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What is Clienvo eTMF?

Clinevo's electronic Trial Master File (eTMF) provides a streamlined digital platform for the organization and archiving of documents, images, and various digital assets pertinent to clinical trials. This eTMF is designed with an integrated DIA reference model and adheres to regulatory requirements. In addition to this, Clinevo features the MICC Intake, a web-based tool tailored for Medical Information Call Centers (MICC) and Pharmacovigilance (PV) experts, enabling them to efficiently log, track, and manage Product Quality Complaints (PQCs), Medical Inquiries (MIs), and Adverse Events (AEs). Moreover, Clinevo Safety acts as a robust cloud-based system that simplifies the Pharmacovigilance process while ensuring compliance with regulations, covering PV Intake, Case Processing, Regulatory Submissions/AS2 Gateway, Analytics, and Safety Signals all within one unified platform. Additionally, the Clinevo Website Intake tool can be easily integrated with Sponsor or CRO websites, providing an intuitive web interface for consumers and reporters to access and submit reports effortlessly. This comprehensive range of tools not only streamlines clinical trial management but also significantly enhances safety reporting efficiency and effectiveness. Ultimately, Clinevo's innovative solutions are designed to meet the evolving needs of the clinical research landscape.

What is BSI CTMS?

BSI CTMS stands out with its cutting-edge interface and smart data visualization features. Our software for managing clinical trials goes beyond mere aesthetics, providing essential tools that support pharmaceutical, biotech, and diagnostics sponsors, as well as contract research organizations (CROs) and academic sites (SMOs), in efficiently overseeing their clinical trials. The ongoing development of BSI CTMS is driven by market demands and involves collaboration with industry stakeholders. What sets BSI CTMS apart is its comprehensive offering that combines CTMS, eTMF, and Study Startup capabilities into a single integrated platform. Unlike traditional standalone solutions like Excel, which fall short in functionality, our software provides a cohesive experience for users. This integration not only streamlines workflows but also enhances overall productivity in the clinical trial process.

Media

Media

Integrations Supported

SMART-TRIAL

Integrations Supported

SMART-TRIAL

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Clinevo

Company Location

United States

Company Website

www.clinevotech.com

Company Facts

Organization Name

BSI Business Systems Integration AG

Date Founded

1996

Company Location

Switzerland

Company Website

www.bsi-lifesciences.com/solutions/ctms.html

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning

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