Regulatory SubmissionSEND
A 5-Step SEND Dataset Checklist to Ensure Data Compliance
Instem Team
It’s important to consider SEND guidelines throughout the process, not only before submission, to prevent costly surprises.
SEND Blog
Regulatory SubmissionSENDSensible SEND
Which industry tools are ready for Dataset-JSON v1.1?
Marc Ellison
While there are great open-source resources out there, in the nonclinical world, we prefer fully commercially available, supported, validated tools from trusted vendors in the space.
Regulatory SubmissionSENDSensible SEND
I read all the FDA feedback on Dataset-JSON, so you didn’t have to!
Marc Ellison
Marc Ellison, Director, Regulatory Solutions, takes a closer look at the FDA feedback on the new CDISC standard: Dataset-JSON v1.1 as a replacement for XPT files.
Company NewsProvantisSEND
Instem and VICT3R: Pioneering Ethical Innovation in Toxicology Studies
Instem Team
Instem is a contributing partner in the VICT3R Consortium, a collaborative initiative exploring the use of Virtual Control Groups (VCGs) in toxicology studies.
Regulatory SubmissionSENDSensible SEND
When should we start worrying about SEND v4.0?
Marc Ellison
Begin considering the systems that collect and report those data and how they may be connecting to your SEND tools. CROs will have far more data and study types that are now modelled in SEND.
Regulatory SubmissionSEND
SEND: Everything You Need to Know
Marc Ellison
Adapting to these changes can be challenging, but early adoption and thoughtful implementation lead to improved research efficiency.
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