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What is Tepsivo?

Tepsivo presents cutting-edge software solutions for pharmacovigilance that streamline drug safety processes through automation and smart templates, resulting in a marked reduction in administrative burdens and associated costs. The Tepsivo Platform stands as a comprehensive, cloud-based tool that enables users to manage all elements of pharmacovigilance from a single, cohesive interface. Among its standout features are a Quality Management System, the guidance of a Local Contact Person for Pharmacovigilance (LCPPV), streamlined safety reporting and follow-up procedures, PSUR tracking, signal detection management, automated audit trails, compliance oversight, adverse event intake tools, literature monitoring, risk management system tracking, solutions for managing PSMF, automated reconciliation with external partners, and CAPA management. By incorporating these functionalities, the platform ensures total transparency, adherence to regulatory requirements, readiness for inspections, high-quality deliverables, swift processing times, removal of administrative overhead, and cost savings. Organizations utilizing Tepsivo’s solutions can significantly bolster their pharmacovigilance efforts while maintaining compliance with industry standards in an efficient and productive manner. Ultimately, this not only enhances safety management but also fosters a culture of continuous improvement within the organization.

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.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

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

Tepsivo

Company Location

Finland

Company Website

www.tepsivo.com/pharmacovigilance-software/

Company Facts

Organization Name

Clinevo

Company Location

United States

Company Website

www.clinevotech.com

Categories and Features

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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