EDC implementation at Lundbeck Mike Bartlett System Project Manager

1. H. Lundbeck A/S EDC implementation at LundbeckMike BartlettSystem Project Manager PSDM, EDC workshop 9th February, 2006

2. Lundbeck:Specialists in Psychiatry - Pioneers in Neurology CNS Specialist Pharmaceutical Company Founded in 1927 HQ Copenhagen, Denmark Sales and Marketing / Partners Worldwide Main Therapeutic Areas Depression, Schizophrenia, Alzheimer�s Disease, Parkinson�s Disease, Insomnia

3. Early EDC Experiences Monitors entering data using laptops2400 pt, 17 countries in Europe, local labs, 1998-2000 Part of trial, Germany sites3 investigators and 3 monitors entering data, 2001 DATAFAX PMS study19 countries in Europe, 2002-2005 Electronic diary1200pt, 19 countries in Europe, 2003-2005 Electronic CRF75 pt in UK, 2003-2004

4. End 2004:Lundbeck EDC Strategy

5. Lundbeck EDC Strategy To be driven by the stakeholders Not just one department Own the knowledge EDC is a strategic competence EDC to be introduced stepwise Procedures to be revised and adjusted By 2007 conduct all phase 2-3 studies using eCRFs

6. Lundbeck EDC Strategy Web-based, direct data capture ? eSource, hosted by Lundbeck EDC-specific tasks in a study to be coordinated by an EDC Coordinator Establish an EDC Team Develop EDCC role Work on EDC specific procedures

7. EDC TeamA Cross-departmental function PROs Cross-departmental commitment Widens the procedure optics Helps target communication CONs Un-clear who is (or should be) in charge Lengthy �democratic� discussions

8. Stepwise scale-up Why? Time to involve key-personnel in defining new procedures Time to get education plans in place Time to mental adjustment and acceptance Can be undertaken as an in-house enterprise Fall-back to paper exists as a safety net However� This can seem less determined and allow resistance to grow

9. Learning Curve

10. A few challenges �

11. Expect the Unexpected,The Oops Factor Discovered that site staff did not speak English at the site training The site-rooms other than those we had checked for connectivity were used Travelled hundreds of kilometres to perform a technical preparation at a site to find that it was closed that day

12. A few more unexpected events� Virus attack hit us during a training visit and left one site un-connected for 2 weeks Major power-cut in DK disconnected all sites for 1 day + ruined an installation visit The 00-800 Helpdesk number was blocked by hospital switchboard

13. And a few more� Primary contact for cable installation at site was on holiday for over a month Local road works prevented installation of cables Connectivity tests and training were performed late afternoon. When site went �live�, day-time performance was sloooow

14. How can we face the Unknown ? Planning, Planning, Planning! Systematic walk-through of current SOPs in the workflow From study start to study closure This is a cross-disciplinary exercise (Invite your regulatory dept) Think �what if�� Top priority: keep the sites happy Investigator Survey: identify concerns

15. Reduce the �Ooops-factor� Un-expected events do happen Maintain a catalogue of Lessons Learnt use it in planning your next study

16. EDC Dialogue with the Sites Feasibility Study Equipment Using the Computer in front of the Patient Pre Trial Visit General Information about EDC Technical Qualification of Site Midway Evaluation User friendliness of Screens and Edit-checks

17. Training Concept

18. A Caring Site Approach is Vital

19. Feedback from the sites ��Love it �Easy from point of view of storage � User friendly �Easier from a CRF confidentiality point of view � Like the availability of back-up worksheets�� The laptop has been less of an intrusion into the doctor/patient/carer interface than originally thought � even less so than when writing information into the clinic notes � this has come as a surprise� �Very user friendly and easy to navigate around� �Not afraid to call Helpdesk in resolving problems�

20. The Change Management Challenge 12 new/adjusted procedures Input to SOP-revision Role changes Communication Plan Identify target groups Road Shows, open dialog EDC-days, web-site, meetings

21. Resistance Management, Day 0

22. Address Fears & Worries Redundancy Nerd Technicality Delays in Trial Start Intrusive Element for Doctor/Patient Loss of Scientifically Important Sites Loss of Data Loss of Territory (power & knowledge) Technical Problems at Site

23. Open and Hidden Resistance Not sharing important information �Nobody asked me ...� Duplicating Work Efforts �I will make my own�� Finding pre-texts for not doing the job �This is against GCP� Hostility �We don�t need you to�� Challenging the authority �My boss has never told me to��

24. Risk Mitigation Plans, Day 1+ Plan A: Prophylactic Plan B: Curative We see Resistance to Change as a risk Top-priority in our Risk Assessment Plan A = Targeted Information

25. Our current eCRF Challenges Get the eCRF ready in time Heavy front loading of resources Patient Self Rating Scales are still paper Phamaco-economic studies with country specific page variations Cross-therapeutic studies Who is responsible for which pages Does the same split apply for ALL sites?

26. Our current eCRF Challenges How to deal with negative sites � or sites that �fail� technical qualification? Will there be web-connectivity in all the �Lundbeck-Geography�? Studies with visits in Patient�s home Studies involving other eEquipment (cognitive test systems) fear of techno-overload

27. Our current eCRF Challenges eSource: How much paper do sites REALLY use? Does the computer disturb the patient-doctor relationship? Is there a safe sponsor-hosting model? Maintain the right learning curve: not too steep, not too flat Select the best-next-eCRF-study

28. What we consider to identify eCRF candidates Appropriate planning period Interval between protocol synopsis and FPFV Site Routine with eCRF Number of patients per site & Visit interval Recruitment difficulties? Logistics Number of sites, countries, time zones Number of local languages Site type (GP, Hospital, Specialist) Internet connectivity

29. Learn from Others,Share the wealth Conferences Listen and learn Present your successes and failures Meetings and Committees DIA, eClinical SIAC eClinical Forum

30. eClinical Forum An open, confidential exchange of experience and ideas Pharma, CROs and vendors in constructive dialog addressing current and future �hot topics� Valuable surveys about EDC and eClinical Informal and great fun Next meeting � Brussels, March 2006

31. Where Next ? Continuing implementation of strategy Convinced that using IT can be a driver for change Commenced work on eClinical Strategy To be presented to management Q3 2006

32. H. Lundbeck A/S Thank you for your attentionAny Questions ?