When it comes to simplifying clinical trials, the most important change companies can make is to embrace the 21st century and its digital benefits, including how they approach risk management. It’s no secret that the pharma industry’s commitment to paper-based communication and documentation is nothing short of archaic. Recognising this, Section 2 of the ICH GCP E6 Addendum reflects on the modernisation from paper-based trial documentation to electronic systems and while security can be an issue, the benefits and controls of digital communication are proven in the systematic, prioritised, risk-based approach to monitoring clinical trials.

Pharmaceutical digital solutions company, Teckro, provides answers to the questions that clinical trial investigators and research site staff have via the digitisation of study documentation and the streamlining of communication (between sponsors and research site staff).

Cayce Drobek, Senior Director, Clinical and Solution Consulting at Teckro, told Pharmaceutical Technology, “Our platform removes the need for paper protocols and paper-versions of other study documents by digitising content and making it instantly searchable from anywhere at any time (24/7 access).”

Digital transformation for the present

While the uptake for digital transformation has been incredibly slow in the pharma industry when compared with other heavily regulated industries, such as banking, the new addendum seems almost designed to hasten the digital transformation. It discusses centralised monitoring and shows the benefits of real-time reviews of accumulating trial data – that it helps to identify missing or inconsistent data and errors, examine trends, analyse sites/investigators, and help select sites for targeted on-site monitoring.

“The Teckro platform contributes to a risk-based approach by giving Sponsor study teams real-time insight into monitoring, management and reporting/communicating key data points as identified in the addendum,” explains Drobek. “And what that really does, in simple terms, is to give the teams time savings, so they don’t have to work across multiple systems; increased efficiency because it streamlines communication – I mean, previously, you’d have the same conversations over and over via text, various portals, phone, paper communication methods and so on.”

Teckro not only offers its platform and comms solutions, it also owns and operates its own search engine for clinical site staff and monitors. The instant access to protocol and other trial documentation helps to increase efficiency and speed to market – something that’s become ever more important in the COVID-19 era.

This pandemic, more than anything else to hit the industry before or since, has shown the need for a digital approach to clinical trials – and that includes risk and quality control. A digital approach, as with most situations, removes the potential for human error and allows for consistent quality and duplication of low-risk outcomes. Staff and patients can also communicate quickly, identifying issues up front and also allows for increased visibility of site user behaviour, engagement, and retention rates.

Connected, time-efficient risk management

The benefits that impress clients the most from using Teckro’s digital platform, says Drobek, are that “it helps prevent the general disconnect between sites, sponsors and monitors” and “helps to tackle inefficiencies in distributing and maintaining study document version control for each site –  and it’s a lack of this that contributes to protocol deviations and violations,” she says.

Regarding risk and the technological solution to preventing it, Drobek is practical: “The risks in the pharma industry are fairly similar to what they were 20 years ago. It’s just now we’re finally asking better questions about risk management, and asking if maybe, just maybe, just like in every other aspect of life, technology might be one of the answers.”

“For example,” she continues, “the timely safety management of patients in clinical trials. Safety events used to be reported via a paper report form that site staff had to fax or email. Sponsors thus were not aware of what was going on at the site or that a patient may be experiencing a serious safety event until after the fact.

But with Teckro, the risk is reduced because Sponsors now have more visibility into activity at the site, and sites are now more engaged because they have instant access to the information they need. Ditto with communication: they can interact with the sponsor directly versus having to go through multiple channels. They actually have a direct line of communication with the medical monitor, if needed.”

Mobile app for efficiency

“85% of Teckro users choose to use our app via their mobile devices,” says Drobek, “which offers access to 24/7, secure information and ability to communicate whenever they need it. That means if an Investigator gets a trial-related query at 7:00pm on a Friday night, it doesn’t matter if his/her laptop which houses a PDF version of the protocol is still at the site, they can just use the mobile app, which can help avoid costly time delays.”

Another great thing about Teckro is that the solutions are all configurable – sites and sponsors can bring their own internal processes into the technology, the communication pathways can be configured to the site’s specific needs – and it’s this kind of technology that is the true game-changer the industry needs when it comes to risk management