Click here for: Full article in German
Managing clinical trials is a time-critical, resource-intensive and highly challenging organizational task. The input of a number of teams, often from different companies and countries, needs to be managed and timed effectively and efficiently. Activities in a range of disciplines including pharmaceutical production, logistics, laboratory work, submissions to regulatory authorities, on-site clinical conduct and study monitoring have to be controlled. Increasingly tough regulatory requirements and the advance of digitalization are producing more and more data that has to be documented, reviewed and evaluated to make the best decisions. A Clinical Trial Management System (CTMS) based on a low-code system could be the solution, especially for medium-sized pharmaceutical, biotech and medical device companies.
The use of IT systems based on separate applications for complex projects like clinical trials inevitably produces data silos that are not practicable and limit manageability. Moreover, clinical trial sponsors and Contract Research Organizations (CROs) risk losing data and breaching data security requirements or Good Clinical Practice (GCP) standards by using spreadsheets and local data storage. High IT standards including central storage, regular backup and user access management are mandatory in a research field that involves handling patient data and has implications for people’s health.
A growing number of CTMS have been launched by software companies in recent years. These systems have a host of functionalities central to clinical trial management, helping to keep track, create reports and identify time-critical paths. Key features include a customizable web page, sophisticated access control mechanisms, accessibility for new programmers and the possibility to connect to other systems. Most of these solutions are based on SaaS so are easy to use and highly convenient. On the other hand, the flexibility to customize applications in response to specific customer needs is limited. Clinical projects often differ in terms of geographic location, how tasks are split between different stakeholders, or whether a medical device or pharmaceutical study is involved. Limited adaptability could therefore be a disadvantage for the user. Also, the costs attached to these solutions are quite high and, for CROs, might not always be transferable to the sponsor of a study.
Mid-sized companies usually don’t think about programming their own CTMS solution. Developing source code from scratch indeed requires a dedicated team of programmers and high financial and time input. An alternative could be the development of a customized CTMS solution based on a low-code system. Such systems significantly reduce the development time needed, since they are accessible and usable for most levels of technical skills because most of the programming work is done automatically. The standardized toolkit used in these systems facilitates consistent quality and usability for programmers and users alike. Elements can be drag-and-dropped into spaces on the webpage and configured to satisfy all needs for the company and the customer, with the configuration including aspects such as appearance, visibility and function. Data for these systems is usually stored securely in the background using modern on-premise technologies or cloud solutions.
SSS has developed a CTMS of its own with a low-code platform that is growing all the time as new applications are added. Called accSIS, the company’s own system is an integral part of corporate IT strategy and designed to manage multinational trials with several subcontractors. What’s more, any special preferences sponsors may have can be implemented within a few weeks or even days.