laboratories are specifically structured to meet these expectations by controlling data generation from the earliest stages of a study.
Standardised Workflows Reduce Variability and Risk
One of the primary benefits of working with a central laboratory is the implementation of standardised and validated workflows. Variability in sample handling, assay execution, or data processing can compromise data quality and undermine confidence in study results, particularly in multi-site or longitudinal studies.4
Central Laboratory Services address this challenge through harmonised standard operating procedures, validated assay methods, and controlled staff training. By ensuring that samples are processed consistently and methods are applied uniformly, central laboratories reduce technical variability and improve reproducibility. From a regulatory perspective, standardised workflows strengthen the scientific credibility of the data and simplify its assessment during regulatory review.
Quality Control and Quality Assurance Built Into CLS Models
Robust quality control (QC) and quality assurance (QA) frameworks are integral to Central Laboratory Services. These systems are typically aligned with regulatory standards such as GLP, GCP, and ISO guidelines, and are designed to ensure that data is generated in a controlled and compliant environment.5
QC activities verify that instruments, systems, and assays perform as intended, while QA provides independent oversight of processes, documentation, and data outputs. This layered approach ensures that deviations are identified, investigated, and documented appropriately, with corrective actions implemented where necessary. For regulatory submissions, QA oversight provides assurance that reported results are supported by traceable raw data and compliant laboratory practices.
Audit Trails and Digital Systems Enable Full Data Traceability
As regulatory expectations around electronic data continue to evolve, audit trails and secure digital infrastructure have become essential components of data integrity. Central laboratories commonly employ validated laboratory information management systems (LIMS) and electronic data capture platforms to maintain full traceability throughout the data lifecycle.6
These systems create time-stamped records of data generation, modification, and review, clearly documenting who performed each action and when. This level of transparency is critical during regulatory audits and inspections, where inspectors may request access to raw data, historical records, or evidence of procedural compliance. Centralised digital systems allow CLS providers to respond efficiently and confidently to these requests.
Supporting Regulatory Submissions With Confidence
Data generated through Central Laboratory Services is inherently better suited for regulatory use. The integration of standardised workflows, embedded QC and QA, and comprehensive audit trails results in datasets that are consistent, reproducible, and aligned with regulatory guidance.
For sponsors, this reduces the risk of regulatory queries, inspection findings, or requests for additional data. It also streamlines submission preparation by ensuring that compliance considerations are addressed during data generation, rather than retrospectively. As regulatory scrutiny continues to increase, this proactive approach to data integrity is becoming increasingly important.
Central Laboratory Services as Strategic Partners in Drug Development
Central Laboratory Services have evolved from transactional testing providers into strategic partners in regulatory-compliant drug development. By embedding data integrity, quality systems, and traceability into everyday laboratory operations, CLS providers support informed decision-making from early discovery through to regulatory submission.
At REPROCELL, our Central Laboratory Services are designed to generate data-rich, disease-relevant, and human-relevant data, underpinned by robust quality frameworks and a deep understanding of regulatory requirements. By prioritising data integrity at every stage, we help our partners advance their programmes with confidence in the data supporting regulatory decisions.
References:
1. “Unlocking Clinical Trial Success: 5 Things to Consider When Selecting a Central Lab Partner.” LabConnect, www.labconnect.com/07-29-25-five-considerations-when-selecting-central-lab-partner.html. Accessed 23 Jan. 2026.
2. Linda Bunschoten - Chief Marketing Officer. “Ich E6(R3) Sponsor Responsibilities: Key Updates Explained.” Cyntegrity, 8 Jan. 2026, cyntegrity.com/ich-e6-r3-sponsor-responsibilities/.
3. Pharmaguideline. “Importance of Data Integrity for Pharmaceutical Regulatory Agencies.” Pharmaguideline, 8 Dec. 2025, www.pharmaguideline.com/2025/04/importance-of-data-integrity-for-regulatory-agencies.html.
4. Kandi V. The advantages of working with a central laboratory for conducting clinical trials. Bioanalysis. 2024 Dec-Dec;16(23-24):1207-1209. doi: 10.1080/17576180.2024.2424126. Epub 2024 Nov 18. PMID: 39555573; PMCID: PMC11703448.
5. “Quality Assurance Framework Principles of QA of Analysis May 2025.” Department for Education , assets.publishing.service.gov.uk/media/68232aa67b63976092644a65/Quality_assurance_framework.pdf. Accessed 26 Jan. 2026.
6. Boyar, K., Pham, A., Swantek, S., Ward, G., Herman, G. (2021). Laboratory Information Management Systems (LIMS). In: Opie, S.R. (eds) Cannabis Laboratory Fundamentals. Springer, Cham. https://doi.org/10.1007/978-3-030-62716-4_7
