A Configurable, Zero Upfront Cost Clinical Diagnostics LIMS

A Secure, Compliant LIMS for Clinical Research and Diagnostic Laboratories

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

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.

A Schematic Representation of a Typical Clinical Testing Laboratory Workflow

Generating Certificates of Analysis (CoA)

CloudLIMS- A One-Stop Clinical LIMS Software

CloudLIMS is a purpose-built, scalable, SaaS, in the cloud clinical LIMS. It grows with your clinical laboratory by supporting your data management, automation, and regulatory requirements. With a cloud solution, the clinical LIMS 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.

CloudLIMS customers have realized benefits in the following ways:

Meet regulatory guidelines and standards such as HIPAA, EU GDPR, CLIA, GCP, ISO 15189:2012, and 21 CFR Part 11.
A flexible data model to seamlessly configure and accommodate specific workflow requirements avoiding costly customization.
Customizable forms to manage patient data specimens clinical and diagnostic tests and their results clinical studies and kits.
A self-serve client portal to deliver test reports and invoices to your customers in real-time.
Safeguard PHI (Protected Health Information) of patients by assigning role-based patient data access to authorized personnel only.
Maintain a read-only audit trail to track all laboratory activities along with a date and time stamp.

Clinical Test Report

Seamlessly Follow CLIA and ISO 15189 Guidelines

Ensure Confidentiality of Patient Data

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

Manage Lab Personnel Requirements

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

Manage Equipment and Ensure
their Proper Functioning

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.

Manage Documents

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.

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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 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.

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.

Instrument & Software 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 and software integration is indispensable. Instrument and software integration facilitates data transfer from analytical instruments and software to a LIMS respectively, 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.

Instrument-Integration-Clinical-with-bridge-2

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 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.
Software Integration: CloudLIMS offers REST API to integrate with third-party software such as EMR, EHR, LIS. Furthermore CloudLIMS can be integrated with medical or clinical billing software to effectively manage revenue cycles and minimize billing errors enhancing customer experience.

Follow Regulatory Compliance

Scientific Advisors

Dr. Carolyn Compton

Professor of Life Sciences, Arizona State University Carolyn Compton

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data-privacy-and-other-clinical-data-management-challenges

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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 and 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.

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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

"CloudLIMS has become an integral part of our clinical diagnostics and COVID-19 testing. The CloudLIMS team made sure we had everything set up for running our operations smoothly. They provided the templates to help us meet the reporting requirements for COVID-19. Their batch report processing helped us save time. Moreover, we receive outstanding support at all times!"