In almost no other industry are development cycles as long as in pharmaceuticals. For a pharmaceutical company, the transparency and predictability of the development process are therefore of inestimable value. To meet the comprehensive worldwide planning and resource management requirements of the company’s pharmaceutical projects, Merck implemented a Project Integration Management System that is based on the high-end project and portfolio management solution OPX2.
In 2003 and 2004 Merck was still working with stand-alone solutions such as MS Project and doing budget planning with hundreds of Excel sheets. After extensive evaluation, Merck took the decision to introduce the high-end project management solution OPX2 in its Pharmaceutical division, where all pharmaceutical development projects are planned and monitored. Le Bihan Consulting was responsible for customising and implementation.
OPX2 is a high-end system specially designed to cater for the needs of large companies and organisations which provides integration of single and multi-project management. The open and flexibly customisable architecture of the software makes it possible to combine project and corporate organisation in a detailed matrix structure, with all company rules being precisely mapped, and to use multi-project management for group-wide capacity planning. Each OPX2 installation is customised to the requirements of a specific enterprise.
Global access
In deciding which features to include in the OPX2 installation, Merck focused on those processes that its organisation regulations stipulate for drug development. Many of these standards are derived from the strict statutory regulations to which the pharmaceutical industry is subject. The system was first used in production in summer 2004, but has since been continuously improved by Le Bihan in accordance with the requirements of Merck R&D. As Dr. Franz Werner Kluxen, Senior Manager R&D Information Systems, explains: “We currently plan and control the entire development project of a drug with OPX2, from preclinical laboratory research and development of the agent through clinical trials to market launch. OPX2 runs on servers and backup servers at the headquarters in Darmstadt. Project managers throughout the world access the system via the Intranet. Those at Merck subsidiaries in Lyon, Boston or Durham (North Carolina) profit from OPX2 through our Citrix terminal server. We really do map 100% of our development projects with this system.”
OPX2 is the leading solution for project controlling. Not only are budget figures calculated with OPX2, the actual figures for time and costs are also fed back into the system. Merck opted for SAP to collect its actual figures. The 300 OPX2 users also include a core team of 20 to 30 project planners, around 40 resource managers as well as a controlling group, human resources administration and the portfolio group. Merck uses OPX2 to plan the timeframe for development projects, the deployment of the staff and utilisation – of particular interest to line managers. Medication planning for clinical trials is likewise planned with this software. However, at Merck the planning system is called Comet and users do not access the PIMS data. The approximately 90 Comet users worldwide also conduct local trials in places such as Australia, South America, Hong Kong, Singapore or the Middle East.
Work with OPX2 is generally role-based; only power users and project managers work with OPX2 Pro. The projects created and managed under OPX2 Pro can subsequently be used for a wide variety of evaluations. Staff with the appropriate authorisations can view the published evaluations and reports on the Intranet. Global access to projects is a particular advantage of the Merck OPX2 solution. When introducing PIMS and OPX2, the company simultaneously revised its own processes and its structures for worldwide cooperation. The PIMS start-up thus went hand in hand with a worldwide consolidation of research & development processes. Le Bihan staff were generally present on site in Darmstadt during the initial phase, so that new requirements could be quickly integrated into the OPX2 implementation. In the beginning, training sessions were held by Le Bihan staff; today, even power users can be qualified by Merck itself. In addition, the in-house team is capable of handling first-level support and carrying out minor modifications to the system.
Precise planning
One of the highlights of the OPX2 installation is the Parametric Estimation Module, which is used to plan the requirements for clinical trials. Based on an extensive database of empirical values, Merck has developed a set of parameters that enables the expenditure for a trial to be precisely forecast. The person responsible for planning simply enters the previously defined parameters into OPX2 and the personnel costs for the clinical trial are calculated within a few minutes. Given that a trial can easily require one or two thousand man-days, dependable planning is of key importance. Thanks to the Parametric Estimation Module with its high degree of specificity regarding the required project resources, Merck has been able to make the planning process not only much more reliable but also far more straightforward. Today, the program controlled evaluation provided by OPX2 allows Merck to plan its requirements precisely, in detail and individually for each phase.
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OPX 2 Pharma
Consultants
Merck
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