Winchester Business Systems - CTMS

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CTMS - Protocol Manager

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Summary		Overview		Options and Integration

Winchester’s Protocol Manager^TM is a full-scope, configurable, off-the-shelf Clinical Trials Management System (CTMS). Protocol Manager helps clinical operations manage global trials of drugs, devices, biologics, and vaccines in all phases of development. When the appropriate Standard Operating Procedures (SOPs) are implemented in your company, Protocol Manager can help you be compliant with the FDA’s 21 CFR part 11 regulations

Take the test – when does a company needs a full-scope CTMS like Protocol Manager?

CTMS Test
Score (0 – No Problem to 10 – Big Problem)

Number of trials is increasing ______
Number of sites on a trial is increasing ______
Number of patients/subjects on a trial is dramatically increasing – moving from Phase I to II or Phase II to III trials ______
Regulatory documents are difficult to manage – regulatory documents are different by role when a trial crosses international boundaries ______
Must reinvent letter and regulatory Document Templates for each trial ______
Getting sites initiated has become difficult ______
Keeping a database of accurate site information is complex ______
Paying investigators is complex ______
Patient/subject cohort management is complex ______
Managing contractor invoices is complex ______

Total >>> ________

If your score is over 25, you possibly need a CTMS.
If your score is over 35, you need a CTMS.
If your score is over 50, you are in desperate need of a CTMS.

What a CTMS is:

A robust tracking tool and database designed to manage myriad trial information and metrics
- Subject Visits
- Monitoring Visits
- Documents
- Payments
- Inventory
Provides automation and cross-trial/cross-program consistency
Wide range of reporting options
Metric measurements

What a CTMS is NOT:

Electronic Data Capture (EDC) system
Clinical Data Management System (CDMS)
Replacement for good hands-on study management
Automation of program management

To request a demo, click here.

To download the brochure, click here.

To view an interactive flash presentation on Protocol Manager, click here .

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Features and Benefits




	On-line and off-line use
	Hosted and/or licensed use
	E-Mail freedom for alerts
	Investigator Payments
	21 CFR Part 11 Compliance
	Industry Standard Security
	Templates for ease of use and efficiency
	Powerful Business Development Module
	Manages site contracts and payments
	Realtime Site Portal
	Time & Expense Reporting