Summer 2005
ACDM Lab SIG Spring Meeting
The Laboratory Data Special Interest Group (SIG) had its spring meeting at Pivotal Labs in York. The meeting was very well attended by a number of ACDM members with backgrounds ranging from Pharma companies, CRO, Central Labs and even a Laboratory Information Management System developer!
The main topics covered at the meeting were:
Handling Global Laboratory Data
A good Lab Data Transfer Specification
Central Laboratory Tour
The following presentations were given:
The ACDM Lab SIG – History, Achievements, Future Goals.
Sam Singh SIG Chair.
A brief overview was presented, outlining how this SIG had evolved from being a Working Party to now an active SIG. A list of previous meetings along with the main topics discussed was presented.
Global Laboratory Data Management – the problems.
Noel Redden, Roche.
Noel gave a very good presentation, covering:
Why the Pharma industry requires laboratory data and how they go about collecting it.
Using laboratory ranges and units
Problem areas – computer systems, central labs, local labs, sample handling and global challenges
Break out session – What we need is a good data transfer specification!
Attendees were split into two groups and asked to discuss/debate the contents of a laboratory data transfer specification/ agreement.
Global Data Management – A Central Lab’s perspective.
Kristine Kuryla ACM Central Laboratory Rochester USA.
Kris gave a very energetic viewpoint from the US on how a central laboratory manages a Global trial, in particular laboratory data issues and the challenges of managing several labs around the world.
How is laboratory data generated?
Christopher Ellis, Head of Global Project Management Pivotal Labs.
Chris presented an overview on how a central laboratory generates the data, from all the documentation that has to be prepared through to the different reporting methods used to report the data to the investigator and the client.
Tour of a Central Laboratory Facility
All attendees were given the opportunity to follow the full cycle a blood sample takes once it arrives at a typical central laboratory; from sample reception, sample entry onto LIMS database, passing through the various analysers and then finally reporting.
Our next meeting will be in October 2005 and the agenda items will be:
Lab EDC system considerations
X-ray data
Far East Central Laboratories.
If any member would like to join our SIG or requires any additional information please do not hesitate to contact me. We look forward to welcoming new/old members to our meetings! Sam Singh (01904 699405)
Sam Singh
Chairperson, ACDM Lab SIG