Ferring combines compliance with innovation

The technical reason was an important software update of SAS’ clinical solution (i.e. SAS® Drug Development) and the transition to a fully hosted solution at SAS.

”It is more than just new software, it is also change management. Updates can be an excellent opportunity, as we have to implement new working procedures anyhow. This change goes hand in hand with our own development as a global company. We still have most full-time employees in Danmark, but also employees in Japan, China, India, the US and other countries. That is why we now work in virtual teams across offices and development centers around the world. For that reason, we needed a system, which supports our globalization process and gives the employees access to the same information, no matter where they work. Although the data center is located in SAS’ HQ in the US, the transition to a hosted solution has ensured high performance,” Silvana Cappi says.

In addition to SAS Drug Development, the solution consists of SAS’ JMP Clinical, which is an important tool for clinical data analysis, visualization and reporting from clinical trials and Central Statistical Monitoring (also called risk-based monitoring), which also contains analyses for detecting ’strange’ data behavior and potential fraud.

”In the new version, narratives and patient profiles among others have been incorporated in order for us to get useful reports from our data and have a continuous overview of how our clinical data develops over time in a program or a study’s progress. It is important as we always have to maximize the chances of a project becoming successful, and this implies among other things that we early on are made aware of anomaly or problematic data,” Silvana Cappi explains.

This approach goes hand in hand with FDA’s initiative on risk-based monitoring. In this way, Ferring has implemented risk-based monitoring together with SAS and by use of JMP Clinical developed tools and methods, which again assist in developing the industry’s work on compliance and risk management.

At the same time as Ferring has created a shared global platform with uniform working procedures through SAS Drug Development (and soon to come JMP Clinical), the tool has also created an interest beyond the actual research work, says Silvana Cappi. At present, Ferring’s responsible persons for data management explore the possibilities for using some of the elements in the work with risk-based monitoring.

”JMP Clinical allows us to see different elements in data – are they within the normal range or is there a suspicion that someone e.g. has invented patient data or has reported data incorrectly. If one hospital has completely different reporting data compared to the other participating hospitals, then it is possible to investigate this, carry out targeted monitoring and save a great deal of time and money compared to initiating a comprehensive investigation of abnormalities,” Silvana Cappi explains.

Seize the opportunity
Silvana Cappi is very conscious that the employees at Ferring have to stay sharp and constantly challenge themselves to stay on top of the global competition. This is why she has been very pleased that SAS has supported Ferring both in establishing the right technical environment and in entering the strategic process on optimization of working procedures.

”SAS is certainly committed to this project, and this is important to me. It is not only what we have today – it is what we need in the future. This is why the investment that SAS has made in developing software etc. is an important component to me.”