The Safety Department of the Biotechnology company had been waiting for months for the completion of a new adverse event reporting system, but it never seemed to get beyond the 80% complete stage. The IT department asked the consultant to take over management of the project. He worked with the development staff to understand what they had and what was missing in their view. He then worked with the customer, the Safety Department, to understand what it needed in the short-term and what it would need after that.
The consultant negotiated priorities with the customer, set up a project plan for the developers, hired a technical writer for user documentation and training materials, and organized a QA effort. The first release was delivered in a month. A second release, delivered a couple of months later, cleaned up the user interface and provided additional reports for foreign regulatory agencies. A third release re-implemented the system with a new development tool and made it possible for clinical trial partners in Europe to enter the initial adverse event report instead of faxing the report for later entry. This eliminated an 8-9 hour delay affecting the timely submission of reports to European regulatory agencies.
Biotech event reporting system bogged down at the 80% stage
TAP-a-PM consultant produced results in less than one month
Consultant ensured compliance in Europe with the system delivering timely reports to the regulatory agencies
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