CTMS ServicesToday, more and more companies are looking to clinical trial management system (CTMS) applications to streamline their clinical development operations. When selected and implemented properly, a CTMS can help users more efficiently and effectively manage multiple trials around the world.
A CTMS not only allows for the tracking of activities and results with access to real-time information, it can also eliminate the need for ad hoc systems, one-off spreadsheets, and individual approaches to trial management. In short, it can enable efficiencies that just weren’t possible before.
Implementing a CTMS is a very complex undertaking. In many cases, new CTMS applications are replacing legacy applications or informal systems developed over many years. This process requires users to unlearn the old way of working with a CTMS in addition to learning the new way. It also requires a change in attitude, since many stakeholders distrust older CTMS and bring that preconceived mindset into working with new system.
The central position of CTMS applications in the overall information cycle further complicates CTMS implementation. For example, many other systems (e.g., EDC, Safety, IVRS, CDMS) within the company (or the appropriate parts of those systems) need to be integrated with the CTMS.
Finally, the wide range of stakeholders involved in CTMS implementation makes the process even more complex. Even though study management must drive the implementation, they must collect and consider input from site management, data management, finance, contracts management, and many other areas.
To avoid rework, unnecessary effort, and general disappointment in the CTMS, those responsible for implementation must develop a sound requirements definition process that guides their efforts, identifies up front the system requirements and systematically collects feedback from the right stakeholders to ensure that their needs are met.
US Data Management (USDM) has a proven record of ensuring that our clientele’s Clinical Trials Management System (CTMS) applications collect and manage clinical data reliably, efficiently and in compliance with government regulations and industry best practices.
US Data Management (USDM) consulting professionals are experts in performing requirements definition, risk assessment, vendor selection & auditing, implementation, compliance and validation services using a best-practices approach that expedites the compliance process and minimizes costs along the way for our clients. Our professionals work closely with client representatives, software engineers and end-users to ensure that requirements (e.g., business, functional and compliance requirements among others) are properly articulated for efficient testing minimizing execution times and costs and ensuring that stakeholder and user community needs are met.
In addition to hands-on experience in one or more CTMS applications, our USDM consulting professionals have in-depth knowledge and expertise in the following:
- FDA regulations (e.g., 21 CFR Parts 11, 210, 211 and 820) relevant to CTMS
cGXP (i.e., GLP, GCP and GMP) - Development of validation documentation packages and SOPs
- Execution of validation/qualification protocols and test plans.
Examples of CTMS applications that our USDM consulting professionals have successfully validated include:
- Transenda
- PhaseForward
- ClinTrials
- TrialWorks
- Oracle Clinical
- Siebel Clinical