by Instem Team | Nov 1, 2025 | Climb, Regulatory Submission, SEND, Study Management
Introduction There are occasions where non-GLP studies need to be included in an FDA submission to support a safety decision, and such studies need to be represented in SEND. The agency states this in section 4.1.3.4.1 Scope of SEND for SENDIGs v3.0, v3.1 and v3.1.1...
by Instem Team | Oct 31, 2025 | Pristima, Resources
A leading multinational pharmaceutical and biotechnology company, specializing in medicines and vaccines for immunology, oncology, cardiology, endocrinology, and neurology, selected Pristima to modernize its preclinical research operations. Why They Chose Pristima:...
by Instem Team | Oct 31, 2025 | Resources
Unlock the key strategies to excel in today’s evolving world of electronic quality management. In this white paper, you will gain valuable insights into how modern QMS solutions can transform your operations by: Optimizing Preclinical Processes – See how advanced QMS...
by Instem Team | Oct 31, 2025 | Resources
Achieving and maintaining regulatory compliance is one of the most prominent challenges organizations face today. From meeting ISO and GxP requirements to aligning with 21 CFR Part 11, businesses must navigate complex standards while maintaining efficient operations....
by Instem Team | Oct 30, 2025 | Clinical
For decades, SAS has been the trusted standard for analyzing and reporting clinical trial data, a tool favored by regulators and embedded in every aspect of submission workflows. Yet, the growing popularity of R has brought new possibilities for advanced modeling,...
