Propack Data strengthens leadership position in clinical field

Propack Data announces that Pharmacia has selected its Clinical Trial Management solution (PMX-CTM) to manage its clinical operations on a global basis. The roll out of the system, which is scheduled to take place throughout 2001, will involve two locations in Italy (Nerviano) and the USA (Kalamazoo). This decision reinforces Propack Data's market leadership position in the clinical field for delivering collaborative, scalable, enterprise-wide solutions.

Need — The systems in use in Nerviano and Kalamazoo included several independent systems varying in automation complexity, functionality, age, and ability to comprehensively manage and track material and formulations from bulk drug through distribution of finished product. From a business point of view, to improve its operational efficiency and streamline its business, Pharmacia needed to replace the site specific systems with one unified approach to global material management. From an IT point of view, this environment was hard to integrate, validate, maintain, and did not provide the expected functionality.

Solution — After carefully evaluating several vendors, Pharmacia chose Propack's PMX-CTM solution for the following reasons:

1. the breadth of PMX-CTM functionality that enables the automation of complete business processes on a global basis and the replacement of several existing and separate solutions;
2. the ability of PMX-CTM to meet cGMP & 21 CFR part 11 compliance requirements;
3. the modern object-oriented technology of PMX-CTM that fosters reuse & facilitates validation;
4. the ability of Propack Data to deliver solutions on a world-wide basis.

Project — Propack Data & Pharmacia have established a long-term partnership to meet the needs of Pharmacia and enhance the functionality of Propack's standard PMX-CTM software package. Challenges that must be addressed include multi-language support (to enable the management of clinical studies on a world-wide basis), just-in-time label printing, complex randomization functions (to meet changing business needs), and material tracking and reconciliation at the dispensing unit level (to improve operational efficiency and provide complete lot genealogy). The project is broken down into two phases. Phase 1 will deploy the following PMX-CTM modules: EDB (master recipe definition, study design, labeling & randomization), PALETTI (warehouse management and material handling), DISY (weighing & dispensing), and PDB (reporting). To improve efficiency and reduce the risk of errors, bar code devices will be installed. Phase 2 will focus on developing a paperless environment by deploying an Electronic Batch Record system (EBR module). In accordance to its quality management procedures, the system will be validated at Propack Data before being installed, configured and validated at the customer site. To address globalization issues, a Site-Gateway product ensures synchronization between multiple databases located in different countries. A Web-Gateway product enables Pharmacia market companies or investigators all over the world to request the preparation or shipment of clinical supplies . Phase 1 roll-out is expected to bring about 70% of expected benefits, which include reduction in cycle time, costs savings and data reporting errors. As companies strive to increase shareholder value, being able to reduce time to market or eliminate invalid clinical studies early on are very attractive propositions that translate into higher revenues and lower costs.

Standard Product — The solution to be delivered to Pharmacia forms the basis for the next release of the standard PMX-CTM software solution and is being developed with three other pharmaceutical companies. "By gathering requirements from multiple customers simultaneously, we are able to provide solutions that are tailored to our customers in a cost effective manner", said Karl Linder, CEO of Propack Data GmbH. "The synergy that results from involving many of our customers allows us to standardize the product quickly and in a way that benefits the entire pharmaceutical industry" added Christian Fortunel, President of Propack Data Corporation (U.S. subsidiary). A benefit of product standardization is to significantly reduce the total cost of ownership over the entire life of the system. During installation, the system is configured quickly using a standard package development methodology. Validation is done faster and with less risk by taking advantage of in-house testing. Maintenance costs are reduced by taking advantage of regular product releases instead of new developments.

About Propack Data — Propack Data provides pre-validated software tools to manage and improve efficiency over the entire drug development life cycle, from research and development (PMX-RDM) to clinical trials (PMX-CTM), and manufacturing and packaging (PMX-MES). Propack's PMX product line fulfills FDA/CGMP guidelines based on 21 CFR Part 11 regulations, and integrates fully with other corporate applications such as Enterprise Resource Planning systems (ERP), Document Management Systems (DMS), Decision Control Systems (DCS), and Laboratory Information Management Systems (LIMS). Propack Data's products are used by more than ten thousand users worldwide at companies such as Abbott Labs, Aventis, Glaxo Wellcome, Pfizer, Roche, Novartis, Eli Lilly, Merck AG, and Schering AG.

Propack Data's U.S. headquarters is located at 2000 Regency Parkway, Suite 375, Cary, N.C. 27511 (Tel: 1/919-465-1741). The German headquarters is located at Vincenz-Priessnitz-Strasse 1, Karlsruhe, D-76131 (Tel: 49/721-9650-6). More information about Propack Data can be found on its website: www.propack-data.com).

Source: Propack Data