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 Dr Vas Narasimhan, “analysts have estimated that between 10% and 25% could be cut from the cost of trials if digital technology were used to carry them out more efficiently”.

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 and Walkman, and one of the biggest concepts that tech and cloud storage have enabled is the  paperless or e-clinical trial.

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 more convenient and intuitive.

Together with clinical trial management systems (CTMS), randomization and trial supply management (RTSM; i.e. interactive response technologies (IRTs) specifically, interactive web response (IWR)) to enable seamless end-to-end trial supply, clinical development is now more streamlined, transparent, and agile.

Take-Home Point

The value of automating processes such as on-demand site training, tracking inventory, patient education and consenting, among others, to achieve leaner processes is indisputable.

Now, as technology matures, clinical development is evolving to the next level. Massive amounts of data captured over the past 20 years, together with the latest digital advancements, are now being applied in highly innovative ways to develop smarter trials.