AuroraPrime Connect
Remote Intelligent Clinical Study System

Prime Connect is a software system that supports remote clinical trials on the AuroraPrime clinical study platform. Designed with patient-centric approach, Prime Connect helps to implement full-process management in clinical trials through eConsent, TeleVisit, ePRO, Remote Monitoring, and Direct-to Patient (DTP). Prime Connect aims to help subjects reduce the cost of having to travel to and from the site to participate in clinical trials, lower subject dropout rate, and improve subject compliance. The system also helps investigators improve the efficiency and quality of data collection to make sound assessments and decisions about subjects' treatment results. Meanwhile, CRAs benefit from Prime Connect by travelling less to the site, thus saving costs while still conducting monitoring more timely and efficiently.

Modules
  • Subject-side APP

    Prime Connect's mobile subject management platform supports online and offline integrated modes to collect subject data, manage compliance, and optimize subjects' user experience throughout clinical trials using video, voice, notification and other mobile functionalities. The protection of subjects’ private information fully meets the legal and regulatory requirements and the data collection and reporting of subjects are real-time, continuous, and secure.
  • TeleVisit

    Prime Collect empowers clinical study investigators to operationalize Decentralized Clinical Trials (DCT), which has never been more relevant in today's social distancing and self-isolation climate. Designed with patient-centric approach, Prime Collect makes clinical trials more accessible to subjects, who can participate in trial visits from the comfort of their homes via web-enabled mobile devices, minimizing or eliminating the need to always have to travel long distances to physical sites. By providing an alternative to inflexible, site-anchored, in-person visits, which often result in a high patient drop out rate, the Prime Collect televisit solution not only helps to mitigate the challenges of travel restrictions posed by the Covid 19 pandemic that make physical access to patients difficult, but can also lead to flexible engagement with improved patient experience, faster onboarding, better retention, lower administrative burden and cost, and ultimately accelerated drug development and quicker time-to-market.
  • ePRO

    Prime Connect's electronic Patient-Reported Outcome (ePRO) provides a one-stop, worry-free solution for the entire process from scale copyright purchase, translation, selection, subject data collection, and statistical analysis during protocol design. Aiming at problems such as interpretation of subject scales during traditional paper input, difficulty in monitoring the timeliness of data entry, error-prone data, and archiving challenges. The ePRO module of Prime Connect can improve subjects' compliance, improve data integrity and compliance and quality and bring efficiency of clinical trials to the next level.
  • eConsent

    Prime Connect's eConsent (Electronic Informed Consent) allows subjects (with their guardians) and investigators to have an in-depth understanding of the information presented in the electronic consent form through video explanations and informed Q&A, and improve subjects' awareness of the content of informed consent. After fully acknowledging the contents of the informed consent form, subjects or guardians can digitally sign the consent form to improve subject retention and compliance. Trial sites and sponsors can also remotely screen, enroll subjects and approve of their participation in trials.
Features
  • Bring Your Own Device (BYOD)

    The Prime Connect APP supports subjects' installing and using their own devices, which increases the willingness of subjects to use the software and reduces trial costs. Subjects can participate in the trial on their mobile device and report AE data at any time. Subjects can join televisits from anywhere, reducing the difficulty of subjects participating in the trial, and improve compliance. Subjects can configure APP according to their own preferences and use the language of their choosing. Simple and user-friendly user interface (UI) reduces the learning curve. Subjects who encounter any issues during the trial can quickly find support from "Help Desk" through point of contact assigned.
  • TeleVisit

    The various video functions of Prime Connect support the investigator to complete the explanation of the informed consent form and scale during the visit, record the data collected during the visit, and reduce travelling costs for subjects, increase subjects' access to trials from remote areas, provide a safe and simple way to participate, and improve the quality and timeliness of data collection.
  • Remote Informed Consent

    Prime Connect supports the investigator in explaining the informed content to the subjects and their family members (or guardians) through video, and the shared screen helps the investigator to clearly identify the key content through visual means. Subjects and their guardians can complete the signing of the informed consent through electronic signatures anytime, anywhere, and the signed informed consent is stored in strict compliance with regulatory requirements. Subjects and their guardians can view, download the signed informed consent form.
  • Scale Library

    Prime Connect provides scale copyright purchase and translation services to facilitate project kick-off for sponsors. Standardized scales library can be directly used as per the visit schedule, improving the efficiency of protocol implementation. Custom scale configuration is flexible and supports a variety of scale forms and complex decision trees to provide more options for trials.
  • Centralized source data management

    Prime Connect allows administrators to grant PIs permissions to enter and modify source data according to the site's SOPs. Source data entered in the system according to study requirements can be used by investigators for compliance purposes such as printing and archiving. Authorized study personnel can access the source data.
Benefits
  • Lower clinical trial costs

    Prime Connect helps improve study accessibility and subject diversity, broadens the reach of a single study site, and minimizes personnel traveling to and from the site, thus cutting back on clinical trial time and costs.
  • Improved subject compliance

    Prime Connect can reduce the extra burden of participating in the study on subjects and reduce dropout rate. Flexible virtual sessions make visits less hindered and improve the overall quality of clinical trial data collection.

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