Average Ratings 0 Ratings
Average Ratings 0 Ratings
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.
Description
TrialPoint™ electronic data capture (EDC) is highly adaptable and user-friendly, earning the approval of coordinators everywhere. Our skilled data managers specialize in transforming clinical protocols into accessible metadata dictionaries, ensuring that TrialPoint™ is tailored to your needs rather than hindering your processes. The platform is capable of accommodating any randomization string, media uploads, or coding dictionaries, and it has the functionality to obscure treatment assignments from users. To enhance timely data collection, the system proactively determines visit windows and dispatches alerts and reminders, helping to keep the entire team aligned and on track. In the current landscape, incorporating patient-reported health outcomes and quality of life questionnaires is common in clinical trials, often leading to protocol adherence challenges. Explore TrialPoint's electronic patient-reported outcomes (ePRO) module, which can be customized to accommodate any quality of life questionnaire or patient diary, providing a seamless experience for participants. Ultimately, this flexibility not only facilitates compliance but also enhances the overall quality of the data collected in clinical trials.
API Access
Has API
No
API Access
Has API
No
Integrations
No details available.
Integrations
No details available.
Pricing Details
No price information available.
Free Trial
No
Free Version
Yes
Pricing Details
No price information available.
Free Trial
No
Free Version
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
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
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
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Atlant Systems
Founded
2010
Country
United States
Website
atlantsystems.com
Vendor Details
Company Name
Databean
Founded
2007
Country
United States
Website
databean.com/trialpoint/
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
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
Yes
Patient Database
No
Recruiting Management
No
Scheduling
No
Study Planning
No