Clinical Trials and CRO

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The one thing you can count on if you do contract clinical trials, or even within a company, is that you’re going to have to configure each one to suit its specific protocols. Few LIMS are up to the task, lacking the flexibility to allow you to set up different tests, workflows, sample types, criteria, etc. That’s where our state-of-the-art cloud-hosted LIMS solution with webLIMS Enterprise edition excels.

Testing and Workflows Specific to Your Lab

In addition to being flexible in your process flows, testing and project setup, LabLynx lets you track all your processes and data by project, ensure the accuracy of your data and access - and share - what you want, when you need it. Your solution can include an online portal for controlled secure access to data, and the data warehouse offers an easy and dynamic way to access any and all results according to specific criteria.

Your LabLynx solution includes support for stability studies, with the ability to auto-generate reminders when a dosage, observation or other event is due.

Coordination and communication with your client(s) are paramount, creating a unified, smoothly-operating study. Some components of that, supported by your LabLynx solution may include coordination and monitoring of the shipment of clinical supplies and/or samples/specimens, reconciling clinical data, ensuring the timely delivery of reports and the resolution of any unexpected issues that occur in a clinical trial.

Compliant with Standards and Regulations That Are Important to You

Of course it's extremely important to be compliant with all applicable regulations and standards when supporting clinical trials, even more so if they involve humans. Here are some of those that can apply, all of which are supported by your LabLynx solution for Clinical Trials/CRO:

  • FDA
    • 21 CFR part 11, 16, 50, 54, 56, 312, 320, 511, 514, 812, 814
  • FDAAA 801
  • NIH
  • OACU (Animals)
  • GCLP
  • CLIA/HIPAA (where applicable)