by Instem Team | Jul 10, 2026 | SEND, Sensible SEND, Study Management
For preclinical data submissions, successful Standard for Exchange of Nonclinical Data (SEND) submissions have moved beyond formatting requirements. As regulatory review becomes more dependent on structured and complete datasets, sponsors and CROs need to think...
by Instem Team | Jul 9, 2026 | Resources
With the FDA announcement that it is no longer a requirement to test on animals prior to human trials; there is potential for a paradigm shift in the conduct of regulatory investigations. This white paper will look at examples on how a simple search in the integrated...
by Instem Team | Jul 2, 2026 | Clinical
Keeping up with regulatory compliance in clinical trials transparency (CTT) is demanding. Sponsors need to navigate overlapping, multi-jurisdictional obligations, each with distinct timelines, data formats, and requirements for confidential information1–3. This...
by Instem Team | Jul 1, 2026 | Resources
Assessing chemical impurity and extractables and leachables (E&L) safety requires integrating mutagenicity screening with systemic toxicity information to support scientifically sound, health-based limits. As regulatory expectations evolve and chemical spaces grow...
by Instem Team | Jun 30, 2026 | Compliance Builder, Quality System Management, Regulatory Submission
In this recap, we’ll cover the challenges associated with 21 CFR Part 11 compliance, the hidden costs of non-compliance, and how Compliance Builder and eQCM help laboratories identify, manage, and close gaps across the full data lifecycle. On Wednesday, June 3, 2026,...
