Capgemini Global Service Desk - at the Heart of AstraZeneca Clinical Trials Data Management
AstraZeneca PLC is one of the world's leading pharmaceutical companies. Corporate headquarters are located in London, with more than 50,000 employees worldwide.
AstraZeneca is a provider of innovative medicines for serious health problems in seven important therapeutic areas: cardiovascular, central nervous system, gastrointestinal, infection, and oncology, pain control and anaesthesia, respiratory.
Research & Development (R&D) centers of excellence are located in Sweden, the UK and the USA. 12,000 people are employed in production in 20 countries.
An extensive global sales and marketing network is present on all continents and employs over 25,000 people.
The merger of Astra AB Sweden and Zeneca Group PLC, UK created AstraZeneca, with the market presence and power to deliver revolutionary medical advances to patients worldwide. The merger represents the combination of two companies with similar science-based cultures and a shared vision of the pharmaceutical industry.
Business Requirements
Because drug development and licensing takes so long, any reduction in the time spent on this process means that products are launched to market faster. This translates into increased revenue and cost savings. There are specific areas where IT support is key to making business processes more effective:
Clinical Trials
Clinical trials are carried out by doctors on specific groups of patients. In
a trial, which can last from a few months to several years, as many as 15,000
patients can take part. The trials are administered in a large number of investigation
centers (usually hospitals). A detailed record of the trial for each patient is
kept on the Case Report Form (CRF).
The AstraZeneca, R&D companies manage trials, but it is AstraZeneca marketing that has direct contact with the investigation centers.
The volume of data recorded for each patient is very high. The information held on the CRF needs to be made available, securely and quickly, to AstraZeneca, R&D. Speed in the information collection process is vital in order to make data available for analysis.
Regulatory Affairs
When a pharmaceutical company applies for a licence to market a drug, the regulatory
body requires detailed documentation which includes evidence from clinical trials.
Regulatory authorities need to check all information and decide whether it is
safe to sell the drug on the market. Therefore quality and speed of information
retrieval is essential in order to avoid delays.
System Requirements
AstraZeneca had legacy IT systems in place, used for data management and clinical trials. The system needed to be able to clean, code and provide data for statistical analysis, more specifically, the system needed to:
- provide the Marketing and R&D companies with a common IT system to process clinical trial data in a controlled and secure manner
- be able to check patient data, and code the information in the CRF, according to international reference dictionaries.
- adapt to the strict regulatory requirements of the USA, Food and Drug Administration (FDA). Information must be of the highest quality and the information collection process must follow very strict rules.
The Capgemini Solution
AstraZeneca already had an in-house help desk provided by Local Support Managers. Capgemini was asked to put in place a service desk to provide an additional second level for problem and change management. This service desk handled problems which the help desk were unable to resolve or enhancements reported which warranted changes to the system.
AstraZeneca’s IT system for Clinical Data Management is at the ‘heart of information flow’ during clinical trials. It is a validated system, able to pass inspection by regulatory pharmaceutical authorities.
- Capgemini’s Applications Management service ensures that:
- applications function correctly on the Clinical Data Management System
- service will evolve, consistent with changing user requirements and new system releases
- error and administrative reports are treated quickly and accurately
A report-handling, web-based solution, designed and specified by Capgemini, is accessible via an intranet and serves approximately 1500 users. It is used by the service desk to handle user requests and problem reports.
The AstraZeneca international help desk is located in Mölndal, Sweden outside Goteborg. Staffed by Capgemini, the emphasis is on providing multilingual help desk support in English and Swedish for complicated questions from AstraZeneca users in 30 countries, worldwide.
The Benefits
Effective processing of clinical data is essential in the race to be first on the market with new drugs. Although time is important, the quality of data has to be secured. Question marks on the quality of data can cause FDA or other authorities to withdraw the license to sell the drug.
AstraZeneca benefits from having Capgemini’s proven 30-year record in delivering Applications Management (AM) services. Capgemini delivers these services using its standard ISO 9000 compliant AM PERFORM methodology. The use of these AM Best Practices and tools provides AstraZeneca with timely, dependable and cost-effective support.
AstraZeneca is now free from problems of staffing a second line service desk, permitting key IT staff to concentrate on specialized performance in pharmaceuticals.
With a strong research base and a powerful product line, AstraZeneca offers improved benefits to patients and a business performance that delivers value to shareholders, employees and business partners.
Written in cooperation with Astra Zeneca PLC
Contact: Capgemini Sverge, Goteborg, Life Sciences and Chemicals GSU