During the holidays, the FDA released a new Draft Guidance "Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and?Devices Guidance for Industry".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, Inc
数据基础架构与分析
Dedicated to helping small biotech and pharma companies with all ophthalmic data needs.
关于我们
KCTDM is a family run data management and biostat analysis company that provides many services for clinical trials, long term projects, and short term help. Dedicated to helping small biotech and pharma companies, KCTDM specializes in ophthalmology but is not limited to the ocular field.
- 网站
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www.kctdm.com
KCT Data, Inc的外部链接
- 所属行业
- 数据基础架构与分析
- 规模
- 2-10 人
- 类型
- 私人持股
- 创立
- 2004
KCT Data, Inc员工
动态
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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!
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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!
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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!
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