Hello,
The question is very vague, could you please provide more details?
With the limited information, my understanding is LIMS is required only if your lab is managing the samples from Phase 2 study and some analysis (e.g. Bioanalysis). If you are then the system should be validated and fit for GCLP use. (Good Clinical and Laboratory Practices).
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Loganathan Kumarasamy
Senior Consultant
Waukegan IL
United States
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Original Message:
Sent: 06-Apr-2018 10:01
From: Anonymous Member
Subject: LIMS
This message was posted by a user wishing to remain anonymous
Do I need a LIMS system in place for a Phase 2 study? Does it need to be qualified or GMP or ??? Thanks.