BSI Business Systems Integration AG releases the Spring Release 4.2 of BSI CTMS to the market. The project management and controlling software for multinational clinical trials for pharmaceutical companies and clinical research organizations (CROs) offers three major advantages for customers: Both the configuration options and the reporting functions have been enhanced. The new upgraded Process Wizard and graphics support the designing of trials step by step. The Process Wizard lets users "click together" trials from prefabricated modules. The newly designed Recruitment Graph visualizes patient visits at the sites in a target/actual comparison. BSI CTMS 4.2 is available immediately.

Flexible customizing
"We noted many constructive improvement suggestions and requests from our customers at the first BSI CTMS user group meeting in October 2011 and have already implemented some of them in Release 4.2 of BSI CTMS,” commented Jan Nielson as Community Manager in charge of life sciences industry at BSI. Among the resulting upgrades in BSI CTMS 4.2 for administrators is that they can now make many configurations themselves, such as redefining and allocating authorization concepts or adding new fields to dialogues – all without programming skills.  

Customized reporting
The reporting functionality was also upgraded. Templates can be set up by the administrators themselves directly in MS Word using the Document Generator. Users can create documents for the Trial Master File, like the Site Contact Details or the Pre-Trial Monitoring Report with a single mouse click.

Trial design made easy
Trial design was significantly simplified in BSI CTMS 4.2. Trials can be clicked together from prefabricated modules using the Process Wizard. Graphic tools provide a better overview, such as for patient visits at the sites, which are visualized in an actual/target comparison (Recruitment Graph).

Outlook for BSI CRM 5.0
The Autumn Release of BSI CTMS 5.0 will be published in October 2012 and will contain many technical improvements that will offer users even more simplicity, flexibility and independence. According to Jan Nielsen, "among these will be the ability to change columns in reports yourself – you will able to fill in columns with new data, even linked data, or change their order. This will further improve the reporting functions in BSI CTMS.”

Background: The functions of a CTMS application
The testing of new medicines is a business-crucial process for pharmaceutical companies. Long trial durations of ten years or more, highly complex, multinational trial designs and strict regulatory requirements pose a challenge to what are often rudimentary IT infrastructures at pharmaceutical companies and CROs. Many processes are conducted on paper and in Excel and Word, instead of using a professional controlling and project management application.

BSI CTMS is easy to use and contains all the function modules needed for the planning, execution and monitoring of clinical trials. The modules can be flexibly combined and make it possible to conduct local, regional and global studies. Data from investigators, monitors and other stakeholders can also be managed and the supply of medicines and the financial figures can also be monitored. A monitor visit process guided by the Process Wizard and the automatic, adjustable visit protocol (author, time, data entry type and modification) boost efficiency and also ensure the reproducibility of trials.

The offline version of BSI CTMS makes it possible to enter data directly at the source such as at the doctor’s office. A software-as-a-service-based version of BSI CTMS provides pharmaceutical companies and CROs with a flexible and simple operating model. BSI CTMS, with its open technologies and architectural concepts, such as Eclipse, Java, and SOA, can be flexibly integrated into existing IT environments and applications.


We develop software at the interface to the customer. BSI CRM is the leading Swiss solution for professional customer service. BSI Contact supports agents in multichannel contact centers. BSI Counter is the product for clear processes at the counter and check-out stand, while BSI CTMS is for clinical studies in the pharmaceutical sector. The simplicity and versatility of our software has already convinced more than 70,000 users. ABB, ERGO Direkt Versicherungen, Lidl, M-net, PostFinance, the Swiss Post, Sika, Swiss Life, Tamedia, Versicherungskammer Bayern and other market leaders all rely on BSI products. We specialize in system integration, software development, consultation and support services. All BSI products are based on Eclipse Scout, an open, contemporary framework for service-oriented business applications. Based on Java/Eclipse, BSI software can be easily integrated into any IT environment.

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Nielsen Jan print 345 K