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features
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support

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Description

Biorce’s Aika represents a groundbreaking AI-driven clinical intelligence platform that enhances every phase of the clinical trial lifecycle by transforming slow, manual processes for protocol development and feasibility assessments into efficient, evidence-based automation. Leveraging insights from approximately one million real-world trials, Aika can swiftly produce first-draft study protocols, comprehensive regulatory documentation, site feasibility evaluations, risk management strategies, and other critical trial components significantly faster than conventional approaches, which helps in minimizing delays and expensive modifications. Aika not only ensures complete transparency in its recommendation processes, allowing teams to confidently communicate their decisions to regulators while retaining expert oversight, but also effectively combines the rapid capabilities of AI with the depth of clinical knowledge. By drastically reducing trial preparation times from weeks to mere days, it significantly decreases the chances of amendments and mitigates overall risk, all while seamlessly fitting into existing workflows without the need for extensive retraining. With Aika, clinical trial teams can focus more on strategic decision-making rather than being bogged down by administrative tasks.

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.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

No price information available.
Free Trial Yes 
Free Version No 

Pricing Details

No price information available.
Free Trial No 
Free Version Yes 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows No 
Mac No 
Linux No 
Chromebook No 

Deployment

Web-Based Yes 
On-Premises No 
iPhone App No 
iPad App No 
Android App No 
Windows Yes 
Mac Yes 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) No 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

Biorce

Founded

2024

Country

Spain

Website

www.biorce.com/our-software

Vendor Details

Company Name

Atlant Systems

Founded

2010

Country

United States

Website

atlantsystems.com

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance No 
Document Management No 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant No 
Monitoring No 
Patient Database No 
Recruiting Management No 
Scheduling No 
Study Planning No 

Product Features

Clinical Trial Management

21 CFR Part 11 Compliance Yes 
Document Management Yes 
Electronic Data Capture No 
Enrollment Management No 
HIPAA Compliant Yes 
Monitoring Yes 
Patient Database Yes 
Recruiting Management No 
Scheduling Yes 
Study Planning Yes 

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