by Instem Team | Apr 16, 2026 | Resources, SEND
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 13, 2026 | NOTOCORD-hem, Study Management
NOTOCORD-hem is a comprehensive, GLP-compliant software platform for assessing physiological functions across cardiovascular, respiratory, and nervous system applications in nonclinical and life science academic research. With more than 160 advanced modules, the...
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...
