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Bulk/Non-Uniquely Number Kits in a Study

If the Kits in a study are not identified with a unique number (Kit Number), then the study is intended to make use of the advantages of Bulk/Non Uniquely Numbered Kits. This concept of Kits ca…

Labeling Changes & Challenges to Comply with EU MDR

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The introduction of European Medical Device Regulation (EUMDR 2017/745) gives great importance to the end user to assist with the safe and proper use of a medical device(s). The EU MDR and other U…

We are Direct to Subject Ready

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The advantages of the D to S is multi faced for Subjects, Sites, CROs and Sponsors. We recognized the increasing significance of D to S which inspired us the build this features into our system. O…

Clinical Trial Supplies Accountability

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To account all the Supplies of Clinical Trial is a Regulatory requirement. Traditionally people used to use paper based or Excel based tracking of the Supplies. This is tedious, time consuming and…

Digitize Instructions for Use (IFU) to Comply with EU MDR

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The regulation brings digital enablement to the forefront, compelling electronic instructions for use. EU MDR is turning digitization on its head. This new regulation, which goes into effect Ma…