Electronic Patient Reported Outcome (ePRO) Software

Octalsoft / eClinical Solutions / Electronic Patient Reported Outcome (ePRO) Software

In the paper world, many of us have come across incomplete and illegible patient diaries. Transcription of these paper diaries into the data management systems has its own set of inherent risks and complicating factors. The utilization of electronic patient reported outcome (ePRO) data in clinical research has gained popularity in recent times of COVID-19 and moreover after the regulatory authorities have acknowledged the credibility of such data, particularly in comparison to paper and pen diaries completed by the patient in unsupervised settings. Octalsoft ePRO software is designed to streamline the collection of meaningful patient reported outcome data, that supports early to late-stage clinical development phases and post-approval trials. It helps clinical trial sponsors to leverage technologies for collecting drug compliance, symptoms, medical events, and quality of life (QOL) data in a credible and electronically supervised fashion. Octalsoft ePRO solutions simplify and streamline the entire data collection and management process, and thus not only help your trial stay on track but also reduces costs and saves you time. Octalsoft ePRO provides a digital alternative to patient diaries and is designed intuitively keeping the user interface in mind. It is the right ePRO solution that works for both, your study and your patients alike.

Why choose Octalsoft ePRO?

Patient-centric design with enhanced User Experience (UX)
Improved patient compliance and engagement rates as compared to physical PRO diaries
Higher PRO item completion rates
Validated time stamps for completion of contextual information
Prevents data errors due to recall bias
Faster access to patient’s PRO data and real-time monitoring for significant changes in their health status or symptom thresholds.
Automated alerts to trial participants and researchers
Compliant with ISPOR ePRO Systems Validation
Easy integration with EDC, IWRS, eCONSENT, and CTMS technologies
24×7 vendor support and training

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Product Features

Configurable ePRO Designer

Octalsoft is experienced in working with standard validated questionnaires for PRO data collection, QOL, Drug Compliance, and Symptom Assessment. Octalsoft ePROs form builder comes with an intuitive drag-and-drop interface that makes it easy to configure standard fields such as single/multi-choice or Yes/No questions, Visual Analog Scales (VAS), Numeric Rating Scales (NRS), Likert Scale, photo/video uploading, and many other outcome data measures. The sponsor can opt to create new fit-to-purpose questionnaires and surveys or choose from the broad range of our validated disease-specific PRO library.

User-Friendly Interface

A confusing patient user interface can dilute the efficiencies of an ePRO system. Octalsoft ePRO software is designed to provide the most effective, user-friendly surveys with easy navigation, for naive patients to get the hang of it quickly. Simple page layouts, chronological response mechanisms, conspicuous progress bars, and unambiguous error messages all lead to an enhanced patient experience thereby increasing compliance to diary completion.

Patient Engagement Features

Octalsoft ePRO comes with the capability to set up response-driven push notifications or emails to remind patients to report their outcomes at the right time. Additional tools for patient engagement such as welcome and thank you notes, newsletters, interim training, etc can be integrated as per the trial protocol requirement and can be timed to be delivered when it matters and when it’s relevant for the patient. Our patient engagement hub is designed to be rich in content and graphics and targeted to drive the key behaviors that patients need to maintain in order to keep up with their diary completion requirements.

Compatibility

Octalsoft ePRO is compatible to be used on mobile applications, tablets, and on the web interface. It is accessible via downloadable mobile apps for android, windows, or iOS. The software can be provisioned on the client provided device or patient’s own smartphone, also referred to as “Bring Your Own Device – BYOD”. Irrespective of the different administrative modalities used for deployment, Octasoft ePRO provides easy to read display screens and unambiguous areas for touch-screen or stylus responses.

Easy Integration

Octalsoft ePRO is a part of our unified eClinical Suite and can be easily integrated with our existing Interactive Web Response System (IWRS), Electronic Data Capture System (EDC), Electronic Consent Software (eConsent), and any other third-partytools that your trial could be using.

Secure and encrypted

Octalsoft ePRO ensures that patient reported data is secure and the privacy and confidentiality of the patient is protected, at all times. All ePRO data is encrypted and compliant with all FDA and EMEA regulatory requirements including 21 CFR Part 11.

Product Benefits

Quicker and Real-time Access to Data

Octalsoft ePRO facilitates the direct capture of electronic patient reported outcome data. This data is immediately checked for consistency and completeness and is made available to the site personnel and Investigator, who is responsible for monitoring patient safety and compliance. Side effects and unexpected problems that deserve immediate review and action by investigators are available in a timely fashion.

Improved Data Accuracy

Octalsoft ePRO is programmed to generate alerts when data entered is either invalid, illogical, or exceeds the acceptable threshold. Real-Time alerts notify clinical staff and prompt patients to immediately re-enter data; thus, data discrepancies are resolved remotely and instantly. Another key advantage is the ability to program the questionnaire to appear at pre-set times for reporting parameters and avoid the recognized limitation of paper-based PROs’ “parking lot effect”. The patients cannot back-fill or pre-fill data, and each data point is date and time-stamped with the patient’s local time, documenting exactly when the entry was made.

Rapid Resolution and Reporting

The ability to receive and analyze patient reported data in real-time allows the trial Investigator to quickly react to adverse events and serious adverse events, thus leading to greater safety measures for the trial participants. Apart from safety episodes, the site personnel can get notified about events of interest such as – whenever a patient misses drug dosage or if the patient achieves a critical end-point in an outcome-driven clinical trial.

Reduce Transcription Errors

Paper diaries are cumbersome to complete and can lead to data integrity issues. Octalsoft ePRO allows trial patients to input outcomes directly into the trial database eliminating data duplication, transcription errors, incorrect interpretation of hand written responses, and the need for source data verification.

Enhanced Patient-centricity and Compliance

With Octalsoft ePRO, patients now have a significantly improved and flexible user experience. ePRO provides a secure method for subjects to enter diary information in the comfort of their homes and in the way that best suits their needs. An ePRO system helps to keep the patients more engaged and fulfill their responsibilities more easily, and this increases the likelihood of their compliance with information gathering requirements.

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