- Video meetings for site-patient assessments
- Remote consent and patient engagement
- IRT deployed in days, not weeks
- Global eCOA on a proven platform
- Scientific guidance and endpoint data quality
REMOTE TRIALS WITH SIGNANT HEALTH
These days, patients may not need need to come to a clinic, site, or hospital in order to participate in clinical trials. Instead, trials have evolved alongside key advancements in technology, enabling patients to complete the entire trial, or a part of it, from the comfort of their own home.
At Signant, we offer a broad set of remote trial components that enables you to choose which portions of the trial to conduct remotely. You can count on us for experience, technology, and the knowledge to help you administer aspects of your trial remotely, in a way that’s best for your patients, sites, and study teams.
CONNECTING PATIENTS, SITES, AND STUDY TEAMS
Video Meetings and Patient Engagement
Now featuring video calls for complex remote clinician assessments, Signant’s Patient Engagement application TrialGuide is designed to simplify the lives of patients and sites worldwide, guiding them towards your trial’s key milestones. With TrialGuide, you receive:
- Video visits for patient and site interactions, ensuring that the same rapport and relationships established in office, continue remotely.
- Patient reminder notifications such as SMS, email, and in-app notifications
- Patient engagement features such as resource libraries, visits-by-visit guide, visit schedule and reminders, caregiver support, integration with third-party patient reimbursement solutions, gamification, patient surveys, and more.
Responsive: Dynamic scale-up bandwidth over Wi-Fi & cellular connection to maintain call
Compliant: Meets HIPAA standards, GDPR compliant
Secure: TrialGuide features end-to-end encryption while also requiring that the site and patient must be logged into TrialGuide in order to start the video visit
Auditable: Audit logs include date/time of call, duration of call, and call participants
Remote Consent with TrialConsent
With TrialConsent, your patients can access the entirety of the consent process from home, moving through the process at their own pace
Patients start by accessing credentials issued automatically to their verified email. From here, they can access your study’s consent documents ahead of visits or continue with the full consent consenting process without attending site.
TrialConsent ensures that your patients understand what’s being asked of them by requiring that they flag sections as “understood”, or “have questions for the investigator” as they move through the consent process. With remote consenting, the review of these sections and questions can be performed by phone or video meeting with the site staff or via healthcare professionals at a delegated call centre. TrialConsent can enhance and result in more focused direct-to-patient interaction by the sites, and allows this interaction to be maintained as a core component of the remote consent process. Patients and sites have full access to view and download signed consent forms.
Direct to Patient IRT
It’s no secret that direct-to-patient IRT models have been in the spotlight recently. With disruptions to trials worldwide, what was once seen as a unique tool for only a select few trials is now a “must have.”
In a remote trial or hybrid trial design, where some visits are done in clinic and some at home, there are two general “direct to patient” (DtP) models that can be applied. These are Depot to Site to Patient, or Depot to Patient
- In a Depot to Site to Patient model, patients are allocated the study drug(s) directly from site inventory. This is normally done with a standard “study visit” or similar transactions in IRT. From here, last mile delivery logistics are handled by the site or local pharmacy. This may include local courier services, home health services or direct site personnel facilitating delivery.
- Depot to Patient models facilitate direct delivery to a patient of medication from a central (non-site based) warehouse. This may be the same depot which supplies sites, or in many cases, a specialized central pharmacy which is able to handle the logistics of patient delivery, as specified by the IRT.
A Trusted eCOA Platform
It only takes a handful of poorly administered clinician or patient ratings to be problematic for study data. At Signant, we’ve worked to ensure that data quality standards remain high, no matter where your study takes place. Our clinical scientists work with sponsors and scale authors to evaluate how best to implement remote assessments where these are under consideration.
With over 20+ remote rater assessment studies complete, we offer customers:
- Telephone or video remote assessments in addition to, or instead of, site-based assessments
- HIPAA-compliant video technology solution
- CNS / neurology and other therapeutic areas
- Remote training of your raters, for accurate remote assessments
- A vendor that works with scale authors to ensure equivalence and acceptability
- Throrough-study monitoring of ongoing rater-reliability
- Clinical reviews of recorded interviews
- Central rating services in addition to, or instead of, site-based raters
- Network of 250+ active clinical consultants
- 16 disease indications
Data Quality Analytics
Gain Real-Time Actionable Insights About Your Study’s Data Quality
Our Data Quality Analytics solution uses advanced analytics to identify data inconsistencies introduced while your study is ongoing. It even predicts where they may arise before your study starts. Results are displayed in intuitive, color-coded charts and graphs, making them easy to interpret. If you need help formulating a corrective action plan, our Scientific & Clinical team will help you determine the best path forward.
Gain piece of mind with:
- Evidence-based algorithms to identify study endpoint quality risks
- Clinical data scientist monitoring of ongoing data quality
- Ongoing inter- and intra-rater reliability assessment
- Consistency of site-based and remote assessments
Clinical Data Collection: ePRO, Sensors, ePerfOs, Sensors and Wearables
Modern studies require modern solutions. As more trials include more remote components, you can count on us and our experience in simply and easily collecting patient data across interconnected devices in over 1,000+ trials worldwide.
A Flexible Multi-Mode ePRO Platform
- Choose from a provisioned device, or enable your patients to bring your own device (BYOD)
- Compatible with any device that uses modern web browsers
- Flexibility for at-home and site-based assessments
- Web backup
- Single-device solution for studies requiring both site- and home-based PROMs
Choose the Right Type of Device for Your Trial
- Lung function
- Smart Inhalers
- Blood Glucose
GO REMOTE WITH SIGNANT HEALTH
Begin a conversation or request a demo of our technology to see what is possible in the new normal and beyond.