by Instem Team | Jun 9, 2026 | Resources
Recent FDA communications have made clear that poor-quality SEND data can trigger rejections, information requests, and costly submission delays, making robust verification and traceability essential. Managing SEND conversion in-house places significant burden on...
by Instem Team | Jun 2, 2026 | Resources
Pharmaceutical and biotechnology laboratories depend on a wide array of analytical instruments, each operating as an independent data environment with its own file storage, user access controls, and audit trail configurations. Without centralized governance across...
by Instem Team | Jun 2, 2026 | BioRails, Study Management
Drug discovery research is extraordinarily data-heavy. A single program can generate vast amounts of diverse data over months and years, and incorporate a range of assays performed across multiple teams and organizations. Traditional methods for handling data are not...
by Instem Team | May 29, 2026 | Compliance Builder, Regulatory Submission, Study Management
Somewhere in a quality control laboratory, a chromatography system finishes a run and saves its output to a local workstation drive. The analyst moves the file to a shared folder, exports results to a spreadsheet, and closes out the session. It is a routine action,...
by Instem Team | May 22, 2026 | Company News, SEND, Study Management
Three days in the heart of Boston for Instem Interact. Three days of insightful sessions, conversations, and collaboration, and in the words of our CEO Vik Krishnan: “Three days I genuinely believe will push our community forward.” Built around the themes...
