As the need to improve patient safety in clinical studies and trials continue to rise, so will the implementation of technological solutions to ensure efficient data capture and clinical outcome assessments. Instead of using paper diaries, research sites can construct electronic patient reporting outcomes (ePRO) and schedule them for study participants. Using ePRO to monitor compliance facilitates instant AE/ASE results through COSMOS automated notification system.
Device Independent Data Collection
When participants use ePROs in clinical trials, they can respond to questions and provide reports throughout the clinical trial period. This can be done over a range of devices such as iPads, tablets, or smartphones designated for the study. It can also be done through an application installed on the participant’s personal device.
COSMOS ePRO offers automated notifications and reliable survey tools that facilitate the collection of accurate and complete data. This tool meets and exceeds all global regulations for collecting clinical trial data, including21 CFR ICH/GCP and HIPAA.
Generally, eCOA and ePRO offer an actual value to clinical trial data collection. These solutions open the door to collecting objective world evidence, a concept of growing focus in the industry as we look to evaluate product performance and improve safety and effectiveness for users.
Are you curious about how COSMOS ePRO would work for your study? We are happy to show you how you can get accurate data faster with electronic patient-reported outcomes collected from anywhere, on any device.
An effective eCOA solution helps keep study participants engaged during the entire clinical study or trial period. COSMOS is specially designed to seamlessly capture accurate outcome data manually or virtually while encouraging higher patient engagement.
Additionally, ongoing communication, various motivators at different time scales, and significant rewards at the completion of each treatment reinforce acceptable patient behavior and help keep them participating in the study.
The Benefits of Patient-Reported Outcomes
The patient-reported outcomes approach is becoming widely accepted as a crucial component by which the efficacy of outcomes is measured. However, the implementation changes still pose challenges during clinical study and trial set up and accurate data collection phases. COSMOS ePRO offers you the chance to streamline the electronic acquisition of patient-reported data through any device.
- Optimized study start-up timeline: The study start-up timeline is reduced to four weeks compared to the 16-week industry standard.
- Higher efficiency: Auto-generate project and regulatory documentation.
- Improved data quality & compliance: Ensure accurate data entry and timestamping, accurate scheduling, and get timely reminders.
- A comprehensive library of assessments: A vast library (pre-built) that facilitates rapid deployment.
- Device-independent: Secure data access from nearly any device, which means less expenditure and flexibility.
- Patient safety: Capture accurate AE/SAE data in real-time.
- Real-time insights: Access and review clinical study data in real-time for actionable insights and more informed decision-making.
The COSMOS ePRO handles all the complexities associated with patient-reported data collection and management. It offers the flexibility to switch between remote and in-clinic data collection as well as the ability to support validated survey instruments. COSMOS ePRO utilizes an independent model that allows study participants to respond to clinical surveys remotely and at any time.
Additionally, our platform’s automated alerts ensure compliance with site protocols while encouraging patient engagement. Indeed, the unification of COSMOS ePRO allows investigators and site research teams to view their clinical and patient-reported information in a single dashboard and improves study design timelines. With COSMOS ePRO, you can enjoy fast & actionable insights into patient-reported data, increased patient engagement, patient safety, and control over clinical study timelines.
Improved Patient Engagement
- Facilitate efficient data collection anywhere – at work, home, or in-clinic using the most convenient device for patients.
- Improve adherence with highly flexible schedules based on the patients’ closeout windows that support highly time-sensitive data collection, time zones, and alerts that integrate seamlessly with patients’ lifestyles.
- Quickly validate the assessments completed by each study participant.
A Unified ePRO System
- A simplified setup that eliminates the need for multiple vendors
- Improved patient safety and AE/SAE detection with real-time alerts, access to patient-reported data, and clinical data in a single dashboard.
- Enhance study participant compliance, data quality, and subject safety.
Streamline your Path to Efficient Decentralized Clinical Trials
COSMOS eCOA (Clinical Outcome Assessment) has revolutionized how CROs, sponsors, and research sites collect electronic data from caregivers, patients, and physicians. It is an independent platform that offers a flexible, intuitive model to capture patient data in a way that makes it easy for the patients to engage in clinical studies and trials. Created as an integral component of the unified COSMOS ecosystem, eCOA improves clinical study experience while providing flexible deployment options and dedicated support.
Fast Study Start Times
- Effectively accelerates clinical study start-time using a vast library of pre-built and pre-approved instruments.
- Offers a single-point data entry, few queries, and accurate data.
- No end-of-study integration or mapping is required.
Flexible and Easy to Use
- Encourages patient engagement
- Synchronizes seamlessly into your clinical dataset.
- Provides a dedicated patient cloud helpdesk that makes virtual trials a reality.
Unified Platform Approach
- COSMOS eCOA platform integrates with any EDC
- Facilitates data management that resonates with eCRF data management.