Contact:
Zeno Hug
Phone: +41 (0)56 484 19 59
E-Mail: zeno.hug@bsiag.ch
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Baden/Switzerland (pts027/07.12.2007/13:50) - BSI, together with Actelion Pharmaceuticals Ltd. in Basel, Switzerland, has developed new clinical trial management software (CTMS), a product for managing clinical study data. Compared to conventional solutions the new software with the name BSI CTMS is much less costly in its development and operation. Thanks to its open architecture BSI CTMS can be adapted to the specific requirements of any pharmaceutical company.
In October 2006 Actelion and BSI signed an agreement with the aim to develop and introduce a new CTMS together. Now, one year later, Actelion has put the first version of the solution into operation. The costs for development, implementation and rollout of BSI CTMS remained significantly under what CTMS software projects of this size and complexity usually cost.
Efficient data capture online and offline
BSI CTMS is equipped with all required functions for the central acquisition, capture, monitoring and analysis of clinical non-patient related data for regional or global studies. The first version of BSI CTMS is deployed worldwide at Actelion to serve 100 users at 140 sites in 26 countries. Apart from Actelion employees, external organizations have access to the system as well; the access rights are easily configured. In BSI CTMS for Actelion there are over 40 roles defined such as "Principal Investigator" or "Regional Monitor" that can be assigned by the system administrator to the various project teams and organizations. Thanks to the full offline capability of the solution, all test and audit trail data can be captured directly on site in the so-called "Site Monitoring". The audit trail is the reproducibility report on the study that needs to include all the information about the originators, time and type of the data entry or modification.
Short time to market, low total cost of ownership
Clinical trials and their audit trails are mission-critical business processes in the pharmaceutical industry. The faster a company receives approval for a newly developed drug the longer it can benefit from patent protection and the more revenue it can generate. In this respect, the efficient and secure BSI CTMS provides decisive advantages to pharmaceutical companies; it supports them in the expeditious conduct of their studies in compliance with regulations.
Integrated CRM functions
Next to the clinical trial data management the recruitment and care for clinical trial investigators is a central criterion of quality of the CTMS software. BSI CTMS provides a decisive advantage here: It is based on the proven BSI CRM application deployed worldwide and contains all functionality for a professional investigator relationship management.
Individually adaptable to customer-specific processes
BSI CTMS is 100 % based on Service Oriented Architecture (SOA), on Java and Oracle databases proven in the pharmaceutical industry. Thanks to this open architecture BSI CTMS was easily customized to the individual needs of Actelion. This also applies to future BSI CTMS customers; the software is adaptable and extensible to specific processes without problems or significant cost. Each pharmaceutical company has its own specific process for clinical trials. This puts special demands on CTMS software. Off the shelf solutions can seldom meet those demands or only at a great additional financial cost.
Actelion Pharmaceuticals Ltd.
Founded in 1997, Actelion is a biopharmaceutical company with headquarters in Allschwil/Basel, Switzerland and branch offices in 22 countries. It is world leader in Endothelin research, a cell layer that separates the vascular wall from the blood stream. Actelion is specialized on the research, development and marketing of innovative drugs in areas with high medical needs.
More information
Jens Thuesen, BSI Business Systems Integration AG, Täfernstrasse 16a, CH-5405 Baden
T +41 (0)56 484 19 23, F +41 (0)56 484 19 30, jens.thuesen@bsiag.com, http://www.bsiag.com
BSI creates intelligent customer relationships. BSI is the Swiss company for successful software solutions: with BSI CRM it provides the leading Swiss product for Customer Relationship Management. BSI Counter is a Point of Sale product, and BSI CTMS is used for clinical trials in the pharmaceutical industry. BSI also specializes in services in the systems integration, software development, general contractor, consulting and support areas. BSI does work for the Swiss Post, Sika, PricewaterhouseCoopers, Roche, ABB, Landis+Gyr, Swiss Life, sunrise and other customers in the finance, pharmaceutical, professional services, manufacturing and logistics industries.
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