Clinical Trial Protocol Compliance

mHealth to Manage Compliance and Effectiveness

By Wessam Sonbol On Dec 7, 2016

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The number of clinical trials is on the rise year over year. With growth, there is always the need to identify better ways to handle compliance and better secure processes. With such growth, we see a growth in compliance issues across multiple factors, including protocol design, patients following their medication intake regimen and continous remote monitoring.

With rapid growth of mobile phones, it only makes sense to utilize such technologies to reduce protocol risks and ensure compliance across multiple verticals

How can mobile phones help?

While a lot of companies are focusing on utilizing mobile phones to manage patient treatments, we see that there are other uses that have been ignored. For example, ensuring that everyone has the most up to date protocol information is very important. How often has someone used previous protocol revisions, causing data entry issues or protocol deviation?

What about a simple application that can capture the following:

Investigator & Site Recruitment
  • Study Design
  • Inclusion/Exclusion
  • Treatment of Subjects
  • Study Visits
  • Forms to be completed for each visit
  • Assessment of Safety
  • Adverse Events
  • Study Contact(s)

Easy Access

Providing your investigators and study team easy access to data goes a long way. The life science industry is now experiencing more data than they ever have. As Investigators get involved in multiple studies, and the study teams manage multiple studies, having easy access to the latest study details can go a long way.

What if you are sitting with a patient and you want to be able to give them a schedule right away? Wouldn't it be simple to use your phone, enter in the data and in less than 10 seconds you have the answer?

Investigator & Site Recruitment

Collaboration

It is essential to ensure proper collaboration among the research team, investigators and laboratories to ensure proper procedures are being followed for patient safety from enrollment through completion.

Communicating through a mobile app will ensure that everyone has the latest study guidelines and processes to follow. In addition, users can collaborate through the app rather than having to send emails back and forth.

Think of how many times you sent someone an email that you could not track. You don't know for sure whether that user received the message or not. By using a mobile app, it is easy to send a message to the entire team or just one person. You can also track whether that person read the message or not because it is all tracked within the application.

Central Study Location

One of the most common issues the life science industry deals with, is the data silos. Study documents saved someone on the cloud, guidelines are printed on paper, videos are on email, training material are somewhere different and study reports are somewhere else.

The process of searching across the different silos is an effort that costs a lot money, causing wasted effort. It is estimated that each of these different processes can take up to 30 minutes. Having a central repository to track all study related material has proven to save time and money.

Protocol Amendments

In over 17 years, I have yet to see a protocol that was not revised. One of the issues we see with protocol amendments is the site oversight of the changes that occurred and proper communication. Can today's mobile technologies mitigate such issues?

Our cell phones can help us be more efficient and ensure compliance

  • Accessibility. Rather than having to read through papers and browse through emails, have it available at your finger tips, anywhere.
  • Boost product branding.
  • Study tips and training material available on the go.
  • Consistency. Ensure everyone has the latest protocol information.
  • Improved communication. Send alerts and updates to the study teamĀ and track receipts.

StudyPal is a cloud based mobile app, allowing users to easily configure all protocol content online and have it easily accessible through the app. Learm more here.

Interested to learn more about StudyPal? Request a free trial below or by emailing info@delvehealth.com

Our aim is to accelerate drug development and save more lives.

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