CONSHOHOCKEN, Pa.--(BUSINESS WIRE)--Instem, a leading provider of IT solutions to the global early development healthcare market, announced today that Lou Ann Kramer has joined its senior management team supporting CDISC’s Standard for Exchange of Nonclinical Data (SEND).
Prior to joining Instem, Lou Ann held several key roles for over 30 years at Eli Lilly including team leader responsible for all preclinical submissions globally. Over the past 8 years Lou Ann also oversaw preclinical information services, was Lilly’s point leader for all SEND efforts and acted as an industry liaison with the FDA/CDER/Computational Sciences Center on data standards initiatives.
In her role at Instem, Lou Ann will be helping organizations become SEND-enabled, guiding them from education through to the efficient management, exchange and submission of study data driven by Instem’s rich set of solutions and services.
“Lou Ann Kramer is well known in the community and her rich experience in regulatory submissions and compliance coupled with her practical understanding within the preclinical segment will have an immediate positive impact for our clients around the world,” comments Mike Harwood, Senior VP at Instem. “As the current team leader for standards development and as a member of the technical leadership committee for CDISC, we are honored she has chosen to join us as we help industry prepare for SEND and leverage the capabilities of our submit™ platform.”
“Having worked with SEND since its inception and having introduced the first complete software package to industry, Instem has become known as a world authority on SEND,” comments Lou Ann Kramer. “I’m very excited to be joining this experienced and well-regarded team of industry experts. Our common aspirations of ensuring organizations realize the benefits of SEND in health care and in their overall business effectiveness was a key element of my decision to join Instem.”
Lou Ann has received an FDA/CDER Honor Award, was recognized by CDISC for her leadership and received the LRL Six Sigma Green Belt Team of the Year award by Eli Lilly.
Following the issuance by FDA of the long awaited final Guidance for Standardized Study Data for providing regulatory submissions in electronic format in December of 2014, demand for Instem’s market-ready solutions has increased. Instem has licensed over 30 sites in 11 countries with its submit™ solution suite enabling clients to create and manage SEND study datasets throughout their lifecycle and is allowing sponsors, CRO’s and regulators to share, visualize and analyze study data more efficiently.
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.
To learn more about Instem solutions and its mission, please visit www.instem.com.
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