Following the FDA’s recent announcement expanding flexibility in preclinical submission evidence, Instem is reaffirming its role as the industry’s trusted provider of an end-to-end preclinical platform - empowering life sciences organizations with the tools, insight, and scientific depth needed to thrive in an increasingly dynamic regulatory environment.
While many view this shift by the FDA as a new direction, Instem sees it as a natural progression of the transformation Instem has been advancing for years with clients around the world.
“We are not surprised and are very supportive of the FDA’s direction,” said Vik Krishnan, CEO of Instem. “This has long been the trajectory: traditional in vivo research studies are here to stay, but this latest development supplements these proven methods with more predictive, flexible, and data-driven approaches. Instem is uniquely positioned to help clients adapt - not by replacing what works, but by expanding what’s possible.”
Instem is a stronger partner now more than ever in this evolving landscape because its solutions address:
- Study Management - Instem’s platform supports both traditional and New Alternative Methodologies (NAMs), including GLP and non-GLP workflows, flexible modular study designs, and advanced planning tools for complex preclinical programs.
- In Silico - Instem offers predictive modeling capabilities and analytics that empower clients to explore mechanism-based alternatives and inform early decisions, reducing reliance on in vivo testing.
- In Vitro – Instem’s platform enables seamless integration of laboratory data from in vitro experiments, with structured capture, analysis, and visualization across diverse non-traditional modalities.
- Regulatory Submission - In this emerging world of mixed-method evidence, Instem’s Submit suite is more essential than ever - providing robust, compliant pathways for structured submission and SEND generation across varied evidence types.
Instem’s platform enables global sponsors and CROs to confidently plan, execute, and submit preclinical studies, ensuring scientific rigor and regulatory readiness at every step.
Instem is also an active member of the VICT3R consortium, driving innovation in regulatory toxicology through Virtual Control Groups and advanced data science.
“Our mission hasn’t changed,” added Krishnan. “Our mission is to help our customers make discoveries, and to accelerate and advance their research programs. Our customers are able to make better decisions, and run research programs that are faster, more effective, and have less risk. As the regulatory environment evolves, that mission—and our end-to-end platform - becomes even more critical.”
About Instem
Instem is a leading supplier of SaaS platforms across Discovery, Study Management, Regulatory Submission and Clinical Trial Analytics. Instem applications are in use by customers worldwide, meeting the rapidly expanding needs of life science and healthcare organizations for data-driven decision making leading to safer, more effective products.
Founded in the United Kingdom in 1969, Instem has deep roots internationally across North America, EMEA and APAC. Instem maintain a commercial and technical presence throughout these regions and pride ourselves on localized support for our diverse client base. Learn more about Instem here: www.instem.com
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Contacts
Press Contact:
Mike Thurogood, VP Global Marketing: mike.thurogood@instem.com
