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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 Biorce Aika?

Biorce's Aika is an innovative AI-powered clinical intelligence platform that revolutionizes the clinical trial lifecycle by converting labor-intensive processes for protocol creation and feasibility assessments into streamlined, evidence-based automation. Drawing on insights from nearly one million real-world trials, Aika can rapidly generate initial study protocols, detailed regulatory documents, site feasibility assessments, risk management plans, and other essential components of trials much quicker than traditional methods, thus reducing the likelihood of delays and costly revisions. This platform promotes complete transparency in its recommendation processes, empowering teams to confidently convey their decisions to regulatory bodies while ensuring expert supervision remains intact. Furthermore, Aika effectively marries the rapid efficiency of AI with deep clinical expertise, significantly shortening trial preparation durations from weeks to just days, which minimizes amendment risks and overall project vulnerabilities. By integrating seamlessly into current workflows without necessitating extensive retraining, Aika allows clinical trial teams to prioritize strategic decision-making over tedious administrative responsibilities. As a result, the focus shifts towards enhancing trial outcomes and optimizing resource allocation, ultimately driving innovation in clinical research practices.

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

Pricing not provided
Free Trial Offered?

Supported Platforms

SaaS
Windows
Mac

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub
Online Training

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

Atlant Systems

Date Founded

2010

Company Location

United States

Company Website

atlantsystems.com

Company Facts

Organization Name

Biorce

Date Founded

2024

Company Location

Spain

Company Website

www.biorce.com/our-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

Healthcare AI

Not specified

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