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What is an eClinical program?
Many companies start up “eClinical” projects. But what is eClinical – and how does it support the R&D strategy?
Many companies start up "eClinical" projects. But what is eClinical - and how does it support the R&D strategy? According to industry thought-leaders, defining it as EDC or ePRO misses the point. The break-through benefits lie in taking a holistic approach to the "R&D IT System": re-engineering R&D through coordinated development of the systems portfolio.
An eClinical program is a coordinated portfolio of projects, each with the purpose of optimising R&D processes, supported by IT systems such as: Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), Clinical Data Management System (CDMS), Clinical Data Warehouse (CDW), Safety System, Product Supply, Interactive Voice Response System (IVRS), and Resource and Portfolio Management System.
These systems are typical components in a big pharmaceutical company's R&D systems landscape. By looking at this portfolio of systems they can all be considered components of a larger system, the "R&D IT System", supporting different parts of the processes being used in R&D.
In order to maximise the benefits that can be had by the amount of money the organization can afford to spend on IT, an overview of all these systems has to be established and their development coordinated. This gives the basis for assessing what specific benefits each component can give, and thereby the allocation of project funds.
On 7 February 2006, at NNIT's eClinical Conference in Copenhagen, this topic will be explored further by thought-leaders from AstraZeneca, Novo Nordisk, Bristol-Myers Squibb, Bayer, Serono, H. Lundbeck, Solvay and Merck & Co. Mail apb@nnit.com to take part.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
The Transformative Role of Medical Information in Customer Engagement
October 3rd 2024Stacey Fung, Head of Global Medical Information at Gilead Lifesciences, delves into the evolving role of Medical Information (MI) in the pharmaceutical industry. Covering key topics like patient engagement through omnichannel strategies, combating misinformation, and leveraging AI to enhance medical inquiries, the conversation with Stacey highlights MI's critical role in ensuring patient safety and supporting drug development. She also shares her professional journey and tidbits for early career professionals on professional development.
To Tackle the Plastic Waste Crisis in Pharma, Here’s Where to Start
October 30th 2024By demonstrating big advancements in recycling, pharma companies will be much more likely to attract shareholders and other investors, giving themselves a leg up in the competition to lead the biopharmaceutical industry well into the future.
