by Instem Team | Apr 16, 2026 | Resources
SEND continues to evolve as regulatory expectations grow and nonclinical research becomes more complex. With SEND 4.0, organizations will face major updates, including new immunology, dermal, ocular, and pathology‑focused domains, as well as structural changes such as...
by Instem Team | Apr 15, 2026 | Quality System Management, Regulatory Submission, SEND
IND Package Preparation Successful IND submissions rely on comprehensive and regulatory-compliant preclinical data, CMC information, and clinical protocol documentation. IND readiness, including SEND documents, is where earlier data quality decisions are rewarded or...
by Instem Team | Apr 8, 2026 | In Silico & Data Insights, Regulatory Submission, Study Management
CMC Readiness CMC (Chemistry, Manufacturing and Controls) readiness is a major hurdle during drug discovery and development. Sufficient, compliant data and documentation regarding the manufacturing process, product stability, and quality controls of a drug are...
by Instem Team | Apr 1, 2026 | In Silico & Data Insights, Regulatory Submission, Study Management
Toxicology Preclinical safety is a crucial aspect of drug discovery. The goal at this stage is to conduct and assess toxicology, safety pharmacology, genetic toxicology, and reproductive toxicology11. Histopathology, clinical chemistry, cardiovascular, and genetic...
by Instem Team | Mar 31, 2026 | Quality System Management, Study Management
Life science organizations must maintain rigorous data integrity and compliance while operating across expanding, often global, environments. Yet many still rely on fragmented document repositories, manual workflows, and disconnected training systems, structures that...
