Evidence & Performance Blog

LSIT (Life Sciences Information Technology)is a non-profit organization bringing together several industries to build the first Good Informatics Practices (GIP) guidance document to assist IT in 5 areas: compliance, standards, best practices, risk mitigation and return of investment. GIP is the guidance for improving quality and trust of IT within life sciences and healthcare.

GIP guidance document compiles standards in one reference guide for an IT system of a life science or healthcare environment.

All functions within a life science organization require significant use of multiple IT platforms. Their intellectual property, knowledge management and data are on IT systems that must be trusted and secure.

The integration of IT into Life Science and Healthcare has a “real potential for reducing both the time and cost of bringing new medical products from discovery to the patient. The one main inhibiting factor is “trust”. Trusting that these very complexes IT tools, computational processes, and resulting data are, in fact, accurate and scientifically valid, is critical for all stakeholders and gatekeepers alike”.

More information is available on http://www.lsit.org/

US-Based Phase Forward, specialized in data management solutions for clinical trials and drug safety pays US$40 millions for Clarix LLC, a provider of fully Web-integrated interactive response technology (IRT). Read more

I’m coming back on initiatives around Performance Metrics in the Clinical research area. Someone forwarded me this interesting link: http://www.eclinicalforum.com/

You can find a very good and complete survey of companies involved in conducting EDC trials to assess the feasibility of establishing standard metrics for the assessment of EDC performance. It is not a new document (June 2004) but it gives very useful and focused approach to benchmarking EDC performance.

Lorena Levi, Trainer at Fundacion Cecilia Grierson in Argentina, is sharing with us her experience in operational and performance management in South / Latin America.

Lorena and myself talked about this in the past week, and I am now sharing her thoughts with you. Read more