TIMETOACT and Winchester Business Systems have combined forces to better market and support Winchester Business Systems Clinical Trials Management System (CTMS) in Europe. Together we will offer the full range of consulting, educating and supporting the product.
Winchester’s Protocol ManagerTM 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
What a CTMS is:
- A robust tracking tool and database designed to manage myriad trial information and metrics
- Subject Visits
- Monitoring Visits
- Provides automation and cross-trial/cross-program consistency
- Wide range of reporting options
- Metric measurements
Take the test – when does a company need a full-scope CTMS like Protocol Manager?
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.