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features
design
support

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Description

Streamline your clinical studies with Clinvigilant, your global cost-effective eClinical tools provider for CROs, Pharma, Biotech, Nutraceuticals and Academic organizations in clinical and post-marketing stages. Most of our clients choose and stay with us for thanks to our: ♦ Fast EDC set-up (less than 4 weeks). ♦ Cost-effectiveness. ♦ 3rd party integrations (including legacy systems). Our cloud-based suite (Microsoft Azure) is HIPAA, ICH-GCP, GDPR & 21 CFR part 11 compliant and we have been audited by the FDA, EMA and MHRA. The Clinvigilant eClinical suite includes: EDC, CTMS, eCRF, eTMF, eSource, IWRS, ePRO, eConsent and eCOA. Just pick the tools that you need and we will integrate them within your existing software ecosystem. Every interaction and data exchange creates Audit Trails, which provide compliant real-time data visibility across all relevant roles. Our products are modular, highly customizable, and available on the web, iPad, and Mobile App for both Android and iOS. We also support Patient's Own Device (BYOD) and interface with Devices and Wearables. Clinvigilant💊, your one-stop🌐solutions provider for clinical trials☁️ .

Description

WeGuide helps research teams, hospitals, pharma sponsors and CROs run studies and care programs on participants' own phones. One platform covers participant screening, eConsent with version control, re-consent tracking and audit trail, ePRO and PROM surveys, reminders and messaging, wearable data, patient registries and analytics. Wearable data comes from a native Garmin integration (including raw accelerometer and gyroscope data on supported models) and from Apple Health and Health Connect, which cover devices such as Apple Watch, Fitbit, Oura and Withings. Studies are BYOD first, and provisioned devices are supported when a protocol needs them. Data flows to REDCap through the REDCap API, and WeGuide also connects to Castor and Medidata Rave. WeGuide is Class I medical device software on the Australian Register of Therapeutic Goods (ARTG 355337), is ISO 27001 certified, and supports 21 CFR Part 11, HIPAA and GDPR requirements. Participant data is hosted in Australian data centres. In the BRACE trial led by Murdoch Children's Research Institute (6,800+ healthcare workers in five countries), participants logged daily symptoms in the WeGuide app. WeGuide Pty Ltd is a digital health company based in Melbourne, Australia, and a product from Curve Tomorrow.

API Access

Has API Yes 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

REDCap Yes 
Castor EDC No 
Medidata Yes 
Medrio Yes 
OpenClinica Yes 
Oracle API Catalog Yes 
Veeva Vault Yes 
Zelta Yes 

Integrations

REDCap Yes 
Castor EDC Yes 
Medidata No 
Medrio No 
OpenClinica No 
Oracle API Catalog No 
Veeva Vault No 
Zelta No 

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

Project based, all modules included in the core licence. Pricing on request.
Free Trial No 
Free Version No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App Yes 
iPad App Yes 
Android App Yes 
Windows Yes 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises Yes 
iPhone App Yes 
iPad App No 
Android App Yes 
Windows No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs No 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

ClinVigilant

Founded

2017

Country

United Kingdom

Website

www.clinvigilant.com

Vendor Details

Company Name

WeGuide Pty Ltd

Country

The Royal Children's Hospital, Ground Floor, 50 Flemington Road, Parkville VIC 3052, Australia

Website

www.weguide.health

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance Yes 
Document Management Yes 
Electronic Data Capture Yes 
Enrollment Management Yes 
HIPAA Compliant Yes 
Monitoring Yes 
Patient Database No 
Recruiting Management No 
Scheduling Yes 
Study Planning Yes 

Electronic Data Capture

Audit Trail Yes 
CRF Tracking Yes 
Data Entry Yes 
Data Verification Yes 
Distributed Capture No 
Document Imaging No 
Document Indexing No 
Forms Management Yes 
Remote Capture Yes 
Study Management Yes 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

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