Sponsors agree the coronavirus pandemic exposed shortcomings of existing processes in clinical trials

Written by David Connelly

Modern technologies support agile processes for clinical trials

95% of attendees to our webinar this week agreed with the central message that processes and supporting technologies commonly used in clinical trials are outdated, and furthermore they contributed to the huge disruption of clinical trials caused by the COVID-19 pandemic.

Systems and methods for data collection, monitoring, review and analysis have evolved in a piecemeal fashion, and whether well suited or not, are normally “bolted together”. Not surprisingly they provide inflexible, high cost solutions, riddled with limitations and workarounds that struggle to meet the needs of sponsors and modern clinical trials. Most clinical trial data isn’t even captured or managed in Electronic Data Capture systems. COVID-19 has shone a spotlight on them and ruthlessly revealed their flaws.

Data systems are not peripheral. Put simply, the core output of a clinical trial is data, used to derive critical information for decisions on efficacy and safety. Data quality and integrity are critical. And many ongoing clinical trials will now face data challenges because of the disruption caused by COVID-19.

The industry needs a new approach that puts clinical data at the core and applies the capabilities of modern, flexible technologies to combine different types of trial data in a changing world for rapid and thorough analysis. Not only will this approach streamline current processes, but technologies like encapsia can also support new processes, as encapsia is a very agile system able to respond to a rapidly changing environment. For example it can seamlessly mix data capture via web EDC, direct data capture eSource and a mobile home visit app that even works without a steady internet connection.

In another example of system flexibility, encapsia was rapidly enabled in response to COVID-19 so that sites could easily provide source data for remote review, using a new app for smartphones with strict privacy controls.

Click here to see a recording of our webinar, “COVID-19: The catalyst for long overdue change in clinical trial technologies and processes”

For a no obligation discussion with one of our clinical trial experts about processes that put clinical data at the core of clinical trials please contact:

Jay Conze in US
jconze@cmedresearch.com (919) 595 - 1115
or Maria Iliescu in Europe
miliescu@cmedresearch.com +40 732 440 322