Today, 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 CTMS 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 applications and bring that preconceived mindset into working with new system.
The central position of the CTMS 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.
Contact USDM today to discover ways in which our team of experts can help you effectively develop and validate your clinical trial management system, electronic submissions processes and pharmacovigilence system to ensure regulatory compliance, so you can be confident your company is protecting its patients, study participants and reputation.
IT departments in the life science industries are constantly facing tremendous business challenges such as higher costs, lower budgets, higher demand ...