An in the Cloud Clinical LIMS to Comply with HIPAA, CLIA, and ISO 15189 Guidelines

A Secure, Compliant LIMS for Clinical Research and Testing Laboratories

A Configurable, Zero Upfront Cost LIMS to Efficiently Manage Clinical Workflows

An in the Cloud Clinical LIMS to Comply with HIPAA, CLIA, and ISO 15189 Guidelines

A Secure, Compliant LIMS for Clinical Research and Testing Laboratories

A Configurable, Zero Upfront Cost LIMS to Efficiently Manage Clinical Workflows

Streamline and Automate Clinical Research and Testing Workflows Using CloudLIMS, a SaaS, in the Cloud Clinical LIMS

Clinical laboratories are a primary source of healthcare data and generate massive amounts of data on a day-to-day basis. Clinical data is crucial for drug discovery, identification of novel biomarkers, disease prognosis, clinical studies, and for providing personalized health care to patients. Clinical laboratories face numerous challenges on a daily basis. These include securely managing biospecimens, patient consent, safeguarding sensitive patient data, managing clinical tests and their results, managing resources, such as personnel, instruments, consumables, besides following best practices and regulatory guidelines such as HIPAA, EU GDPR, CLIA, ISO 15189:2012, GCP, etc.

Seamlessly Follow CLIA and ISO 15189 Guidelines

Safeguard PHI of patients from authorized personnel throughout all phases of the testing process by anonymizing sensitive patient data.

Manage laboratory personnel along with their skills, educational qualifications, and experience. Furthermore, you can track continuous education credit hours of personnel.

Manage records of all equipment used in analytical testing, schedule equipment calibration and perform preventive maintenance as defined by the equipment manufacturer, maintain records of equipment calibration, maintenance, and functional checks performed before use.

Seamlessly manage documents, such as procedure manuals, instrument maintenance manual, 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 personnel.

Advantages of CloudLIMS - A Complete LIMS Software for Clinical Labs

Follow Regulatory Compliance

Follow HIPAA, EU GDPR, CLIA, ISO 15189:2012, GCP, and 21 CFR Part 11

Manage Patients/Subjects

Seamlessly manage patient data, demographic details, and patient consent, as per regulatory and statutory requirements, as well as patients' medical history, to meet ethical and legal requirements.

Manage Specimens

Store annotated specimen data, track specimens using barcodes, print labels, maintain specimen Chain of Custody (CoC), and manage all aspects of specimen genealogy, including aliquots, derivatives, and pooled samples. You can import multiple aliquots or derivatives from a file, and access a complete history of each specimen from accessioning to the final disposal.

Manage Clinical and Diagnostic Tests

Manage clinical and diagnostic tests and their results, maintain test CoC, validate test results, analyze trends based on test results, and generate professional custom test reports.

Instrument Integration

Clinical testing laboratories receive hundreds of samples and generate massive volumes of analytical data on a day-to-day basis. Manual transfer of data from analytical instruments to a LIMS is error-prone and time-consuming. For effective management of growing data volumes and laboratory automation, instrument integration is indispensable. Instrument integration facilitates data transfer from an analytical instrument to a LIMS, thereby eliminating chances of transcription errors, data redundancy, and ensuring data integrity. Furthermore, it helps in automating laboratory workflows, thereby saving time and resources, reducing turnaround times, and enhancing efficiency.

How CloudLIMS Supports Instrument Integration?

CloudLIMS supports instrument integration by the following methods:

CSV/XLS File-based 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 a 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.
CloudLIMS REST API:
CloudLIMS’ REST API can be used by developers to read and write data from/to an instrument for bi-directional data transfer. CloudLIMS REST API is compatible with JSON (JavaScript Object Notation) and XML (Extensible Markup Language) format for data export. For data import to CloudLIMS, the REST API supports JSON format.
Software Integration:
CloudLIMS offers REST API to integrate with third-party software such as EMR, EHR, etc. CloudLIMS also integrates with the equipment involved in tests, such as a blood gas analyzer via CloudLIMS Bridge.

Follow Regulatory Guidelines and Standards

CloudLIMS' Clinical LIMS Software Functionality

Study Management
Manage clinical studies, associate them with samples, patients, and study in-charge, and generate custom study reports. You can also assign permissions to different user groups for each study. You can batch import study records from a file, saving time and eliminating chances of manual errors.

Inventory Management
Manage laboratory inventory such as reagents and other consumables, import inventory records from a file or simply scan barcodes to add new items to your inventory. Furthermore, you can associate each inventory item with samples, patient ID, tests, and edit multiple inventory records simultaneously.

Kits Management
Create kits using pre-defined study-specific inventory templates, design barcode labels for kits and print labels, manage inventory used to create kits and track their shipment. You can import kit records from a file or export kit records in PDF or MS Excel format.

Services & Billing Management
Manage laboratory services such as specimen purchase, storage, and test requests, and create catalogs with defined pricing for each service or package offered by your laboratory. You can also generate invoices or upload invoices generated using any third-party billing software should you choose not to use the invoicing function in CloudLIMS.

What Our Customers Say About Us

"We were looking for a package which would be suitable for tracking samples between different locations, generate barcodes, print labels and set up clinical studies. CloudLIMS enabled this and negated the requirement for large hardware costs – as a new business, this was very attractive. Also being able to update numbers of licences easily on a monthly basis is an advantage to an expanding business and enables us to tailor our contract with CloudLIMS to meet the requirements of our new clients. The support at CloudLIMS is excellent and I am very satisfied with their services."

- Dr. Sue Keeler
Managing Director, Colibri Scientific Ltd.
United Kingdom

Testimonials

Case Studies

A Life Science Company, Fidelis Research Chooses CloudLIMS to Manage Human Tissues, Bio-fluids, and Medical Study Data

Founded in 2012, Fidelis Research, a privately-owned life science company provides high-quality...
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Publications

LIMS in Clinical Trials Sample Management

In the 1980s, during the nascent era of laboratory information management systems (LIMS), major analytical instrument manufacturers figured that producing software to help acquire information...
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LIMS Posters

Managing Human Tissues, Bio-fluids, and Clinical Trial Data at Fidelis Research Leveraging a Cloud Based System

Founded in 2012, Fidelis Research provides high-quality human tissues and bio-fluids specimens...
Learn More >>

White Papers

Effectively Storing and Sharing Biological Data for Clinical Research

Though biobanking—the practice of managing biological specimens and data for current or future medical research—has been around for many...
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An in the Cloud Clinical LIMS to Comply with HIPAA, CLIA, and ISO 15189 Guidelines

A Secure, Compliant LIMS for Clinical Research and Testing Laboratories

A Configurable, Zero Upfront Cost LIMS to Efficiently Manage Clinical Workflows