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EDC implementation at Lundbeck Mike Bartlett System Project Manager

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Specialists in Psychiatry - Pioneers in Neurology. CNS Specialist Pharmaceutical Company ... 2400 pt, 17 countries in Europe, local labs, 1998-2000. Part of ... – PowerPoint PPT presentation

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Title: EDC implementation at Lundbeck Mike Bartlett System Project Manager


1
EDC implementation at LundbeckMike
BartlettSystem Project Manager
  • PSDM, EDC workshop
  • 9th February, 2006

2
LundbeckSpecialists 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, Alzheimers Disease,
    Parkinsons 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 2004Lundbeck EDC Strategy
  • Definition of EDC
  • How much EDC?
  • Scale-up strategy
  • Impact on job-roles
  • Costs Benefits
  • Software 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
  • Integrated SAE-reporting
  • eTMF

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
3-Step Training Program for CRAs
  • Before Pre Trial Visit
  • Between PTV and Investigator Meeting
  • Close to Investigator Meeting

Site Staff trained on site by their CRA
18
A Caring Site Approach is Vital
Everyone should be prepared for a little
hardship But not the Site Staff!
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
  • CRAs
  • Affiliates
  • Data Managers
  • Management
  • Clinical QA
  • IT
  • Facts about
  • Job-Change
  • Wins
  • Losses
  • Fears/Myths?
  • Main Concern?
  • Information
  • Package per
  • Target group
  • Road shows
  • Slide-kit
  • Dept Meetings
  • News Letter
  • Web-Page

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 dont 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 Patients 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
Thank you for your attentionAny Questions ?
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