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International Clinical Trials

Trial Management from the Cloud

Current studies show that small- and medium-sized CROs and pharmaceutical companies are open to a software-as-a-service (SaaS) model-based business approach. Cloud-based software is seen as an attractive alternative to stationary software for clinical trial management as Jan Nielsen at BSI Business Systems Integration AG explains

Everyone is talking about the Cloud in general, and specifically about SaaS. Cloud computing is a term used today to describe the process of accessing services over the internet. The service obtained, as well as the corresponding data, are not stored on the user’s computer, but at an external data centre. The service, such as email, is used with an ordinary internet browser as if it was a ‘normal’ application on the user’s own computer. With rapid internet connections available anywhere, the location of the actual computer on which the application runs is irrelevant.


When it comes to Cloud applications, SaaS is a special case. It involves the outsourcing of entire software environments, such as integrated ERP solutions or MS Office applications, to the Cloud and then allowing them to be used through an internet browser. The advantages of SaaS are obvious: flexibility; comparably lower investments in infrastructure; and software licenses. Nevertheless, companies are approaching their SaaS projects in very different ways. A recent study published by analysts Pierre Audoin Consultants describes the scepticism German, Austrian and Swiss companies hold for SaaS; the study shows that IT application user companies in the DACH region (Germany, Austria and Switzerland) prefer to obtain their software solutions through the classic license model and rarely use SaaS (1).

Those surveyed indicated that they prefer to avoid placing business-crucial applications and sensitive data in the hands of strangers. SaaS solutions are considered to be too risky in terms of data security, and data misuse is a major worry. The availability of a cloud application is also viewed sceptically by IT managers.

Another Gartner study compared countries in the DACH region, which Gartner counts within the western European region, with those in northern Europe, including the UK, Ireland, the Netherlands and Scandinavia (2). The northern nations are fundamentally receptive towards SaaS. “This is due to a culturally open outlook towards technology adoption, and a well-established and generally good internet infrastructure within these countries”, explains Sharon Mertz, Research Director at Gartner.

 A third international study conducted by Gartner broke the topic of SaaS down by sector and revealed a more fragmented picture (3). Here, too, there is a clear difference regarding the attitude towards software from the web and the willingness to use it in the future. Companies surveyed from the healthcare sector – among which Gartner also counts R&D life science companies – currently fall into the group with the highest level of SaaS-based, vertical-specific software solutions already deployed. Also, healthcare ranked as the top industry where the respondents were planning to use SaaS in the future.


This trend for SaaS uptake is confirmed by Pierre Audoin Consultants (PAC). Based on a study of software usage among small- and medium-sized CROs and pharmaceutical companies, they conducted supported interviews with department heads and managers. “These enterprises are astonishingly open for software offered through a service model,” reported Stefanie Naujoks, who is in charge of the study at PAC (4). The analysts have an explanation for this trend. In particular, small- and mediumsized CROs that conduct studies on behalf of pharmaceutical companies, along with smaller pharmaceutical companies themselves, are subject to financial and time pressures for which they, at the same time, only have limited personnel resources at hand. It is therefore little wonder that investments in suitable software solutions are not their top priority, to which Naujoks adds: “In addition to the pure cost factor, there is frequently no one that has the time to handle the selection of software, not to mention the calculation of the potential gain in efficiency. The purchase of standard software in a service model appears here to be a viable alternative to a large-scale, individual project.”


Gudrun Skiba has been active in the life science and software industry for more than 20 years. She sold software for life science companies for a number of years and is now active as a freelance consultant. Skiba explained: “The number of studies being conducted with electronic data capture (EDC) has risen rapidly in recent years. At the same time, using software for improved planning and real-time monitoring of clinical studies – a clinical trial management system (CTMS) – remains a major hurdle for many CROs and pharmaceutical companies.” Studies can be planned, monitored and evaluated throughout their entire life cycle with a clinical trial management system: from transnational studies and cost planning as well as study and cost control; to the logistics of the test substances; the capturing and auditing of monitor visit reports; the planning and controlling of patient visits on to the evaluation; and tracking of the billing of investigators and the preparation of the data for entry at the authorities. Skiba continued, “Some companies have depicted essential CTMS features using software, often as in-house developments and upgrades to existing EDC systems. However, in many places, the planning and control of the course of the study are still handled with manually created Excel tables, as well as on paper and with fax – which is rather astonishing in a fi eld so fraught with risk where data quality is essential.”

Skiba views the use of these software solutions as a SaaS model to be a good alternative to stationary software in the CTMS fi eld. “Just like ERP software, these solutions can be rented at a monthly rate per user to provide standard CTMS features. No local installation is needed; the application can be used from anywhere through an internet browser. Data storage and backup is also usually included in such a package.” Adaptations, such as the depiction of special authorisations or access options for third parties, can generally be added. However, Naujoks advises user companies not to blindly depend on SaaS: “Even if it may represent an interesting alternative, especially for smaller- and medium-sized CROs and pharmaceutical companies to depict clinical trial management with software from the Cloud, I see two factors that are decisive for the further penetration and acceptance of this topic. On the one hand, this involves the further clarifi cation of advantages of SaaS to potential users and the resolution of legal concerns, such as the data protection issue. On the other hand, establishing trusting and solid cooperation with a suitable software vendor or service provider is of central importance.”

Note: The complete PAC study on the use of software in the clinical trials fi eld shall appear in the fi rst quarter of 2012. The study was assigned by BSI.


  1. Pierre Audoin Consultants, User Survey 2011 – Software Usage and Investments by IT Users in the DACH Region, 2011, https://www.paconline. com/pac/pac/live/pac_world/global/press_corner/press_releases/index.html?lenya.usecase=show-rapport&document=pac_sitsi_reports/press_release/PR_PAC_ICT_User_Survey_Oct11&xsl=press_release
  2. Mertz SA, Eschinger C, Eid T, Dharmasthira Y, Pang C, Wurster LF, Ebina T and Swinehart HH, Forecast: Software as a Service, All Regions, 2010- 2015, 2011,
  3. Mertz SA and Anderson RP, User Survey Analysis: Software as a Service, Enterprise Application and Vertical Software Markets, Worldwide, 2011,
  4. Pierre Audoin Consultants, Software Usage within Clinical Trials, to be published in Q1/2012

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Jan Nielsen is Senior Project Manager at BSI Business Systems Integration AG, the Swiss software manufacturer of the Clinical Trial Management Solution BSI CTMS. Jan has a long track record in leading large software projects with clients such as Actelion and ALK Abello. He holds a degree in Electrical Engineering from the Technical University of Copenhagen as well as a degree in Business and Engineering from the University of St Gallen. Email:
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