Title: EDC implementation at Lundbeck Mike Bartlett System Project Manager
1EDC implementation at LundbeckMike
BartlettSystem Project Manager
- PSDM, EDC workshop
- 9th February, 2006
2LundbeckSpecialists 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
3Early 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
4End 2004Lundbeck EDC Strategy
- Definition of EDC
- How much EDC?
- Scale-up strategy
- Impact on job-roles
- Costs Benefits
- Software Strategy
5Lundbeck 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
6Lundbeck 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
7EDC 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
8Stepwise 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
9Learning Curve
- Integrated SAE-reporting
- eTMF
10A few challenges
11Expect 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
12A 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
13And 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
14How 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
15Reduce the Ooops-factor
- Un-expected events do happen
- Maintain a catalogue of Lessons Learnt
- use it in planning your next study
16EDC 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
17Training 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
18A Caring Site Approach is Vital
Everyone should be prepared for a little
hardship But not the Site Staff!
19Feedback 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
20The 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
21Resistance 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
22Address 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
23Open 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
24Risk 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
25Our 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?
26Our 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
27Our 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
28What 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
29Learn from Others,Share the wealth
- Conferences
- Listen and learn
- Present your successes and failures
- Meetings and Committees
- DIA, eClinical SIAC
- eClinical Forum
30eClinical 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
31Where 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
32Thank you for your attentionAny Questions ?