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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 BizNet?

Accelerate clinical innovation with an AI-enabled Clinical Research Platform that unifies Early Phase CTMS, Late Phase CTMS, and Bioanalytical LIMS into a single, intelligent ecosystem. Purpose-built for pharmaceutical, biotechnology, and CRO organizations, the platform streamlines the complete clinical development lifecycle, from protocol planning, volunteer and patient management, site operations, study execution, and sample lifecycle management to bioanalytical testing, data review, and regulatory reporting. AI-powered capabilities such as intelligent workflow automation, predictive analytics, anomaly detection, smart data validation, and real-time decision support help research teams identify risks early, optimize resources, reduce manual effort, and make faster, data-driven decisions. A key differentiator is its unified CTMS-LIMS architecture, eliminating data silos while ensuring seamless data flow, end-to-end traceability, and operational transparency across clinical and laboratory functions. Configurable workflows, role-based dashboards, automated alerts, and enterprise integrations with EDC, eTMF, ERP, and laboratory instruments enhance collaboration and study oversight. Built on a scalable, GxP-compliant framework supporting GLP, GCP, and 21 CFR Part 11, the platform delivers audit-ready documentation, electronic records, secure access controls, and complete data integrity. By combining AI-driven intelligence with compliance, interoperability, and operational excellence, it empowers sponsors and CROs to accelerate trials, improve study quality, and bring therapies to market faster.

Media

Media

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

$79
Contact Sarjen Systems Pvt Ltd.

Supported Platforms

SaaS
Windows
Mac

Supported Platforms

SaaS
Windows
On-Prem

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Atlant Systems

Date Founded

2010

Company Location

United States

Company Website

atlantsystems.com

Company Facts

Organization Name

Sarjen Systems Pvt Ltd

Date Founded

1998

Company Location

India

Company Website

biznet.sarjen.com

Categories and Features

Clinical Trial Management

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