Guest Column | January 15, 2025

Don't Let Poor Lab Operations Ruin Your Clinical Trial

By Nancy Muriithi, clinical laboratory scientist, KEMRI

GettyImages-1569225312 blood sample, lab, testing

As a lab scientist with extensive experience in routine lab operations and quality assurance for clinical trials, I consistently encounter issues that, if unaddressed, could compromise clinical trial integrity. Specifically, I’ve seen that CRAs tasked with monitoring lab activities often lack formal training in laboratory sciences. This lack of specialized knowledge can result in under-monitoring, misdirected focus, and non-adherence to ICH GCP and GCLP guidelines. My observations prompted extensive research on industry standards, case studies, and collaboration across companies and countries, illuminating seven major shortcomings in laboratory practice and monitoring.

7 Major Issues In Clinical Research Laboratory Operations

  1. Insufficient Knowledge Of Regulatory Requirements For Lab Imports And Exports — Many CROs managing multi-country studies lack familiarity with guidelines, required documentation, and timelines for importing and exporting lab consumables and biological samples. This leads to delayed site activation, significant financial losses, strained sponsor-site relationships, and the risk of studies being reassigned to better-prepared sites.
  2. Disorganized Biological Sample Storage Compromising Sample Integrity — Poorly managed storage of biological samples can lead to shipment issues, loss, or damage resulting in invalid test results requiring resampling, increased study costs and timelines, dissatisfaction of study participants, rejection of study data by regulatory authorities, and loss of credibility in front of sponsors and regulators.
  3. Inconsistent Lab Document Archiving Leading To Access And Retrieval Issues — Disorganized filing systems make retrieving critical documents during audits or monitoring visits time-consuming and stressful, producing outcomes such as delays in providing required documents, increased audit findings, damaged reputation in front of regulatory bodies and sponsors, and overall perception of poor operational management.
  4. Noncompliance With Safe And Environment-Friendly Disposal Of Expired Reagents And Consumables — Improper disposal methods for expired reagents and lab waste can endanger both the environment and public health. These issues often lead to regulatory fines and legal consequences, contamination of water sources and the surrounding environment, health crises in nearby communities, and loss of trust of stakeholders and local authorities.
  5. Challenges With Timely Calibration And Maintenance Of Laboratory EquipmentForgetting calibration schedules or lacking documentation for equipment maintenance can trigger significant issues including audit findings, inaccurate results invalidating study data, eroded trust of sponsors and regulators, increased costs for reanalyzing samples, and delays in study timelines.
  6. Insufficient Audit Preparedness And Lack Of Familiarity With Audit ProcessesMany lab staff do not know what to expect during audits, leading to preventable findings. Consequences include delayed responses to findings and queries, strained relationships with auditors and monitors, reduced likelihood of repeated business from sponsors, regulatory warnings, or, in severe cases, study termination.
  7. Challenges In Establishing And Maintaining A Robust Quality Management System (QMS) —
    A poorly implemented QMS often leads to noncompliance with established procedures, resulting in data inconsistencies affecting study outcomes, frequent procedural findings during audits, loss of accreditation and sponsors’ trust, increased operational costs due to repeated errors, and higher risks of regulatory noncompliance.

Addressing Issues In The Lab

When it comes to navigating the regulatory landscape for laboratory imports and exports — one of the seven main issues I identified — precision and up-to-date knowledge are key. To maintain compliance and streamline operations, here are some suggested strategies:

  1. Stay Updated On Regulations — Regularly review and stay informed about local, regional, and international regulations governing lab imports and exports. Subscribe to updates from regulatory agencies or relevant industry bodies to ensure you are always aware of the latest requirements.
  2. Establish A Dedicated Compliance Team — Assign a team or individual responsible for handling regulatory matters. This team should be well-trained in understanding and interpreting import and export laws, documentation needs, and related protocols.
  3. Develop A Comprehensive SOP — Create a detailed SOP for managing imports and exports. Include checklists for required permits, licenses, and declarations to ensure all shipments meet compliance standards.
  4. Partner With Qualified Vendors And Brokers — Work with suppliers, freight forwarders, and customs brokers who are experienced in laboratory goods. Their expertise can help you navigate complex procedures efficiently and avoid unnecessary delays.
  5. Provide Staff Training On Regulatory Requirements — Conduct regular training sessions to familiarize your team with the regulations and documentation required for imports and exports. Ensure that everyone involved in these processes understands their role in maintaining compliance.
  6. Maintain Organized Records — Keep accurate and comprehensive records of all import and export transactions, including permits, invoices, and correspondence. Organized documentation not only ensures compliance but also simplifies future audits and inquiries.

Providing Best Practices In Clinical Research Laboratory Operations

Recognizing the above seven challenges and with the support of many in the industry, I’ve developed resolutions to these challenges in the Guide for Clinical Research Laboratory Monitoring, a comprehensive reference for laboratory monitors, auditors, and quality assurance professionals in clinical research. It serves as a bridge between regulatory standards and day-to-day laboratory operations, helping professionals proactively identify issues, implement effective monitoring practices, and maintain the integrity of clinical trial data.

Future editions of the Guide for Clinical Research Laboratory Monitoring will include automation and digital tools to enhance the efficiency and accuracy of laboratory monitoring practices. Key updates will include the integration of advanced data analytics tools to automate data collection, real-time monitoring, and trend analysis, which will help streamline decision-making and minimize manual errors. I also aim to introduce guidelines for using cloud-based platforms to improve document management, making it easier and more secure to store and access critical lab records. It is imperative for the sponsor to ensure laboratories operate effectively and in compliance with regulatory standards. By doing so, they safeguard the integrity of their clinical trials, protect patient safety, and contribute to the advancement of reliable and impactful medical research

References:

  1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). (1996). Guideline for Good Clinical Practice E6 (R2). Retrieved from https://ich.org.
  2. International Organization for Standardization (ISO). (2015). ISO 9001:2015 - Quality management systems — Requirements. Geneva: ISO. Retrieved from https://iso.org.
  3. International Organization for Standardization (ISO). (2022). ISO 15189:2022 - Medical laboratories — Requirements for quality and competence. Geneva: ISO. Retrieved from https://iso.org.
  4. World Health Organization (WHO). (2009). Good Clinical Laboratory Practice (GCLP): Guidelines for the generation of laboratory data to support clinical trials. Geneva: WHO. Retrieved from https://who.int.

About The Author:

Nancy Muriithi is a Nairobi, Kenya-based laboratory scientist with comprehensive expertise in regulatory affairs, clinical trial monitoring, and laboratory quality assurance. With formal training in laboratory science, she has successfully navigated complex regulatory frameworks and overseen clinical trials, ensuring strict adherence to compliance and quality standards. As a regulatory affairs professional, she has facilitated the smooth progression of clinical research by ensuring that laboratories and trials meet all required regulatory and accreditation standards. As a laboratory quality assurance manager, Nancy has implemented best practices in laboratory operations, data integrity, and continuous improvement. Her multidimensional experience positions her as a dedicated expert in ensuring quality and compliance across clinical research and laboratory environments.