Clinsoft

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.