Clinical Trial Management Systems—A Decision-supporting Engine for the Future Figure 1: CTMS Business Processes Project intelligence Investigator payments


Site feasibility and selection


Study startup and initiation


Subject recruitment Interim monitoring Study closedown


Streamlining Study Activities


The function of a CTMS solution is to provide the tools to optimize the management of the clinical study process. Study start-up activities, such as site identification, initiation visits, and collection of all the necessary regulatory documents, can be a critical bottleneck that results in delays in the overall study timelines. Early deployment of CTMS within the process can help improve this important aspect. CTMS investigator databases can provide information that expedites suitable site identification, such as relevant experience and facilities, and the past performance of a potential site. Once a study is running, CTMS can assist users to keep track of all the relevant regulatory documents and provide a strong snapshot of progress in terms of site activation. The ability to track this information ensures that any potential delays can be identified quickly and addressed.


The CTMS can also facilitate site-recruitment goals. Difficulties in enrolling subjects for a trial can have a huge impact on the overall development program. By providing constant visibility into recruitment status and trial enrollment, the CTMS allows the clinical team to intervene early if a potential for enrollment delay is identified.


Every study has its own unique design. Accordingly, customization of document templates that address study-specific design elements within the CTMS allows clinical users the flexibility in designing the study without having to support complicated application customization, which can have a negative impact on study start-up schedules. Additionally, this process maintains standardization across key elements of study management. Users are able to use the same templates within the same study program.


A CTMS also provides visibility into all ongoing study activities and thus facilitates the ongoing management of the study and ensures that projects remain on track. In general, the CTMS enables tracking of information at the study, region, or site level to allow maximum visibility and flexibility. With the help of a CTMS, users can develop targeted monitoring strategies that will help reduce cost and timelines by efficiently scheduling monitoring visits based on enrollment and completed visits. A CTMS can also help track adherence to study milestones, trigger investigator payments, create and track monitoring reports, maintain contact lists, and also track correspondence with each site within the application.


Monitoring reports are one of the key operational and regulatory components and deliverables of every study. A CTMS solution can provide the ability to automatically generate monitoring reports from the information gathered during monitoring visits. The ability to synchronize automatically data entered off-line by a traveling team


member to the central database next time the user logs in to the CTMS helps ensure that the CTMS can be used to monitor visits in any location. This important functionality means that the CTMS is a tool that can be used for the whole continuum of data during a clinical program.


A good CTMS system can also help to manage and track investigator payments accurately, an activity that is critical both to managing a strong financial performance and maintaining a good relationship with investigators and site personnel. Furthermore, the added functionality of managing (from within CTMS) specific payment schedules for each site, based on specific activities, reduces the manual effort needed to generate investigator payments.


At study close-out, the process is more efficient because study teams have been utilizing standardized tracking templates within the system throughout the study, which ensures improved collection of materials and information for final regulatory packages. The standardized process also ensures that study close-out is compliant with the company’s standard operating procedures and with federal or international regulations.


CTMS Evolution in a Changing Industry The benefits of a CTMS are very tangible in terms of realizing valuable efficiencies and cost savings. Nevertheless, the next logical evolutionary step for CTMS is to unlock the power resonant within the system to allow it to become the central intelligence engine that supports decision-making and allows sponsors and contract research organizations (CROs) to manage intelligently the growing complexities of clinical trials.


To achieve this, CTMS must become more about presenting data, driving decisions, and managing costs more actively and less about collecting data and data-entry efforts. Additionally, CTMS must leverage the tools and available data to support actionable signals and alerts. This will require support by robust analytics and forecasting capabilities. Moreover, if the CTMS is to become a ‘command and control center’ for study managers it will need to be integrated fully with the relevant upstream and downstream systems. A highly flexible data-integration engine that supports multiple standard interfaces will ensure that the CTMS data can be connected to other data sources, especially as the number and types of systems is expected to increase in the new eClinical landscape.


Importantly, many of the elements to achieve this scenario are already in place. Current CTMS have study dashboards that provide clear insight into study status and progress. Importantly, data generated during the course of a study can be stored centrally. The ability to track multiple studies in the same database plus the ability to have


THE POWER OF CTMS—INTEGRATION, INTEROPERABILITY, AND COLLABORATION 5


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