KCT Data, Inc

During the holidays, the FDA released a new Draft Guidance "Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and?Devices Guidance for Industry". Some of the ideas that could affect Data and Data Handling include using reinforcing us the Important/Not Important instead of Major/Minor, differentiating Important/Not Important classification with the subsequent classification of Major/Minor for defining the Per-Protocol Population, reporting all PDs to the IRB, and other items affecting SAEs and PDs. The draft is linked below. Feel free to drop us a comment or message if you have any thoughts or questions about this new guidance! https://lnkd.in/eZaUUG_M

KCT Data has reviewed MedDRA 27.1 and released a short summary of the updates with an Ocular Focus. We do this with every MedDRA update as internal training, and have shared it with clients, contractor, and anyone who may benefit or is interested. If you are interested in receiving a copy, message us or leave a comment!

KCT Data has reviewed MedDRA 27.1 and released a short summary of the updates with an Ocular Focus. We do this with every MedDRA update as internal training, and have shared it with clients, contractor, and anyone who may benefit or is interested. If you are interested in receiving a copy, message us or leave a comment!

We are headed to Chicago for Eyecelerator tomorrow! Be sure to say hi or send us a message if you want to meet. We’ll also be around on Friday!

We are headed to Chicago for Eyecelerator tomorrow! Be sure to say hi or send us a message if you want to meet. We’ll also be around on Friday!

Next month, KCT Data will be in Chicago for Eyecelerator on October 17th and 18th! Be sure to reach out and say hi if you're attending AAO, Eyecelerator, or are in the area. It's always great to reconnect with old contacts and met new people, especially if you have any data management needs we can assist with!

KCT Data attended the CDISC Working Group Meeting this week to advance data standards and to reinforce our expertise in the current standards.

Thank you to everyone who visited our booth at ARVO 2024! Feel free to message us here, if you have any questions or any data management needs, and look for us next year in Salt Lake City, if you need more guitar picks or note pads!

Thank you to everyone who visited our booth at ARVO 2024! Feel free to message us here, if you have any questions or any data management needs, and look for us next year in Salt Lake City, if you need more guitar picks or note pads!