Protocol Manager (CTMS) Description
Protocol Manager is instrumental for clinical operations in overseeing global trials across various phases of drug, device, biologic, and vaccine development. By implementing the necessary Standard Operating Procedures (SOPs), Protocol Manager ensures compliance with the FDA’s 21 CFR part 11 regulations. The platform utilizes Web Services technology to facilitate effortless and automatic integration with numerous widely-used EDC and IVRS solutions. For those systems that lack Web Services compatibility, an export/import mechanism is available for integration. This comprehensive tool features a powerful tracking system and database that effectively manages a wide range of trial information and metrics, enhancing overall operational efficiency. Additionally, it empowers organizations to maintain rigorous oversight throughout the trial process, ensuring data integrity and compliance at every stage.
Protocol Manager (CTMS) Alternatives
KrakenD
Engineered for peak performance and efficient resource use, KrakenD can manage a staggering 70k requests per second on just one instance. Its stateless build ensures hassle-free scalability, sidelining complications like database upkeep or node synchronization.
In terms of features, KrakenD is a jack-of-all-trades. It accommodates multiple protocols and API standards, offering granular access control, data shaping, and caching capabilities. A standout feature is its Backend For Frontend pattern, which consolidates various API calls into a single response, simplifying client interactions.
On the security front, KrakenD is OWASP-compliant and data-agnostic, streamlining regulatory adherence. Operational ease comes via its declarative setup and robust third-party tool integration. With its open-source community edition and transparent pricing model, KrakenD is the go-to API Gateway for organizations that refuse to compromise on performance or scalability.
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FusionAuth
FusionAuth is the authentication and authorization platform engineered for developers who demand flexibility and control. Built from the ground up to integrate with any stack, every feature — from user registration to MFA and SSO — is exposed via a modern, well-documented API.
Support for every major identity protocol is included out of the box: OIDC, SAML, OAuth2, JWT, passwordless login, social sign-on, and more. Whether you’re building a greenfield app or retrofitting auth into a legacy system, FusionAuth adapts to your use case — not the other way around.
Need compliance? FusionAuth helps you meet GDPR, HIPAA, and COPPA standards quickly and reliably.
Deploy it your way: install on Linux, Windows, macOS, Docker, or Kubernetes — or go with FusionAuth Cloud, our managed SaaS hosting. No black boxes. No vendor lock-in. Just powerful, customizable auth that works the way you do.
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Castor EDC
Castor offers an intuitive and comprehensive platform for managing clinical trial data, focusing on electronic data capture (EDC), eConsent, and patient-reported outcomes (ePRO). The platform is optimized for decentralized trials, providing seamless tools for remote patient engagement and data collection. With real-time reporting, Castor helps researchers track trial progress and make data-driven decisions. The solution ensures compliance with industry regulations such as HIPAA, GDPR, and 21 CFR Part 11, making it ideal for life sciences organizations looking to enhance trial efficiency while maintaining high data integrity.
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eDeviation
eDeviation provides comprehensive tools for assessing and managing Protocol Deviations. It streamlines processes from software design and validation to gathering necessary documentation and exporting information for the Trial Master File (TMF), thereby alleviating the burden on clinical teams who may face risks from improperly assessed or overlooked protocol deviations, whether they occur once or multiple times. As a component of Ethical's eClinical Software Platforms, eDeviation® enhances the efficiency and accuracy of clinical trial management. Whether evaluations are conducted by a dedicated independent committee or by your own research team, our software can be tailored to meet your specific requirements. The integration of forms, workflows, and export functions ensures adherence to GxP standards and fosters effective study management. Additionally, this platform allows study teams, investigators’ sites, and committee members to collaborate online in real-time, facilitating quicker decision-making, reaching consensus, and ensuring the prompt handling of protocol deviation assessments and management. Ultimately, eDeviation® enhances the overall integrity and efficiency of clinical trial processes, contributing to better outcomes in research.
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Pricing
Free Version:
Yes
Integrations
No Integrations at this time
Company Details
Company:
Atlant Systems
Year Founded:
2010
Headquarters:
United States
Website:
atlantsystems.com
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Product Details
Platforms
Web-Based
Windows
Mac
Types of Training
Training Docs
Live Training (Online)
Customer Support
Business Hours
Online Support
Protocol Manager (CTMS) Features and Options
Clinical Trial Management Software
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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