A Clinical Trial Management System, also known as CTMS, is a customisable software system used by clinical trials personnel in the biotechnology, pharmaceuticals and clinical research institutions to manage the large amounts of data generated in the conduct of a clinical trial. It maintains and manages the planning, preparation, performance, and reporting of clinical trials from project start right through to project close.

It can also be used to track, maintain and report trials from an individual site right through to multiple sites. A CTMS is also used to keep up-to-date contact information of participants and to track deadlines for regulatory approval, in addition to key milestones for tracking trial progress such First Patient In (FPI), Last Patient Out (LPI) etc.

CTMS are very helpful for large and complex trials, especially multi-centre trials. However, they are probably not necessary for small simple trials. The prinicipals and tools can of course be implemented in small and more straightforward studies, and there are really helpful organisational and project management systems which would always be benefical in managing a trial.

A CTMS has a wide range of activities that can track information for senior managers and decision makers up to site-level data. Other core information tracked and stored by a typical CTMS system includes but is not limited to the following:

- Planning and tracking core events in a clinical study,
- Study approvals (regulatory and ethics)
- Key or essential documents required prior, during and at close down of a clinical site
- Monitoring visits or patient visits at each site or sites
- Budgeting, projecting and tracking cost
- Forecasting and tracking clinical supplies

Access to CTMS and the functionality available to core personnel will depend on each company’s Standard Operating Procedure (SOP) and how the system has been customised. CTMS has a wide range of capability; but in practice this tends to be under-utilised, often due to lack of training. Many companies will often adopt a clinical trial management system to plan and track clinical studies but may be unaware of its ability to budget or track cost for trials and will often have another system to track cost.

Advantages of a CTMS
One of the advantages of a CTMS is the amount of data it can handle and its ability to consolidate this information, so that the trial manager has an overview of the data in a format that quickly informs him/her of the status of the study. This information can be used to trigger key dates automatically. For instance First Patient In tracked at site level can be rolled up to populate study FPI milestone and can be tracked against planned dates.

Another advantage is that the system can be customised by users to fit their requirements or processes.
It is also possible for users to query the database, for example to determine start-up timelines per site, the cost of clinical trials per centre/country for a particular therapeutic area, the history of enrollment patterns in sites/countries etc. This historical data obviously can be valuable when planning future trials, understanding the various start-up times in particular regions or best practices over time.

System integration
Due to the capability of a CTMS, it makes sense for external data to be integrated into the CTMS system to avoid the cumbersome data entry process and potential transcription errors associated with this process. Data integration involves the transfer of data electronically between systems, making it more rapidly available. In large multicentre randomised studies, data from external systems can be integrated into CTMS. For instance data from an Interactive Voice/Web Randomisation System (IVRS/IWRS) used to track patient recruitment or data from Patient Reported Outcomes (PROs) can be integration into the CTMS. Other external data can also be integrated into the system depending on how much data is required by clinical planners for that particular study, or what may be required to query the database for historical data.

Whereas in the past different programmes had to be written to integrate external systems into a CTMS, it is now relatively easy to apply software such as an Application Programme Interface (API) to a CTMS which should routinely update external data into CTMS systems.

CTMS via the Internet
Improved internet access means that CTMSs are now readily available to field based users, typically study monitors. Previously monitors had to download template reports for their visits, then upload these later into the main frame CTMS database. This meant that even though data is recorded electronically it may not have been available for a few days, if the monitor had a number of study visits to make. There are also technical issues that could be encountered in downloading and uploading reports which could further delay access to data. This is now being improved, in that real time data can be entered directly into the main frame systems via the internet in places where access is readily available.

Conclusion
There are numerous benefits to maintaining a CTMS system but like any other electronic tracking system, the benefit can only be realised if data is entered in a way that can easily be queried by the end users to produce the desired output. A CTMS has the capability to store a lot of information, but users need to be trained properly to benefit from the system. CTMSs can also be expensive and therefore are tpyically only used by large clinical trial organisations.

Those running small clinicals trials should still be encouraged to implement some form of simple management system that can achieve the same aim of logging the study documents, tracking enrollment, noting key dates (such as reporting to ethics committees) and tracking SOP version dates, training, and so on.

References
Rocchio, Sheila “Clinical Trial Management Systems: Here to Stay?” Applied Clinical Trials Jan 2013
Butler, Robin “Clinical Trials Management Systems - a review” Innovations in Pharmaceutical Technology Jan 2001 pg 102 - 107