Managing globally distributed and auditable processes
A Clinical Trials Manager in the pharmaceutical industry can spend a lot of time on planes. Hating to waste time, Francesca uses her four-hour flight back to the UK to work on the three clinical studies she's managing. Via the browser on her PDA, operating over the in-flight phone system, she connects to the Theatre back at HQ outside London. After completing security checks, she resumes her role as Manager of the Phase 3 trial for Dimoxinol and finds herself taking part in interactions with investigators in France and Belgium. Decisions made and communicated, she moves on to reviewing a proposed change to the protocol - it has been through earlier stages in the process but the Theatre knows that it now needs her approval. As soon as she decides to work on it, the Theatre assembles the necessary documents and places them on her PDA: no need to remember where things are, everything is presented to her in context. A quick scan of the change reveals a serious flaw, so she adds her reasoning and rejects it. The Theatre pushes that part of the study process on automatically by sending the rejection immediately by e-mail to the change proposer.
The Terathroxine trial in Japan has been suffering from poor patient recruitment rates - as she finds out when she switches to acting the role of its manager. So what has happened recently? The Theatre memorises everything that happens, so it's possible to look back at the conduct of any process and see who did what and when. As Trial Manager, Francesca has the necessary rights to act another role in the process - Auditor - and to browse the history so far. It's not long before she discovers that one of her investigators has been taking an inordinately long time taking part in a joint decision that sits on the critical path. Stepping out of that role and back into the Trial Manager role, she checks the background of the investigator to find that this is his first experience of this sort of trial. Time to act . . .
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Managing
globally distributed and auditable
processes