Protocol Manager (CTMS) Description
Protocol Manager assists clinical operations in managing global trials for drugs, biologics, vaccines and other devices at all stages of development. Protocol Manager will help you comply with FDA's 21 CFR Part 11 regulations by ensuring that your company has implemented the right Standard Operating Procedures. Protocol Manager supports Web Services technology for seamless, automatic integration to many popular EDC or IVRS products. Integration is possible via an export/import method for systems that do not support Web Services. A database and tracking tool that can manage multiple trial information and metrics.
Protocol Manager (CTMS) Alternatives
Medrio
Medrio's Electronic Data Capture (EDC) platform and complimenting eClinical solutions such as ePRO, RTSM, eConsent, and Direct Data Capture (DDC) have been trusted by major pharmaceutical, biotech, CRO, animal health, medical device, and diagnostic companies since 2005.
We are known for our easy-to-use solutions, delivering speed and simplicity to clinical trials of all phases, sizes, and complexities. Medrio users can build their databases in an average of 2.8 weeks with no programming required, make mid-study changes with just a few clicks of a mouse, and much more.
From bolt-on capabilities to full-service offerings, Medrio offers flexible, modular solutions that give our customers exactly what they need – and none of what they don’t. Our innovative software, as well as the robust and flexible training and support resources we provide our customers, have earned us a 98% customer satisfaction rating.
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Chronicles CTMS
Full cycle product for Research and Development Teams in the Pharmaceutical Industry. The product includes Electronic Trial Master File and Trial Management. It also has Electronic Document Management with eSignature support. This product is suitable for areas regulated by 21CFR Part 11 requirements.
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BREEZE CTMS
Electronic source documents - eSource – eliminate paper, standardize and simplify workflow and reduce errors and omissions. BREEZE eSource does more than just schedule visits and create templates. BREEZE eSource synchronizes clinical contexts, regulatory requirements, and protocol requirements with study procedures. This ensures that users capture all protocol-required data. BREEZE business rules ensure that data collected is accurate, complete, accurate, and in compliance with regulations. Our dedicated team of clinical trial specialists delivers customized, study-specific eSource documents to review and approve before study start-up. They also support you throughout the trial by modifying them as necessary. Modules work seamlessly together. Cross-Module Action Multiplier takes things one step further, anticipating and completing automatically any additional tasks you enter. For example, the completion of visits or procedures automatically posts invoicing, recalculates scheduling, etc.
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ClinSoft
ClinSoft™, was developed in-house by Innovate Research. There were no third-party acquisitions and integrations. The system is compliant to FDA regulations (21 CFR Part 11, as well as GCP and HIPAA. The system is fully auditable and validated. ClinSoft™, which is easy to use, ensures quick start-ups and close-outs. This saves you precious time and allows you to be certain that any mid-study amendments or updates to protocols will be made promptly. Innovate Research, an Indian contract research company, provides services in clinical research and regulatory affairs. US FDA 21 CFR Part 11 compliant. Electronic Signatures & Records Secure, Role-Based Access. Audit Trail. Easy to use interface for Edit Checks and CRF Set-up. Frameworks that can be reused for item, panel, visit, and page.
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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
Media
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Product Details
Platforms
SaaS
Windows
Mac
Type of Training
Documentation
Live Online
Customer Support
Phone Support
Online
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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