Powering the processes that lead to safer more effective drugs
The regulatory bodies’ preference for the electronic capture, storage and transfer of data for new drug submissions continues to grow, complementing the demand from pharmaceutical organizations and their collaborators to manage their compliance risk. Additionally, companies are increasingly keen to leverage vast volumes of historic data to help them to improve the suitability of drug candidates using.
Instem has the unique ability to provide comprehensive software solutions and services across the R&D continuum to meet the needs of life science and healthcare organizations for data-driven decision making
Key Industry Initiative Spotlight: The Standard for Exchange of Nonclinical data (SEND)
Instem collaborates with regulatory authorities and industry consortiums around the globe to further their missions of increasing product safety while more rapidly introducing breakthroughs to improve todays’ way of life.
The SEND standard was developed under the auspices of CDISC, a not-for-profit organization that establishes standards to support the acquisition, exchange, submission and archive of nonclinical and clinical research data and metadata. The introduction of SEND for both regulatory submission and the electronic exchange of toxicology data is having a significant impact on the industry...read more about SEND
Government Research Community
Instem’s government practice has been developed to consolidate and leverage our proven commercial experience, as agencies and their partners look towards technology to better investigate environmental risks as well as the causes, treatments, and cures for common and rare diseases and conditions.
Our government program clients benefit from the heightened focus of an Instem team that tailors best practices for software development, support and services for what can be specialized research program requirements around the world.
Some of our notable government clients include:
- National Center for Toxicological Research (NCTR)
- National Institutes of Health (NIH)
- United States Food and Drug Administration (US FDA)
- Health Protection Agency (HPA)
- United States Army Medical Research Institute of Infectious Disease (USAMRIID)
- National Institute of Environmental Health Sciences (NIEHS)
- National Institute of Allergy and Infectious Diseases (NIAID)
- Health Canada
Instem additionally supplies enhanced indirect government support to a wide number of research programs throughout its customer community such as those being managed by Battelle or the independent nonprofit SRI International.
Contact us for more information about our government practice at instem-gov@instem.com