CTMS: Simplifying Complex Study Protocols

One change in clinical research everyone is feeling is the consistent increase in the complexity of protocol designs for new studies. Regardless of the causes of this increase in complexity, it is something research organizations need to effectively manage in order to remain profitable. This task is often easier said than done. Complex protocols have a negative effect on data quality and analysis, cause greater amounts of unused trial data, increase dropout rates, and lower physician participation levels. What’s worse, complex protocols often become more complex as a trial progresses. Oftentimes, multiple protocol amendments are made on a single study, which can cost hundreds of thousands of dollars to implement and waste months of time.

If you are a research site, academic research organization, CRO, or any other organization involved in the research process, it is important to keep up with the constant changes in your trials so you can minimize loss and maximize quality. Below are a couple of ways your CTMS helps lessen the impact from complex trial protocols and the constant state of change they keep you in:

Consent Form Management

The best CTMS applications will allow you to ensure all patients in a trial are up-to-date on the latest consent forms. You can see which patients have signed the latest form and those that have not, and you can avoid wasting time and money conducting procedures on those why aren’t on the latest consent form. This is an important step because it will allow your organization to minimize unused trial data and will help keep costs as low as possible.

Patient Participation

While protocol complexities increase the likelihood patients may drop out, a CTMS can work wonders to keep them informed on every stage of the trial. Visits can be scheduled, patients can be paid more quickly and you can even send them messages that keep them informed as soon as possible on any changes in the trial.


If your CTMS allows your research partners to more easily integrate with you, then the whole research process is at an advantage because protocol amendments can be distributed to everyone easily. What’s more, your partners can send necessary information to everyone else through the CTMS that facilitates faster adoption of a protocol amendment, which mitigates losses of both productivity and money.

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