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What is SimpleTrials?

SimpleTrials is a subscription-based, on-demand Clinical Trial Management System (CTMS) specifically designed for sponsors, Contract Research Organizations (CROs), and research facilities. It offers a comprehensive suite of tools that streamline the planning, management, and oversight of clinical study portfolios, including features for site initiation, subject monitoring, and document management via an integrated electronic Trial Master File (eTMF). Users can take advantage of real-time analytics for their studies, detailed calendars, customizable fields and trackers, on-demand reporting, planning milestones, and the management of site contracts and payments, along with electronic documentation of visits. The platform is constructed to adhere to 21 CFR Part 11 compliance standards, providing a secure and validated environment for the handling of clinical trial data. Additionally, users can customize their tracking views, seamlessly connect with various Electronic Data Capture (EDC) systems, and utilize pre-built templates for consistent document management. By fostering enhanced collaboration among all stakeholders, the system supports more effective communication throughout the entirety of the trial process, ultimately leading to improved outcomes and efficiency in clinical research.

What is ClinSoft?

ClinSoftâ„¢, created internally by Innovate Research, does not involve any external acquisitions or integrations. The software adheres to FDA regulations, including 21 CFR Part 11, GCP, and HIPAA standards, ensuring it is both fully auditable and validated. This user-friendly system facilitates rapid start-up and close-out processes, allowing you to save valuable time and guaranteeing that any amendments or updates to study protocols are implemented efficiently. As a contract research organization based in India, Innovate Research specializes in clinical research and regulatory affairs, ensuring compliance with US FDA 21 CFR Part 11. The platform features secure electronic signatures and records, role-based access control, and an audit trail. Moreover, it includes an intuitive interface for editing checks and setting up case report forms (CRFs), along with reusable frameworks for items, panels, visits, and pages, enhancing usability and efficiency for clinical trials. Additionally, the comprehensive design of ClinSoftâ„¢ supports streamlined workflows, ultimately improving overall productivity in clinical research operations.

Media

Media

Integrations Supported

REDCap

Integrations Supported

REDCap

API Availability

Has API

API Availability

Has API

Pricing Information

$849 per month
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

SimpleTrials

Date Founded

2008

Company Location

United States

Company Website

www.simpletrials.com

Company Facts

Organization Name

Innovate Research

Date Founded

2014

Company Location

India

Company Website

innovate-research.com/clinsoft/

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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