General Manager IST GmbH - Mannheim. 26th Annual EuroMeeting March 2014 ACV, Vienna Austria

Transcription

1 EDC-System Selection From the point of view of small to mid-size CROs Steffen König General Manager IST GmbH - Mannheim 26th Annual EuroMeeting March 2014 ACV, Vienna Austria

2 Disclaimer The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. ( DIA ), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners.

3 Relevant CRO Facts Full-Service CRO 60 Employees 5 Statisticians 3 Statistical Programmer 11 Data Managers <10 ecrf Studies/year

4 Selection Process The vendor selection process aims at providing evidence that products and/or services delivered consistently meet particular requirements: Regulatory requirements Study- / Project requirements User requirements Budget requirements

5 Selection Process What do we expect from the EDC provider?

6 Environment Phase III Sponsor A NIS Phase I Sponsor B Lab-Data Questionnaires Med. Devices Phase II Sponsor C PASS Phase IV Sponsor D PASS Device Data Med. Devices Diagn. Tests

7 Administrative Requirements Beside standard administrative and standard functional requirements: Different environments must be reflected Clear cost structure Acceptance by sponsor Priority changes should be possible Changes in reasonable period of time Support of management processes

8 Selection Process What other considerations are important?

9 Vendor Characteristics Small EDC Provider Large EDC Provider Offices 1 5 Employees > Data center Languages 2 15 No. of projects per year > 500 Helpdesk 10 hrs at working days 7/24/365

10 Vendor Characteristics Small Vendor Has the vendor the capacity to setup the planned number of projects? Has the contact person a backup Does the vendor fulfill all technical reqirements? Is the vendor able to improve the services according to your requirements? Large Vendor Is the number of projects you ve planned of interest to the vendor? Do you have the same contact person and backup for all your projects Do you need all these opportunities? Is the vendor willing to improve the services according to your requirements?

11 At vendor site: Business Continuity Disaster recovery plan Back-ups in all key positions including management Mirror site Sound financial basis Escrow-Service

12 At CRO site: Business Continuity Emergency action plan Monitoring of Vendor (Risk Management) Personnel turnover, changes in management Major changes in company policy Changes in reliability or accuracy Yearly Feedback Meeting on Management level Use ESCROW service Have a second provider in reserve

13 Selection Process Experience from a vendor selection

14 Early Experience 1 st ecrf Selection Process (2006): Presentation of system at CRO by vendor Check if system meets our requirements Check of contract and costs Installation of ecrf test-system IT Test-Environment (Server etc.) Setup on local PCs for test-users

15 Early Experience Result (User): Very flexible All requirements fulfilled High performance Easy administration Clear cost structure This is the system we want Result (Auditor): Facilities not acceptable Back-ups not acceptable Documentation not acceptable SOP system not acceptable Business continuity not acceptable

16 Lessons Learned A clearly described selection process with involvement of all relevant parties is necessary to avoid: Mismatch with project needs Non-compliance with regulatory requirements Costs for needless installation and testing Redundant activities IT conflicts (capacity, system requirements)

17 Cross Functional Responsibilities All involved departments/functions must be involved in the selection process Task Study- / Project Requirements Technical Requirements (Hardware) Technical Requirements (Software) Budget Regulatory Requirements Vendor Qualification / Audit Responsible Project Manager IT Datamanagement / Project Manager Management / Finance QA QA

18 Relevant selection factors Vendor company size fits CRO size Number of projects Vendor capacity Technical requirements User requirements Communication (one face to the customer) Budget

19 Key to Success Cooperative partnership 1 Team: Sponsor & CRO & Vendor Open communication with visions how to improve processes Continuous improvement of technical services Mutual benefits

20 EDC-System Selection From the point of view of small to mid-size CROs Thank You!