YOU NEED TRIAL DATA YOU TRUST. WE’RE HERE TO HELP.
Let’s face it, when you need trial data you can trust, there’s no other option than electronic clinical outcome assessments (eCOA). Studies have shown that paper assessments have historically low compliance rates with study protocols, and don’t often meet the founding ALCOA principles of good clinical trial documentation.
So, if you’re looking to collect data about your patients’ primary or secondary endpoints, side effects, quality of life, or other data – turn to TrialMax from Signant Health, and position your trial for success with eCOA ePRO data you can trust.
WHAT IS TRIALMAX?
TrialMax is Signant Health’s eCOA/ePRO platform that enables, simplifies, and streamlines COA data collection for patients, sites, and study teams. TrialMax succeeds at simplifying the COA process because it was built by clinicians, for clinicians, while leveraging our 20+ years’ experience of scientific, operational, and regulatory experience.
Looking to learn more? Check out our video on TrialMax here and see for yourself.
TrialMax Multiple Modalities
TRIALMAX eCOA SOLUTION
When it comes to eCOA – the patient experience matters. Studies show that even the best patients are prone to errors when forced to make time to record outcomes and diaries. TrialMax understands this, and make it as easy as possible for patients to provide timely, accurate and reliable PRO data from anywhere in the world. Watch the video and see how TrialMax ensures sponsors receive quality data they can trust.
TrialMax has been developed and continues to evolve based on best practice learnings from collaborating closely with sponsors, sites, partners, and patients on thousands of global clinical trials. When you choose our team to capture and manage eCOA data, you will benefit from this experience with…
Design & Equivalence
You need custom COAs designed around your study needs.TrialMax leverages our proprietary design tool, TrialStudio, to collaboratively build eCOAs for your study – and includes an industry-exclusive real-time emulator preview of your diary as it is designed. And, if needed, we’ll help you conduct equivalence testing to ensure comparability of data captured across different modes or devices.
Navigating scale management isn’t an easy task to accomplish alone. Signant Health supports you with scale licensing, validation, testing, and all translation processes to ensure your instruments are culturally and conceptually equivalent. As needed, we offer linguistic and psychometric validation services, ensuring your chosen instrument is fit for its purpose. We also maintain a comprehensive eCOA Library of scales (see below) to ensure the quality, validity, and speed of implementation on any device in your trial.
Global Logistics and Helpdesk
Building great software is only one part of a successful eCOA trial – global logistics and support requires experience, scale, and expert project management to make it work for patients and sites wherever your trial finds them. Signant Health has unsurpassed experience with managing eCOA trials in over 60 countries. We manage device inventory and shipment globally, while providing 24/7 help desk support for your patients and sites in over 150 languages. Helpdesk representatives are fully trained on each of our solutions and backed by managers with over 20 years of experience, and resolve over 90% of support calls on the first response.
Reporting, Analytics and Audit Trail
Your ability to steer your trial depends on your ability to understand how it’s progressing. TrialMax’s reporting interface provides exportable data and intuitive, color-coded dashboards to help you make decisions based on reliable study metrics. In addition, our industry-leading audit trail allows authorized personnel to access and explore real-time user actions and inputs through interactive reports and dashboards in just a few clicks though our enterprise analytics platform.
Technology only achieves its full potential when supported by a strong collaboration with your experienced project management team. Our Accel Initiative is a commitment to continual improvement in deployment timelines and service quality excellence. From design meeting best practices and our eCOA library to test automation, localization tools, and rigorous quality oversight, Accel ensures we will get your patients up and running on TrialMax as quickly and reliably as possible.
A proven science team with over 20+ years’ experience
Our cornerstone as a company, Signant Health’s science team is paramount in both developing our solutions, while providing operational guidance to our teams and their clients. If you have questions, concerns, or simply want to walk through the best eCOA strategy for your trial – outreach to us today for a consultation with our clinicians!
Any reliable and well-designed eCOA platform will provide countless benefits over paper diaries, especially when it comes to trustworthy data and compliance rates. But simply being better than paper isn’t enough. As part of the industry’s most comprehensive patient platform, TrialMax provides added value that only Signant Health can offer including…
Sensors and Wearables Integration
Simplifying the patient experience and providing modern consumer-quality tools is key to improving data quality. Integrating sensors and wearables (e.g. activity and sleep trackers, continuous blood glucose monitors, respiratory function monitors) into TrialMax makes it easy to capture and manage reliable objective measurements in addition to patient- and clinician-related outcomes. This ensures that your populations’ needs are addressed and accounted for, while ensuring you get the data your trials deserve.
A Comprehensive eCOA Library
Signant Health manages a robust eCOA scale and instrumentation library of validated scales for use on the TrialMax platform – featuring a dedicated team that manages the process from design through build, test, and release. Our ever-growing library improves quality, reduces deployment time and costs, and streamlines localization, leading to additional downstream benefits including reduced deviations, queries, and time to data lock.
eConsent and Patient Engagement on the Same Device
eCOA can transform data quality by itself, but it’s even better when paired with eConsent and Patient Engagement on the same device– providing a single platform for patients, sites, and study teams that’s friendly, intuitive, and designed to keep everyone in the trial informed, active, and on-track.
Blinded Data Analytics (BDA)
Being able to trust your data, including subjective patient-reported and rater assessments, will enable you to make informed decisions faster. That’s why we use multiple layers of study blinded data to identify patterns, trends, areas of improvement, potential waste, fraud, and more. This enables our customers to understand where their trial is headed, enabling them to course correct if necessary, or catch a small issue before it becomes a large problem. Led by experienced data experts and clinicians, our blinded data analytics solution ensures the reliability of your incoming trial data and reduces noise so you are better prepared and able to detect a potential signal.
WE’RE READY TO HELP WITH eCOA ePRO
Learn how we can help improve your global clinical trials with a demo or speaking with one of our experts.