October 2004
Managing and Implementing New Systems in a Global Environment
My name is Sharon Ainley and I am currently working as Team Leader, Technical Service Group for Covance CRU, a world wide CRO. We have just undergone the process of adopting a global data management system (Oracle Clinical) throughout Covance incorporating Phases I through to Phase IV at all our sites.
The remit was to adopt this system globally, harmonising processes so that we can offer full data management services through all phases and sites, with the ultimate vision of having a fully aligned process throughout the organisation. Sounds simple enough, but with the obvious difficulties of working in different sites and time zones, then add in different processes, hardware and software, job roles between sites, and requirements of small Phase I studies vs. huge Phase III studies and the problems increase dramatically.
A full time devoted global project manager was assigned to the project, with local project managers and staff assigned at each business unit forming global sub teams, who were able to dedicate time to the project. Communication between everyone needed to be carefully handled to ensure that those working outside the main Princeton site were kept fully in the loop. Representatives from all the sites were involved at all stages of the process to ensure that all requirements were taken into consideration. At times the needs differed immensely, speaking from a Phase I perspective, our key requirements were reusability and speed of use in order to meet the stringent client deadlines we face on a daily basis – we do not always have the luxury of time afforded to later phase studies.
Some of the key factors that needed consideration were:
The technical aspects of the project needed to ensure that the system could be accessed by everyone, regardless of location and hardware, within an acceptable response time
The system could handle the differing types of data needed for clinical trials, and that this data could be entered, loaded and extracted from the system regardless of location
The system and processes would be beneficial to all sites.
As this was a global application some of its functionalities had to be agreed upon by all sites as local customisation is not always an option.
Careful planning needed to be done both on a global level in terms of ensuring the system was fully validated with key staff at each site fully trained.
The processes and documentation including global SOPs and working instructions were agreed and local sites were all ready to adopt the system.
Training material was generated in order to train all staff.
During discussions with the different study phase personnel to try to align processes it was identified that a face-to-face meeting was needed, this was done following initial training in the system. The groups were split into specialised areas e.g. labs, coding, validation procedures, study set-up etc so that the processes could be identified and discussed. This was a great opportunity to assess current processes at all sites and take them forward into the new system or adopt totally new processes – luckily everyone involved was really open to new ideas. The final processes were often a mixture of the best aspects from all the processes, whilst taking into consideration individual phase requirements. The overall finding was that despite the differences we could all work to the same overriding processes.
Although the processes were agreed they needed to be tested. This was done in the form of a pilot study comprising of each site setting up and running a short dummy study following the new processes. Some of the processes agreed were always to remain global, whilst others would be more local, and these had to be tested in the remote locations where the final data management was to be run.
This was done in conjunction with functional testing and user acceptance testing. Although the functional testing was done centrally and consisted of 100's of test scripts being performed the user acceptance testing needed to be performed at the local sites and this comprised of a subset of the original functional tests. A global administrator was assigned to oversee the testing and who would be responsible for deciding the outcome of the tests that did not produce a direct PASS. Many of the errors were documentation, but some did require further investigation – all of these though did require an error report as these would form part of the final validation documentation.
Therefore, in order to gain confidence in the system and processes, and to provide full evidence of the system testing, Covance adopted the process of performing local pilot studies, to back up the extensive validation testing. In addition to global processes, training needed to be considered. A global sub team was set-up to write global training material to ensure consistency throughout Covance and to ensure that everyone adhered to the new working practices.
Locally we had to carefully look ahead to the imminent implementation, which for Leeds, would be a totally new way of working. We were constantly trying to keep people informed of the progress, thinking ahead to how processes will change, not only in the data management department, but what effect this would also have on other departments that use the data. Frustration tends to set in where people feel they are not fully informed, and this is something that we tried to avoid.
So where are we now... the system is up and running and being used by all sites. A global steering committee meets monthly to ensure communication between all sites and to discuss any issues that arise. The global sub teams are still in place and meet regularly to discuss potential changes in processes and best practices raised via local site meetings. We are always working toward improvement both in our knowledge of the system and the processes we as a company have adopted.
Overall, we learnt that careful planning and communication were critical to the success of the implementation. Organisation and flexibility were also key factors to managing and resourcing the huge project.
Sharon Ainley, Team Leader, Technical Service Group
Covance CRU, Leeds UK