Name: Clinsoft
Author: Innovate Research

Communications Outsourcing

Help Desk

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Text Editors

Development

Business Intelligence (BI)

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Desktop Publishing

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Interactive Voice Response (IVR)

Meeting Management

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Accounting

Blockchain Payments

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Applicant Tracking

Corporate Learning Management

Employer of Record (EOR)

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Stock Option Plan Administration

Talent Intelligence

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Cloud Storage

Continuous Delivery

Data Fabric

Endpoint Encryption

Enterprise Backup

File Sync and Share

Firewall

Fraud Detection

IT Service Management (ITSM)

Infrastructure Capacity Planning

Integration Platform as a Service (iPaaS)

Network Operating Systems

Network Performance Monitoring

Network Traffic Analysis (NTA)

Network Virtualization

Phishing Detection and Response

Virtual Desktop Infrastructure (VDI)

Voice Recognition

Web Application Firewalls

Web Scraping

Zero Trust Security Solutions

Information Technology

A/B Testing

Ad Serving & Retargeting

Advertising Agency

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Business Card Scanning

Content Management

Digital Experience Platforms (DXP)

Email Marketing

Graphics

Location Intelligence

Marketing Automation

Social Media Management

Survey & Forms Building

Translation

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Marketing

Professional Services Automation

Project Management

Professional Services

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Proposal

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Operational Technology (OT) Security

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Auto Repair

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Homeowner's Association (HOA) Management

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ClinSoft is a clinical trial management system developed by Innovate Research. According to the vendor, it is designed to optimize the clinical trial process, from Phase II to Phase III trials. The system targets small to large pharmaceutical and biotechnology companies, contract research organizations (CROs), academic research institutions, and government agencies involved in clinical research.

## Key Features

According to the vendor, ClinSoft offers the following features:

**Clinical Trial Management System**: ClinSoft enables quick start-up and close-out of studies, allowing for mid-study updates or amendments to protocols.

**US FDA 21 CFR Part 11 Compliance**: ClinSoft is compliant with the US FDA 21 CFR Part 11 regulations, providing secure, role-based access, electronic signatures, and records. It maintains an audit trail to track and document system activities.

**Intuitive User Interface**: ClinSoft offers an intuitive and user-friendly interface for setting up Case Report Forms (CRFs) and edit checks. The vendor claims it reduces the need for programming, saving time and effort during study set-up.

**High System Scalability**: ClinSoft is designed to handle large-scale clinical trials, accommodating multi-site and multi-user trials. According to the vendor, it facilitates efficient collaboration and data management across multiple sites and users.

**Customized Reporting & Dashboards**: ClinSoft provides customized reporting and dashboards tailored to specific study requirements. Project dashboards offer a comprehensive view of study progress and key metrics, while adhoc reports allow for in-depth analysis and visualization of study data.

**Study Documents Repository**: ClinSoft includes a study documents repository for centralized storage and management of study-related documents. According to the vendor, it ensures easy access, retrieval, version control, and document traceability for study personnel.

**Double Data Entry (DDE) and Comparison Reconciliation**: ClinSoft supports double data entry (DDE) to enhance data accuracy and reliability. It also provides a comparison reconciliation feature to identify and resolve discrepancies in entered data.

**Compliance with Regulatory Requirements**: ClinSoft is compliant with FDA requirements (21 CFR Part 11), Good Clinical Practice (GCP), and the Health Insurance Portability and Accountability Act (HIPAA). The vendor claims it provides a validated system with a full audit trail.

**Efficient Study Set-up**: ClinSoft enables quick start-up and close-out of studies, potentially saving time during the study. According to the vendor, it allows for mid-study updates or amendments to protocols to be promptly adjusted.

**Robust Data Management**: ClinSoft offers robust data management capabilities, ensuring efficient collaboration, data integrity, and confidentiality. It supports secure role-based access and maintains an audit trail to track system activities.

The MasterControl Quality Excellence suite bundles a number of products supporting work quality and compliance including training and exams, incidents and corrective actions (CA), documents and change, and other modules.

MasterControl Quality Excellence

Clinsoft

A Clinical Trial Management System(CTMS) supports research institutes and pharmaceutical to run clinical studies with human subjects. Therefore they store subject information and support research operations with planning, benchmarking, and reporting features, and also should integrate with a business intelligence or analytics platform, if it does not contain such features intrinsically.

Clinical Trial Management

Innovate Research

TrustRadius is a technology and business research firm based in Austin, Texas. The company is known as a review platform for verified B2B technology and software reviews through a proprietary algorithm and human verification.

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Clinsoft

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What is Clinsoft?