Average Ratings 0 Ratings
Average Ratings 0 Ratings
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
The elsai Clinical Protocol Audit Agent assists clinical and regulatory teams in ensuring that protocols, consent documents, and recruitment materials are properly aligned with governance standards prior to IRB submission. This innovative tool offers artificial intelligence-driven validation across multiple documents, tracks amendments and versions, identifies discrepancies automatically, provides governance and audit traceability, and delivers IRB-prepared review summaries. Additionally, it seamlessly integrates with CTMS, eIRB, eTMF, as well as Word and Google Docs workflows, enhancing overall efficiency and compliance in the clinical trial process. Its comprehensive features make it an invaluable asset for teams aiming to streamline their regulatory submissions.
API Access
Has API
Yes
API Access
Has API
No
Screenshots View All
No images available
Integrations
Medidata
Yes
Medrio
Yes
OpenClinica
Yes
Oracle API Catalog
Yes
REDCap
Yes
Veeva Vault
Yes
Zelta
Yes
elsai
No
Integrations
Medidata
No
Medrio
No
OpenClinica
No
Oracle API Catalog
No
REDCap
No
Veeva Vault
No
Zelta
No
elsai
Yes
Pricing Details
No price information available.
Free Trial
Yes
Free Version
No
Pricing Details
No price information available.
Free Trial
Yes
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
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
ClinVigilant
Founded
2017
Country
United Kingdom
Website
www.clinvigilant.com
Vendor Details
Company Name
elsai
Founded
2007
Country
United States
Website
www.elsai.ai/agents/clinical-protocol-audit-agent
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