Platform and Adaptive Trials
Platform and Adaptive trials require novel technical design and management. Our software supports both Adaptive Randomisation and Platform Domains, in combination or on their own.
We collaborate with statisticians and trialists to ensure a holistic design and delivery of your randomisation needs, and ensure seamless adaptations to randomisation throughout the life of the project. From design, start-up, and beyond, we are your reliable technical partner.
We have been working with leading Australian and international experts for platform and adaptive trials since 2019. We bring this experience to your project as technical and data leaders, guiding the design and development phase, and ensuring you continue to benefit from improvements and innovation.
There can be great variation in the workflows of platform trials and using our incredibly flexible software we can optimise workflows to fit the most appropriate and efficient path for randomisation and data capture. Allowing state-based treatment reveal, multiple randomisations per patient, and multi-layered domain or treatment exclusion.
Electronic Data Capture
Electronic data capture is an essential feature of any modern trial, complementing or at times replacing paper CRFs. Improve data quality and accelerate database lock with web-based data capture that is visually pleasing and efficient.
Extensive data validation ensures accurate data entry and a powerful data query management function tracks all data issues to be reviewed.
Staff can login from anywhere in the world and securely enter their study data into the eCRF.
The audit log tracks item level changes to see who and when and what data was changed. Central or on-site monitoring is made easier with 'monitor mode' to allow ad hoc queries against any data item for sites to resolve.
Streamline Endpoint Adjudication
Our Endpoint Adjudication module provides a comprehensive solution for efficient and accurate endpoint determination in clinical trials. Endpoint logic and adjudication workflows are completely customisable to fit the needs of the trial and the team.
Our software offers custom automated workflows that simplify the process of endpoint adjudication, saving you time and effort.
The Endpoints module is integrated with the CRF module to automatically generate endpoints from entered data. Generate Endpoints using endpoint specific logic handling any level complexity.
Reduce time to endpoint finalisation by coordinating multiple stakeholders online in the adjudication process through customisable notifications. Let people know what and when something is required of them.
Engaging participants directly in your trial
Discover our platform to empower sites to manage their confidential patient contact data, while ensuring the patient survey results (ePROMS, patient diaries) are captured and stored in the eCRF.
Participants can opt in to SMS and/or email follow up for Daily Diaries, surveys, and validated patient-reported outcome measures (PROMs).
The PRMS solution is a standalone software solution, or can integrate seamlessly with the CTMS to generate surveys to be sent off, then stores the results with the eCRF.
Collecting participant responses on their own device, by phone, or handing off a device to participants? We’ve got you covered with our multi-workflow functionality.
Streamline Your Payments
Managing payments can be a complex and time-consuming task. With our Payments module, we take the hassle out of tracking which sites need to be paid and for what.
Our Payments module offers real-time tracking of what items are ready to be paid to sites. Automated payment triggers generate payable items based on custom logic for any number of different payable items. Manual payable items can also be generated at any time.
Produce clear and detailed payment request statements in a PDF to provide to sites for them to invoice you through their payment systems.
Integrate payments with randomisation, endpoints, CRF milestones, or any other part of the platform to automatically generate payable items from regular trial activities.
Drug Tracking and Stock Management
Manage blinded trial drug distribution, site stock, and dispensing with ease and efficiency. Our Drug module simplifies the process of tracking the movement of drug through its lifecycle. Track each individual vial or kit and where know where it is and where it's been.
Let our software manage the dispensing of blinded drug for you. For a given patient, the system selects the next available drug for their correct treatment allocation from the available drug stock in designated dispensing locations. Rest assured the system never dispenses expired stock!
Alert sites, central trial team, or the distributor when a total site is low on stock. The system allows for multiple locations to be defined at a site (e.g. pharmacy, theatre, research office), allowing for granular stock alerts to prompt movement of stock between locations.
All drug stock is monitored for expiration. As expiry dates approach, the site and central trial team are notified repeatedly until it is marked as disposed or otherwise dispatched to an appropriate point of disposal.
Randomise with Confidence
From pre-generated stratified block schedules, minimisation, through to adaptive and platform trials, our Randomisation module can handle it. Allowing inline inclusion and exclusion criteria, custom calculations, or any other data capture are possible to maximise the best fit for your trial's needs.
The randomisation module integrates seamlessly with drug, payments, CRF and all CTMS product features, as well as with the PRMS to trigger participant surveys at enrolment.
Increasingly a multi stage consent, eligibility and randomisation workflow is requested, for registries and platform trials. Our module can integrate to form a seamless workflow as you onboard participants across multiple visits and users.
Probability-based response adaptive randomisation (RAR) and multi-domain platform trials capabilities are available. See Platform and Adaptive Trials
Transforming Ideas into Reality
Introducing our Product Design and Development Service, where we combine creativity and expertise to bring your ideas to life. We bring decades of expertise in public health, clinical research, and excellent software and design capability to your project.
Good design starts with a deep interest and awareness of user needs and the problem and opportunity being addressed. We pride ourselves on our user-centric approach and tasteful aesthetic which drives good outcomes for users.
Our in-house Australian-based design and development team will work closely with your team to turn your idea into a functional web or mobile application product.
We can offer ongoing hosting, support and maintenance of the product if required, or deliver the product ready for you to manage.