The following is an excerpt from our ebook “Clinical Trials in the Digital Age: Leaner, Smarter and More Connected”. Click here to download the ebook in its entirety.
Pharma may be laggards compared with other industries in harnessing technological advances, such as digital platforms and artiﬁcial intelligence, to execute the business philosophy of lean, but this scene is unquestionably changing.
‘Deﬁnition’ of Lean: “[Organization] of human activities to deliver more beneﬁts to society and value to individuals while eliminating waste”
As noted recently by Novartis’ CEO
And it’s not just money saved: Amgen, for example, aims to shave 6 months off the duration of clinical programs through the design of leaner trials. As a sponsor, imagine the potential gains you would have over a competitor if you could bring your product to market substantially earlier. And for patients, how great would it be to be able to offer treatments in a timelier manner?
The Era of ‘e-‘ in Facilitating Lean
The traditional way of conducting trials is clearly going the way of the VCR, ﬂoppy disk
Championed by regulatory agencies and aligning more with the patient-centric direction of clinical research, electronic data capture (EDC), electronic trial master ﬁles (eTMF), electronic health records (EHR), electronic patient-reported outcomes (ePRO), electronic clinical outcome assessments (eCOA), electronic signatures, and electronic informed consent are just some of the e-based approaches currently used to reduce paper-based errors, be regulatory-ready, and free up site staff to perform more value-added tasks. In parallel, patient recruitment, retention, and compliance are enhanced, as joining and supplying information to a trial become
Together with clinical trial management systems (CTMS), randomization and trial supply management (RTSM; i.e. interactive response technologies (
The value of automating processes such as on-
This blog post is an excerpt from our ebook “Clinical Trials in the Digital Age: Leaner, Smarter and More Connected”. Click here to download the ebook in its entirety.