Ferring Pharmaceuticals Running a virtual department through outsourcing

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1 Ferring Pharmaceuticals Running a virtual department through outsourcing Silvana Cappi

2 Running a virtual department through outsourcing the situation outsourcing strategy outsourcing models key success factors challenges and tools conclusion

3 Running a virtual department through outsourcing the situation outsourcing strategy outsourcing models key success factors challenges and tools conclusion

4 1950 Ferring founded in Malmö, Sweden 1999 Ferring International Centre 2002 R&D facilities in Copenhagen

5 the situation (internal( internal) internal resources workload full time employees 2 phase III trials full time employees 27 trials ongoing

6 Biometrics Department Executive Director Silvana Cappi Systems Administrator Joseph Philip Assistant Gunilla Nilsson Director Clinical Data Management Anders Åkesson Associate Director Statistical Programming Vacancy Director Biostatistics Egbert van der Meulen Clinical Data Manager Anders Munch Bjerg Clinical Data Manager Mette Holm Kent Statistical Programmer Karin Fleischer Steffensen Statistical Programmer Gitte Dam Jepsen Project Statistician Allan Blemings Project Statistician Bjarke Mirner Klein Clinical Data Manager Jens Langendorf Clinical Data Manger Christel McMichael Statistical Programmer Bettina Ernholt Nielsen Statistical Programmer Lars E Christensen Project Statistician Per Broberg Project Statistician Sandra Goble Statistical Programmer Parag Naithani Statistician Anders Malmberg

7 the situation (external environment) - high attrition rates

8 - complicated and lengthy process

9 - high costs taking a product to the market costs (included the cost R&D, clinical trials, failed drugs, and the cost of capital) $ 802 million dollars (2003 figures) today > 1 billion!

10 - workload difficult to predict workload Delays New activities Questions from authorities time

11 internal situation resources vs. workload external environment outsourcing high attrition rate complicated and lengthy process very expensive workload difficult to predict

12 Running a virtual department through outsourcing the situation outsourcing strategy outsourcing models key success factors challenges and tools conclusion

13 at the beginning tactical urgency!

14 outsourcing, an illustration: Workload vs. Resources workload gap FTEs Year

15 sponsors were complaining of. - vendors not delivering according to expectations - poor communication - poor responsiveness - inadequate resources (quality and/or quantity) - too much internal work required - contract organisations not pro-active (Results from survey Spring 2005)

16 vendors are complaining of. - negotiations are one-sided - micro-management - higher standards than sponsors are hold to - little trust and sharing of information - not considered part of the team (Avoca Group, 2005)

17 strategic view to outsourcing - what to outsource - what do we keep in-house - which model is the best for us - to whom

18

19 strategic outsourcing phase I studies outsourced phase II and pivotal phase III in-house in house staff focus on core activities ecrf applications outsourced partnerships with preferred providers whether in-house or outsourced: seamless!

20 core activities / responsibilities definition of standards repository databases in-depth knowledge of our products (our activities) outsourcing management

21 Running a virtual department through outsourcing the situation outsourcing strategy outsourcing models key success factors challenges and tools conclusion

22 we need a sourcing model that - is adaptable to peaks and troughs - gives access to first rate expertise - minimises risk - minimises use of internal resources - allows us to focus on core activities

23 off-shore group in India independent contractors staff augmentation

24 out-tasking tasking 2001 EDC ecrf provider - applications - data management

25 projects Biometrics activities for a clinical trial or group of trials

26 Running a virtual department through outsourcing the situation outsourcing strategy outsourcing models key success factors challenges and tools conclusion

27 key success factors choice of preferred providers - ensure regulatory compliance - ensure compatibility, good cultural match clarifying expectations - milestones - overall timelines - roles and responsibilities - define deliverables - methods, etc.

28 key success factors contracts - standard responsibility split joint vendor company teams - communication tools - face-to-face meetings

29 long-term relationships stability shared values openness

30 Running a virtual department through outsourcing the situation outsourcing strategy outsourcing models key success factors challenges and tools conclusion

31 common goals and communication

32 factors affecting communication - culture - ethnicity - generational - gender - media

33 multicultural and virtual communication cultural awareness how?

34 systems, procedures and environment exchange of info in almost real time common SOPs sharing same environment SAS Drug Development program for interchange

35 Running a virtual department through outsourcing the situation outsourcing strategy outsourcing models key success factors challenges and tools conclusion

36 conclusion successful partnerships are possible! successful teams require common goals and commitment trust and respect clear leadership empowerment good communication & tools to support it

37 Thank you! Global Biometrics 2009

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