Complete ecoa Solutions

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1 Complete ecoa Solutions One Solution for all Your Protocol Requirements KEY BENEFITS Improves Protocol Execution Flag missing or incorrect data, provide automatic calculations, and include instructions or videos to reduce errors during the actual patient visit. Simplifies Complex Studies Supports enhanced electronic scales to help clinicians better navigate through complex protocols. Clinical Ink s SureSource technology offers one platform for managing and capturing data for all your study protocol requirements such as screening, enrollment, randomization, vital signs, physical exams, adverse events, and questionnaires. We support a large assortment of clinical outcomes assessments covering ClinROs, ObsROs, PerfOs, and PROs for a wide range of phases and therapeutics areas from Oncology to CNS studies. SureSource eliminates the need to have paper source, EDC, and ecoaonly tablet solutions. With SureSource, you have one solution to centrally access clean comprehensive clinical data, as esource, immediately after the patient visit. By making clinical data collection easier for clinicians and patients, SureSource improves clinical trial efficiency, quality and safety. SureSource eliminates time-delays to access and review data and eliminates data errors that cause unnecessary queries often seen with other data capture methods. Centralizes Monitoring All source and study data are captured simultaneously, electronically, providing you an immediate comprehensive view of study data. Increases Compliance Mobile reminders and studyrelated information improve clinical trial patients compliance with medication and protocols. Improve Retention Reduce patient burden and improve communication to keep clinical trial patients engaged and enrolled in studies.

2 Reported Outcomes at Clinical Sites Specifically designed to address the workflow needs of research sites, SureSource Capture mirrors the natural workflow of sites maximizing efficiency, quality and speed. Ideal for users with any level of research experience, SureSource guides proper protocol execution while automatically validating data upon entry. SureSource Capture is a tablet-based application that mimics the familiar paper-pen interface, it was designed to look and feel just like familiar paper source. As such, each esource form can be fully customized and configured according to a specific study protocol. Clinical Reported Outcomes (ClinRO) SureSource Capture is completely configurable to support a variety of rated assessments within any therapeutic area including CNS and LUPUS studies. SureSource Capture can accommodate either study specific or industry recognized assessments. It is extremely helpful in studies where assessments forms can be lengthy and complex. Key features include: Rater instructions Edit checks to reduce errors Automatic calculations to eliminate errors Audio and video capture to record responses Remote access to source for Monitoring Observational and Performance Outcomes (ObsRO) & (PerfRO) SureSource Capture is ideal for quickly highlighting and capturing clinical observations and assessments. Since our solution is tablet based, it is very easy for clinicians and patients to quickly pass the tablet back and forth to perform tasks and capture data electronically. Key features include: Assessment instructions Highlighted required fields Ability to draw pictures Document patient /investigator signatures Switch modes between Patient and Clinician

3 Patient Reported Outcomes at Sites (epro) SureSource Capture is simply designed to emulate how you work with paper, so it is naturally intuitive and doesn t require patient based training. SureSource Capture offers a unique feature that lets patients fill out questionnaires in Subject User Mode that provides a complete audit trail within the system. Key features include: Intuitive design, no training required Edit checks to reduce errors Automatic calculations to eliminate errors Patient login credentials epro and Patient Engagement at Home From personalized reminders and study-specific content to remote data capture, SureSource Engage from Clinical Ink makes it easy to improve study efficiency while reducing research burden on patients and sites. Drive significant increases in adherence, retention and data quality with SureSource Engage. Patients simply download the SureSource Engage app to their iphone or Android device for convenient use as part of their daily lives.

4 The SureSource Engage app supports rapid study configuration and can deploy a fully functional solution for Patient Engagement, ecoa and connected devices in just a few weeks. This validated capability greatly reduces ramp-up time, development and testing efforts, and overall cost. Our SureSource offering fully supports BYOD or global provisioned deployment. Capture Remote Data Eliminate unnecessary site visits from monitors in your next trial using customizable questionnaires and direct capture from integrated sensors and wearables for remote esource and ecoa data collection. ecoa / epro Applications Configure electronic questionnaires and surveys to capture patientreported data conveniently from any location for real-time patient monitoring and improved data quality. esource and Sensor Data Use SureSource Engage to capture both esource and sensor data directly from patients using a variety of wearable medical devices for real-time, remote monitoring.

5 Improve Patient Engagement Patient engagement in clinical research improves retention, compliance and satisfaction by building mutually beneficial collaborations between patients and investigators, supported by useful tools like site scheduling and confirming patient visits. SureSource Engage helps you keep patients motivated, compliant and engaged via their personal smartphones. Reminders & Tasks Send personalized text message reminders and tasks to improve protocol and medication adherence. Appointments & Scheduling Schedule appointments and provide clinic information that appears directly on patients personal smartphone calendars. Content Library Educate and engage patients with convenient access to an informative library of study-specific content inside the SureSource Engage app. Status Tracker Personalized status trackers provide participants with study progress in real-time for added incentive to stay compliant and enrolled. Training and Compliance Convenient Online Training A convenient web-based training program is available anytime and from anywhere, SureSource University provides individual training to ensure complete familiarity with the SureSource platform. Following the webbased training, sites will require hands-on practice completing forms to ensure confidence when used with patients. Regulatory Compliant SureSource ensures ALCOA data and provides sites with a complete regulatory-compliant electronic audit trail at study close for convenient storage and access. 21 CFR Part 11 Compliant SureSource is validated for compliance with FDA Regulation 21 CFR Part 11 governing software used in clinical trials.

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