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FDA Issues Draft Guidance, Moves Closer to making SEND a Requirement


FDA has issued the long-awaited draft guidance for providing regulatory submissions in electronic format. For those of you following SEND, please review via the link below and contact Instem to help you understand how to best leverage the standard in preclinical.

Guidance for Industry - Providing Regulatory Submissions in Electronic Format

About Instem

Instem is a leading supplier of IT applications to the early development healthcare market, delivering compelling solutions for data collection, management and analysis across the R&D continuum. 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.

Instem’s portfolio of software solutions increases client productivity by automating study-related processes while offering the unique ability to generate new knowledge through the extraction and harmonization of actionable scientific information.

Instem supports over 400 clients through full service offices in the United States, United Kingdom and China with additional locations in India and a full service distributor based in Japan.

Meeting clients at the intersection of investment & return™.

Press Contacts:

Gary Mitchell (US HQ)
Tel: 610-941-0990

Julie Jones (UK HQ)
Tel: +44 (0) 1785 825600