SEND Archives

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Generating SEND from Climb™

Instem Team

November 1, 2025

Non-GLP studies that support regulatory safety decisions are required by the FDA to be submitted in SEND, regardless of GLP status. Data collected in Climb™ can be efficiently converted into submission-ready SEND using Instem’s Submit™...

BiotechCROMeet the ExpertsPharmaceuticalPre-ClinicalRegulatory SubmissionRegulatory SubmissionsSENDSEND Advantage Services

Meet the Expert: Rachel Harper, VP Client Implementation & Outsourced Services

Instem Team

September 26, 2025

Outstanding client support is becoming increasingly critical across industries, and the life sciences sector is no exception. As innovation in research and development accelerates, providing clients with expert guidance throughout drug development, study management, and...

BiotechCROPharmaceuticalPre-ClinicalQuality ControlRegulatory SubmissionSENDSEND Advantage ServicesSubmit

A 5-Step SEND Dataset Checklist to Ensure Data Compliance

Instem Team

August 12, 2025

It’s important to consider SEND guidelines throughout the process, not only before submission, to prevent costly surprises.

BiotechCROPharmaceuticalPre-ClinicalRegulatory SubmissionResourcesSENDSEND Advantage ServicesToxicology

Does SEND pave the way for creating Virtual Control Groups?

Instem Team

August 7, 2025

This session will discuss the opportunities for data use beyond submissions, specifically in the area of constructing virtual control groups.

BiotechCROPharmaceuticalPre-ClinicalRegulatory SubmissionSENDSEND Advantage ServicesSensible SEND

Which industry tools are ready for Dataset-JSON v1.1?

Marc Ellison

August 4, 2025

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.

BiotechCROPharmaceuticalRegulatoryRegulatory SubmissionSENDSEND Advantage ServicesSensible SEND

I read all the FDA feedback on Dataset-JSON, so you didn’t have to!

Marc Ellison

July 4, 2025

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.

SEND Blog

Generating SEND from Climb™

Meet the Expert: Rachel Harper, VP Client Implementation & Outsourced Services

A 5-Step SEND Dataset Checklist to Ensure Data Compliance

Does SEND pave the way for creating Virtual Control Groups?

Which industry tools are ready for Dataset-JSON v1.1?

I read all the FDA feedback on Dataset-JSON, so you didn’t have to!

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