The benefits of clinical trial management software confirmed by a whitepaper by PAC and BSI

Risk minimization for pharmaceutical companies and CROs of all sizes

Commissioned by BSI Business Systems Integration AG (BSI), Pierre Audoin Consultants (PAC) investigated the challenges in clinical trial management in Europe, in a trend survey conducted in October to December 2011. The results showed that the added value of dedicated software, so-called clinical trial management software (CTMS), is well known among pharmaceutical companies, both large and small, as well as among CROs. These value adding aspects include efficient, simple and error-free data entry using process-controlled workflows. Nevertheless, CTMS solutions tend to be used among the larger pharmaceutical companies and CROs, while smaller companies use MS Office products. In addition to technical factors such as the software’s user-friendliness and flexibility, vendors must also be able to offer fundamental industry know-how in order for CTMS to become broadly established.

While clinical trial management plays a key role in the development of new products, the trend analysis conducted by the market analysis and consulting firm, PAC, showed that in most cases processes that are unstructured and offer insufficient transparency endanger the smooth execution of clinical trials or the necessary regulatory approval.

The challenges: Little transparency, big risks
The analysis revealed an array of challenges faced in clinical trial management, which must be overcome by European CROs and pharmaceutical companies.

  • Obtaining regulatory approvals;
  • Selection and management of clinical trial sites: particularly hampered by low motivation and the poor quality of work provided by investigators;
  • Project management: Lacking tools for the systematic planning of the required project steps and for resource management;
  • Project performance and project controlling: lacking transparency about the trial procedure and costs;
  • Time management: Unforeseen delays, especially for larger, multinational trials;
  • Reporting: particularly among CROs – must provide immediate reports to the sponsor, heterogeneous requirements, depending on the study and customer.

“The experts I talked to mentioned that these factors complicate their daily working routines, but, nevertheless, that this is part of the daily aggravation”, reported Stefanie Naujoks, a PAC analyst and author of the study.

CTMS: Clear benefits, but limited dissemination
The interviews made it clear that these challenges are primarily confronted by large pharmaceutical companies and CROs with dedicated CTMS software. Small companies tend to use MS Office products, such as Excel and Gantt charts, for project and time management, while some also use MS Project. They continue to work on paper in many places and then transfer the data to electronic forms. The situation is similar when it comes to project controlling and reporting.

Despite its limited dissemination and usage, the study participants unanimously agreed that special CTMS software offered benefits. Important comments included:

  • Process management with guidelines facilitates the timely entering of data as well as data quality.
  • Text modules and prefabricated templates that are automatically filled in with data simplify and accelerate data entry and reporting.
  • Ready-made reports, which can be created with the push of a button, simplify, accelerate and ensure the weekly accountability.
  • Risks in the course of the project, such as adverse events, an insufficient number of patients at a trial site or commercial risks, such as exceeding the cost budget, are visible at all times.
  • The targeted motivation of investigators with transparent presentation of statistics can improve collaboration with the trial sites.

Create acceptance through simplicity, flexibility and industry know-how
Many interview partners mentioned the presumption that CTMS solutions will only become more popular if the currently low acceptance of them among users is increased. “For example, two of the people I interviewed mentioned the extra work created for the monitors as result of the data entry. This extra work is a real motivation killer,” stated Stefanie Naujoks.

Decisive criteria for the widespread acceptance of CTMS software thus include the technical requirements and particularly hygienic factors pertaining to any software: user-friendliness, good search functionalities, suitable interfaces and flexibility. “To attain acceptance among users, technical functions, such as comprehensive process managements or essential key figures and reports at the press of a button, are essential. A CTMS, in our view, must also be particularly very easy to operate and flexibly adaptable to the respective clinical trial requirements. A good vendor must ensure this with its software and, moreover, offer fundamental industry know-how”, summarized Stefanie Naujoks.

Openness towards SaaS
Smaller CROs were especially very open towards Web-based software – keyword: Software-as-a-Service. “That surprised me, because our user surveys showed that companies currently tend to purchase their software solutions in a classic license model. Despite the advantages of SaaS, skepticism predominates among many companies. However, particularly smaller CROs indicated in our survey that they viewed Software-as-a-Service as a viable alternative to large-scale individual projects," reported Stefanie Naujoks.

For Jan Nielsen, Project Manager at BSI and an expert for the life sciences industry, these represent important findings that will be helpful for the further development of CTMS. “The study results help us to better understand why, despite immense risks and uncertainties, specific software is only used in a few places and can react with the proper functions, flexibility and knowledge."

The study can be downloaded at: (English) (German)

About BSI
We develop software at the interface to the customer. BSI CRM is the leading Swiss solution for professional customer service. BSI Contract 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, die Schweizerische Post, Sika, Swiss Life, Tamedia, Versicherungskammer Bayern and other market leaders all rely on BSI products. We are specialized in system integration, software development, consultation and support services. All BSI products are based on Eclipse Scout, an open, modern framework for service-oriented business applications. Based on Java/Eclipse, software from BSI can be easily integrated into any IT environment.

About Pierre Audoin Consultants

From strategy to execution, PAC delivers focused and objective responses to the growth challenges of Information and Communication Technology (ICT) players.
Founded in 1976, PAC is a privately held research & consulting firm for the software and ICT services market. PAC helps ICT vendors to optimize their strategies by providing quantitative and qualitative market analysis as well as operational and strategic consulting. We advise CIOs and financial investors in evaluating ICT vendors and solutions and support their investment decisions. Public institutions and organizations also rely on our key analyses to develop and shape their ICT policies.
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