January 27, 2021
Clinical research, involving data or samples from human participants, drives the development of new diagnostics, therapeutics and preventive measures. It is an essential part of biomedical research and contributes to breakthroughs like the recent COVID-19 vaccines, which were developed in less than a year.
However, any research involving humans is highly regulated to protect the rights and privacy of participants. Clinical research organizations must abide by a number of regulations such as 45 CFR 46 and HIPAA in the U.S. and GDPR in the E.U. Furthermore, clinical research is subject to review and approval from Institutional Review Boards (IRBs). To add even more complexity, clinical research labs must be able to trace the location and use of all data and biological specimens throughout clinical studies.
A Laboratory Information Management System (LIMS) can help clinical research organizations meet their regulatory requirements and follow international best practice standards. With a Clinical Research LIMS, organizations can manage complex datasets, achieve full traceability of all data and biological specimens, control lab inventory, and monitor staff training and protocol compliance.
Clinical research typically involves multidisciplinary teams with complex workflows and many different types of protected data such as informed consent, patient clinical data and genomic data. Therefore, the large datasets arising from clinical research can be difficult to manage without a secure, centralized information management system.
With a LIMS, clinical research organizations can track and manage IRB approvals, ensure staff adhere to approved protocols, and monitor any deviations from validated standard operating procedures (SOPs). Researchers can also manage quality assurance and quality control procedures through their LIMS.
Furthermore, if organizations choose a cloud-based LIMS, researchers in different teams, and even in different countries, can immediately access the most up-to-date research study documents and data, thus preventing unnecessary errors and facilitating real-time collaboration.
Protected health information (PHI) includes any information about the health or healthcare of an individual. If research organizations wish to use this information, they must abide by data privacy regulations including HIPAA and GDPR. Researchers must also obtain informed consent from participants to use their data. Moreover, research organizations must track who accesses the data and how the data is used.
With a regulatory-compliant LIMS, researchers can streamline the informed consent process and follow regulatory rules for managing patient data. If the LIMS is hosted in the cloud, researchers can also share data in real-time with other authorized users. To ensure data security and prevent data loss, researchers should choose a LIMS system that offers advanced data encryption, built-in firewalls, and controlled data access with time stamps and electronic signatures.
Data is only one part of clinical research. Many clinical studies also include biological specimens from human participants, which, like patient data, are subject to strict regulatory control. Regulatory guidelines require a complete chain of custody for all human biospecimens to track them as it is transferred from one custodian to another. Since biological specimens can degrade if not stored and transported in the right conditions, it is important to monitor specimen transport and storage conditions to assure sample quality.
With a clinical research LIMS, researchers can track specimen locations and conditions throughout the sample lifecycle. A clinical LIMS can also streamline specimen collection processes including labeling, annotation and characterization of specimens. Furthermore, it helps in associating specimens with patient data, clinical studies, research documents, kits, quality control results, and in generating custom reports.
Clinical research teams use a variety of lab instruments to generate data. It can be challenging to harmonize different datasets. A clinical LIMS can integrate with instruments, such as DNA sequencers, to automate data transfer, ensuring data integrity and eliminating manual data transcription errors.
Researchers can also choose to integrate their LIMS with data analysis tools, bioinformatics tools, to empower clinical decision making.
Clinical research studies are complex with many moving parts. They can also be expensive and take many years to complete. A LIMS can help research teams optimize their resource utilization by scheduling instrument calibration and maintenance, managing staff training and alerting lab managers when consumables are running low. This helps ascertain that clinical research labs always have the necessary resources in place to facilitate research.
Clinical research studies often involve large teams in several different locations collecting and analyzing protected patient data and biological specimens. A cloud-based, regulatory-compliant LIMS can help clinical researchers manage IRB approvals and study protocols, streamline workflows, keep patient data secure, and track the use of biological specimens. Researchers can also leverage a cloud-based LIMS to share data in real-time. Lastly, a LIMS can integrate with existing lab tools and instruments to automate data collection and help lab managers optimize the use of resources.