PROTOCOL MANAGER

PROTOCOL MANAGER

PROTOCOL MANAGER 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