How a CTMS Can Optimize Country and Regulatory Clinical Trial Planning

As the scope and complexity of clinical study requirements continue to increase, study implementation costs also rise, and the need to efficiently manage global studies is a necessity. Many clinical trial sites are now based outside the Sponsor’s home country. CRO vendors often support a resource model of regional or home-based team members. These global study site and team member locations create inherent logistical issues for both the Sponsor and managing vendors such as CROs.

Language barriers, communications, infrastructure and global processes are common challenges for Sponsors and global teams engaging in global clinical trials. With global study expansion, Sponsors must to take on these challenges due to a need to meet enrollment requirements, resource or budget limitations. Furthermore, as the list of participating countries expands based on perceived cost savings or quick agency approval timelines, study teams often find that the oversight and logistical hurdles are critical aspects to manage.

With global trials, the end goal is to take advantage of the benefits of a vast subject population, but minimize or eliminate the constraints that create additional costs, or time lags in the process. As trial sites expand globally, the need for efficient communication, built in repositories, and real time reporting tools becomes a necessity. A web-based CTMS can alleviate many of these issues and reduce the costs, headaches and time lags associated with running studies from sites in foreign countries.

Paper-based management tools applied to global study sites quickly reach their limits. Problems with version control, document corruption or size limits, redundancy of data and manual data entry, as well as potential compliance and validation issues all create the potential to derail an entire regulatory submission. A web-based CTMS with common clinical, regulatory and project management information integration allows information to be globally shared within a single centralized location, accessible from any web-based computer or mobile device.

Agency Submission Planning

Global studies require dedicated individuals who prepare submissions and communicate with regulatory agencies in each country. The ability to obtain on-time individual country approvals becomes critical to the success of a global program, especially seasonal study indications. This topic is discussed in more detail in the following article.

A web-based CTMS can be a very useful submission planning tool when global regulatory team members are faced with a long list of countries that the clinical team wishes to consider for study participation. Having the ability to identify and share recent trends in agency feedback and approval timelines, track communications across agencies, and share commonly requested items such as translations can go a long way to help the planning and workflow activities with regulatory team members and country managers.

Anticipating Workflows and Language Barriers

A web-based CTMS fosters collaboration between Sponsors and CROs across global study teams. Miscommunications can be mitigated when team members have the information they need, when they need it, and in a layout and language they can understand. Team members will find that information that is well-organized and intuitively displayed will facilitate teamwork and effective solutions to common study challenges. As Sponsors and CROs recognize the benefits of a web-based CTMS, they become more inclined to consider the improvements that can be made within their infrastructure, resourcing, and processes, especially with the low cost to integrate a web-based CTMS over the more traditional (and often prohibitively expensive) enterprise, licensed model.

Benefits to the CRO & the Sponsor

In addition to efficiencies gained in country and regulatory planning and global team member workflow activities, CROs and Sponsors will find that a web-based CTMS supports upward reporting of global activities. With built in document repositories for study, site and departmental efforts as well as standard import/export and reporting tools, information can be easily manipulated to meet the needs of your extended team. Team members no longer have to rely on email or shared document platforms such as sharepoint, where version control, user access restrictions, and validation are issues of concern or require additional IT assistance to meet your day-to-day needs.

Bottom Line: Using a web-based CTMS will let the Sponsor and CRO vendors manage global studies effectively by mapping country activities and regulatory milestones, sharing information in a collaborative, easy to understand layout, and efficiently managing the critical tasks associated with global site and resource teams. The end result will show that subjects are recruited quickly across the globe, the study is conducted more effectively and consistently across countries, and the costs are reduced through effective collaborative teamwork.