Outsourcing
Streamlining clinical trials across the board
Life-saving medicines and treatments depend on clinical trials in order to make it to market. The more streamlined the trials, the more medicine can be produced. With the potential to simplify trial proceedings for everyone involved – including sites and patients – ProofPilot’s new platform allows for a more comprehensive trial process.
linical trials are a risky endeavour, with a failed trial losing not only the investment into the trial itself but also the pre-clinical development costs, as well as future revenue potential. The rewards however, in the form of life-saving treatments for patients and revenue potential, are very high.
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Clinical trials are also, inevitably, highly complex, with studies planned and designed over many months by multidisciplinary teams of scientists and research experts. Considering how much rides on the success of clinical trials, it is surprising that sites – not to mention patients – are given so little support in the way of tools to help them carry out the most crucial part of the clinical trial process – study conduct. A clinical trial protocol may be an essential, regulated document and therefore a requirement for all sponsors. However, using the protocol document as the only driver to inform study execution and activities is a recipe for uncertainty, inefficiencies and ultimately a greater risk of errors.
will stop enrolling and conducting trials that are too hard to conduct.
Have a little patience Participating in clinical trials is also demanding for patients. Remembering their schedule of visits, what activities they are expected to perform and when, adds to the stress of already having to deal with difficult health conditions. The more simple and smooth that trial participation can be made, the more incentivised patients are to be involved in clinical trials, which is critical considering up to 85% of clinical trials fail to recruit enough patients.
Adding to the challenges already faced by sites, a study this year found that over 80% of research institutions report experiencing staff shortages. With trials growing increasingly complex as more precision medicines, requiring more endpoints to be recorded, are developed and ever more data is captured from patients, it is more important than ever that everything that can be done is done to simplify and streamline clinical trial conduct for sites and patients.
“With separate ‘Co-Pilot’ packages tailored specifically for sites and patients, ProofPilot’s platform streamlines, simplifies and optimises clinical trial conduct.”
For sites, having to decipher complex and unclear instructions from written protocols takes up a huge amount of time and effort, with staff repeatedly having to check what they are supposed to be doing, at what time, and with what technology. This impacts the level of care and attention personnel can dedicate to patients, who also suffer in turn from longer, drawn out site visits. In fact, sites
Clinical Trials Insight /
www.worldpharmaceuticals.net
With this in mind, ProofPilot has developed the industry’s first Digital Protocol Automation platform. With separate ‘Co-Pilot’ packages tailored specifically for sites and patients, ProofPilot’s platform streamlines, simplifies and optimises clinical trial conduct for all stakeholders, providing high performance clinical trial experiences for sites and patients and fewer errors, deviations and therefore higher quality data
for sponsors. Instead of sites having to use multiple, complex procedure manuals, Co-Pilot for Sites provides simple, singular, and digitised workflows, which integrate clinical procedures, technology and data collection. Every procedure within the protocol is broken down into component tasks and behaviors, with instructional reminders and links to the required technologies served up exactly when needed. Logistics requests are also automatically triggered at the appropriate times to ensure sites always have what they need, when they need it.
Co-Pilot for Patients supports patients’ progress through trials with clear instructions, reminders, and links to digital diaries and other technology. On top of this, content and information are timed and delivered in a personalised and culturally competent way, based on patients’ demographics and preferences. Such a tailored approach improves diversity in clinical trial populations, adherence to protocols and patient retention. As trials become more complex, sites find themselves understaffed, and recruiting patients for trials continues to be a challenge, it is in the interests of all stakeholders to simplify and streamline clinical trial conduct. ProofPilot’s digital protocol automation platform removes burden from sites and patients, using intelligent automation to take the guesswork out of clinical trials, improving adherence, reducing dropout rates and minimising protocol deviations. The result is a win for all involved, with simplified trial conduct for sites, an improved trial experience and higher quality data for sponsors, no matter the research setting. ●
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