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What is Protocol Manager (CTMS)?

The Protocol Manager plays a crucial role in clinical operations by managing global trials across different phases of drug, device, biologic, and vaccine development. It establishes essential Standard Operating Procedures (SOPs) to ensure adherence to FDA's 21 CFR part 11 regulations. Utilizing Web Services technology, the platform enables seamless and automatic integration with a variety of popular EDC and IVRS solutions. For systems that do not support Web Services, an export/import feature is provided to facilitate integration. This all-encompassing tool includes a robust tracking system and database, enabling effective management of diverse trial information and metrics, which significantly boosts operational efficiency. Furthermore, it allows organizations to uphold stringent oversight throughout the trial process, safeguarding data integrity and ensuring compliance at each phase. As a result, the Protocol Manager not only streamlines operations but also supports the successful execution of clinical trials by promoting transparency and accountability.

What is Folio3 Clinical Trial Management?

Folio3 Digital Health presents a comprehensive Clinical Trial Management Software (CTMS) designed as a web-based solution to significantly improve the overall effectiveness of the clinical trial lifecycle for pharmaceutical companies, contract research organizations (CROs), and research institutions. This innovative platform integrates multiple trial operations, streamlining processes from planning and site management to data collection and reporting while ensuring compliance with international standards such as FDA 21 CFR Part 11, GxP, and HIPAA regulations. With an emphasis on user-friendly interface designs and real-time dashboards, the software is adept at managing clinical trials of all sizes efficiently. Included in the system are specialized modules for initiating studies, which allow users to define protocols, establish timelines, and create budgets through customizable templates that meet their specific requirements. Additionally, the site management capabilities facilitate the tracking of investigator credentials, contracts, and financial transactions, alongside patient recruitment features that simplify the screening process, monitor enrollment, and organize visit schedules, complete with automated reminders to boost participant involvement. The platform's adaptable nature ensures its relevance for a variety of stakeholders in clinical research, ultimately fostering a more cohesive and effective trial management experience, which is essential for advancing medical knowledge and improving patient outcomes. Furthermore, its robust analytics tools provide valuable insights that can enhance decision-making throughout the trial process.

Media

Media

No images available

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided
Free Version

Pricing Information

$300

Supported Platforms

SaaS
Windows
Mac

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Not specified

Company Facts

Organization Name

Atlant Systems

Date Founded

2010

Company Location

United States

Company Website

atlantsystems.com

Company Facts

Organization Name

Folio3 Digital Health

Date Founded

2005

Company Location

United States

Company Website

digitalhealth.folio3.com/solutions/clinical-trial-management-software/

Categories and Features

Clinical Trial Management

21 CFR Part 11 Compliance
Document Management
HIPAA Compliant
Monitoring
Patient Database
Scheduling
Study Planning

Categories and Features

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