Streamline and Automate Clinical Research Workflows Using CloudLIMS - A SaaS, in-the-Cloud Clinical Research LIMS Software
Clinical research plays a vital role in advancing medical knowledge, disease prognosis, and improving patient care. It encompasses the investigation of new drugs, medical devices, and treatments to determine their safety and efficacy. The data generated from clinical research is critical for developing evidence-based guidelines, improving patient outcomes, and informing public health policies. However, clinical research labs face several challenges, including ensuring the safety and protecting the rights of study participants, complying with ethical guidelines, managing large amounts of data, assuring the quality of results, and recruiting and retaining participants. Clinical researchers must also ensure that their research is conducted in accordance with ICH-GCP guidelines and other relevant standards and regulations to support the validity and reliability of their findings.
A Schematic Representation of a Typical Clinical Research Laboratory Workflow
CloudLIMS - A One-Stop, Purpose-Built Laboratory Software for Clinical Research Labs
CloudLIMS is a scalable, SaaS, in-the-cloud LIMS specifically designed for clinical research labs, CROs, and clinical trials. It supports the data management, automation, and regulatory requirements of your lab, no matter its size or operational complexity. Being in the cloud, CloudLIMS can be accessed anytime, anywhere, is easy to deploy, and enables clinical laboratories to quickly automate without the need to invest in IT infrastructure or personnel, saving time and resources.
CloudLIMS customers have realized benefits in the following ways:
- Meet regulatory guidelines and standards such as HIPAA, US FDA, EMEA, CAP, EU GDPR, ICH-GCP, HTA, GCLP, MHRA, and 21 CFR Part 11 with ease.
- A flexible data model to seamlessly configure and accommodate specific workflow requirements, avoiding costly customization.
- Customizable forms to manage participant data, samples, results, and clinical studies.
- Safeguard the Protected Health Information (PHI) of participants by assigning role-based data access to authorized personnel only.
- Maintain a read-only audit trail to track all laboratory activities along with a date and time stamp.
- Generate custom reports for quick and easy reporting of results to institutional review boards, NHS HSS, and the Clinical Trial Database.
Clinical Research Test Report
Seamlessly Follow Regulatory Guidelines
Safeguard the PHI of participants by anonymizing sensitive patient data and maintain an audit trail whenever PHI is accessed, updated, or deleted.
Manage training and competency records of laboratory personnel and generate staff competency reports. This helps laboratory managers assign tasks only to the personnel with appropriate training, competency, and experience to perform them efficiently.
Manage records of instruments, schedule instrument calibration, and perform preventive maintenance. CloudLIMS helps you maintain calibration and maintenance results, in addition to integrating instruments to load results directly.
Seamlessly manage documents, such as Standard Operating Procedures (SOPs) for sample processing, and ensure document control. You can send documents for periodic review and approval to authorized personnel and ensure that only the latest version of documents is accessible to all authorized personnel.
Advantages of CloudLIMS - A Comprehensive LIMS for Clinical Research Labs
Instrument and Software Integration
Clinical research laboratories receive hundreds of samples and generate massive volumes of data on a day-to-day basis. Manual transfer of data from analytical instruments such as LC-MS, GC-MS, HPLC, spectrophotometers, ICP-MS, NGS, cell counters, ELISA, chemiluminescence immuno analyzer, real-time PCR, digital PCR, end-point PCR platforms, genetic analyzers, and others to a LIMS is error-prone and time-consuming. For effective management of growing data volumes and laboratory automation, instrument and software integration is indispensable. Instrument and software integration facilitates data transfer from analytical instruments and software to a LIMS, thereby eliminating chances of transcription errors and data redundancy and ensuring data integrity. Furthermore, it helps automate laboratory workflows, thereby saving time and resources, reducing turnaround times, and enhancing efficiency.
How CloudLIMS Supports Instrument and Software Integration?
CloudLIMS supports instrument and software integration in the following ways:
- Instrument Integration: CSV/XLS is a standard output file type generated by most analytical instruments. The CSV file mapping enables data to be imported from multiple instruments into the LIMS. CloudLIMS periodically reads instrument-generated CSV files and maps the headers present in the files with the correct fields in CloudLIMS, thereby transferring the analytical data to CloudLIMS seamlessly.
- Software Integration: CloudLIMS offers REST API to integrate with third-party software such as EMR, EHR, and LIS. Furthermore, CloudLIMS can be integrated with statistical data analysis software for downstream data analysis.