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What are the 6 steps are followed using ASCEND CTMS for Clinical Trial Management?
1. Site Selection and management
2. Regulatory Documentation Tracking
3. Subject Recruitment Tracking
4. Investigator Payment Management
5. Study and Site monitoring
6. Study and Site closeout tasks management
What are some of the things you can track w/ ASCEND?
Site and subject data including:
- site initiation
- subject recruitment
- monitoring visits
- site issues
- protocol deviations & more
What financial info does ASCEND track?
- Protocol expenses
-and Streamlines investigator payments
What does ASCEND's Investigator database provide?
- robust investigator database
- complex search capability for more targeted site selection
How are trip reports managed in ASCEND?
- It provides trip report review and approval directly in the application with approval and status history
What does ASCEND's streamlined administration capacity do?
It consolidates multiple administration screens into one.
What is ASCEND?
A program which uses Oracle's Siebel Clinical Trial Management system.
In the Clinical Trial setting, the software applications used are commonly referred to as what?
eClinical Systems/Solutions
What do Clinical Trial Management Systems (CTMS) focus on?
the operational side of the trials
What does the Electronic Data Capture(EDC) system focus on?
the collecting and managing the clinical data.
What are The Clinical Trial Management Systems (CTMS)?
CTMS = web-based application for efficient management of Clinical Trial Operations with an aim to streamline clinical trial processes, enable sharing consistent trial information across the enterprise and manage relationships with trial participants, especially investigators and subjects.
What features does a typical CTMS application have?
It has features such as Project Management, Site Management, Payments, Protocol Deviations, Site Visit and Trip Reports, Milestone Tracking, Patient Recruitment, etc.
Which CTMS vendors are the main players in the top 30 biopharma sectors?
1. Oracle's Siebel eClinical
2. Perceptive Informatics's IMPACT and
3. Winchester Business Systems' Protocol Manager