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features
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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

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

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 

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