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Description
A standardized procedure for the management of investigational agents is essential to enhance patient safety while ensuring adherence to regulatory requirements. This process includes implementing safeguards to avoid the selection of expired or quarantined agents during dispensing, thereby reducing the chance of providing medication to patients not participating in a study. It is crucial to meticulously capture all dispensing details and document them in the Drug Accountability Record Form (DARF). Additionally, measures should be taken to prevent the distribution of drugs that may expire within the treatment period by thoroughly assessing the dispense date, available supply, and expiration date. Tracking details such as drug thaw time, reconstitution time, and temperature readings at the time of reconstitution is also vital. The centralized electronic management of investigational agents enhances clarity, minimizes paperwork and handwriting errors, and simplifies inventory management, allowing pharmacists to dedicate more time to critical tasks and patient care. Furthermore, while DARFs can be tailored using various filters, they still maintain a uniform appearance across all protocols, regardless of the sponsor involved, ensuring consistency and ease of use for all parties. This comprehensive approach to managing investigational agents ultimately contributes to a safer and more efficient clinical trial environment.
Description
Effectively monitor clinical trials from start to finish with Ennov’s comprehensive Clinical Trial Management software.
Each year, clinical trial sponsors search for new ways to improve the efficiency and reduce the costs associated with running their trials. Investigational site efficiency and productivity can be improved by centralizing information, actively monitoring progress, automating schedules, managing finances, and providing accurate reporting and metrics. With the Ennov CTMS, trial sponsors and CROs are able to actively address all aspects of trial management from a single platform: investigator sites, patients, SAEs, deviations, inclusions, visit reports, phone contacts, investigational product management, trial facilities, and finances. Study managers can plan and track their trials in real time to make better decisions faster. With the Ennov CTMS dashboard functionality, study personnel get on-demand analytics to improve quality, control risk, and reduce costs.
API Access
Has API
Yes
API Access
Has API
No
Integrations
Google Drive
No
Microsoft 365
No
Pricing Details
$17,000 per year
Free Trial
No
Free Version
No
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
No
Mac
No
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
No
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Ddots
Website
www.ddots.com/idea/
Vendor Details
Company Name
Ennov
Founded
1999
Country
France
Website
en.ennov.com/clinical-trial-data-management-system/ctms-clinical-trial-management-software/
Product Features
Product Features
Clinical Trial Management
21 CFR Part 11 Compliance
Yes
Document Management
Yes
Electronic Data Capture
Yes
Enrollment Management
Yes
HIPAA Compliant
No
Monitoring
Yes
Patient Database
Yes
Recruiting Management
No
Scheduling
Yes
Study Planning
Yes
