Improving Data Collection in Clinical Trials with TeleDiary™ for iPad, iPhone, Android Phone and Android Tablet
In the past paper diaries have been an acceptable form of data collection in clinical trials, though they have not proven to be the most reliable. One study dramatically showed that when a monitoring device was added to a paper diary without the patients’ knowledge, only 11% of the patients were compliant with the reporting process. It detected that patients were entering information retrospectively, and even writing in future entries.
When the patient is aware that they are being monitored by an IVR or IWR system, the compliance rises to 85 – 95% (data on file). The ease of accessibility to web and phone also enhances compliance. Clear definition of ranges of responses limits extemporaneous “in the margins” responses, making for a simple patient experience that results in efficient and high quality data collection for sponsors.
IVR Clinical Concepts Inc. introduces IWRS TeleDiary™ which now improves access and data entry not only by touch-tone telephone (IVRS), but also on most internet-connected smartphones and tablets (IWRS). Because we have integrated our phone data collection with our secure website access systems, our clients do not need any costly special device hardware. Sponsors save money when patients are able to access the study via their own phone or device.
With a variety of accessible interactive devices, TeleDiary™ integrates electronic Patient Reported Outcome (ePRO) collection across multiple centers in a clinical trial.
TeleDiary™ significantly improves the experience for patients, offering them flexibility, convenience and a user-friendly system for reporting in a way that is easy for them; by phone, computer, mobile device or tablet. TeleDiary™ also significantly improves the experience of the sponsor by increasing the accuracy and quality of patient reported data for clinical trials.
Improved User Experience
- Our validated TeleDiary™ IWR system uses a graphical user interface via most touch screen tablets and smartphones to greatly improve interactivity and accessibility in the study.
- TeleDiary™ is responsive and detects the user’s type of device and browser. The graphical interface automatically formats to the user’s screen for maximum usability.
- PRO data can be collected through a number of methods, including questionnaires, visual analog scales (VAS), response time, coordination tasks, high resolution image capture and evaluator interview with video conferencing.
- Questions encourage simple, easy responses. This reduces patient stress during ePRO collection.
- Security features include unique password and free hand signatures.
- Our software architecture allows patient data to be recorded in real-time through the device’s wireless connection directly to our secure database servers.
- The data are also stored centrally on our servers through our secure hosted websites.
- Soft and Hard locked data in any number of formats required by the client is available as soon as the last subject is completed.
Improved Data and Sponsor Experience
- Built-in compliance feedback facilitates communication between enrolled subjects and designated site/study personnel via automated push messages, SMS text messages, web reporting and emailed/faxed reports.
- Alerts can be released after meeting only certain pre-programmed conditions.
- Compliance enhancing initiatives including newsletters, lotteries, and varied compensation plans can be pushed to the subjects as needed.
- Branching in questionnaires, a standard since TeleDiary’s inception, allows for protocol-specific follow-up questions to be posed based on previous responses for PRO and adverse event data collection.
- IVR and IWR TeleDiary™ integrates with EDC and other electronic data systems to ensure continuous data delivery for sponsors and partners across all phases of clinical trial development.
TeleDiary™ improves the user experience for patients as well as the accuracy and quality of data for our clients.
TeleDiary™ also ensures compliance with FDA and EMA requirements for validated ePRO data collection tools and is fully CFR21 part 11 compliant. Studies have shown that enhanced compliance measures significantly improve the compliance and quality of data collected in clinical trials.