Lab partners

An Executive Interview with QMR Technology

NGP speaks with Willem van Leeuwen of QMR Technology about the benefit of teaming with a specialist IT provider for clinical trials.

NGP. Clinical trials are becoming increasingly global in nature. What challenges does this present to the pharmaceutical sector?
Willem van Leeuwen. Globalisation of clinical trials means greater complexity, especially in data management. Expediting the multinational regulatory process without sacrificing quality is critical. For clinical data to be defined, managed, and interpreted consistently worldwide, companies must be able to standardise, disseminate, and control data definitions across concurrent global operations.

NGP. What solutions can companies like QMR provide to help pharma companies deal with this changing environment?
WvL. The global nature of clinical trials asks for a solution that can handle the management of international clinical trials. The study data definition subsystems must enable a single study to be defined and conducted at several worldwide locations concurrently, with minimal additional effort. The essential subsystems must include global library management, study data definitions, a data validation facility and lab reference range management.

NGP. What advantages does a database containing a number of reusable components offer?
WvL. Usage of reusable components enables the clinical study managers to setup a complete new clinical study within a much shorter timeframe. Within the global library, reusable components are standard versions of study collection objects which can be used as building blocks in multiple studies. Examples of standard questions are birth date, patient’s heart rate, and patient’s blood pressure.

NGP. How can companies manage requirements for medical dictionaries?
WvL. One of the most time-consuming tasks within the drug development process is classifying verbatim terms to permit deriving of standard medical and drug terms for use in analysis from the free text originally captured. The thesaurus management system we offer can handle more than 100 dictionaries and is also designed to handle the complexities of the medical dictionary for Regulatory Activities (MedDRA). The thesaurus management system supports any number of hierarchies and allows access to any number of dictionaries, including multiple versions of the same dictionary which have been created over time.

NGP. Life sciences companies are under constantly increasing pressure to reduce the time to market. How can they reduce the time needed to demonstrate the safety and effectiveness of a drug candidate while maintaining the highest level of data quality?
WvL. Competition today requires organizations to increase operational efficiency and also to fundamentally change the research process itself. This requires the ability to improve product development cycles and reduce product time to market. With Electronic Data Capture (EDC) systems the data collection and data cleaning processes can be speeded up, which reduces the time and money spent on clinical trials. This is of vital importance, considering that each additional day that a drug spends in clinical trials can cost a company over €630,000 in lost revenue and up to €6.3 million for a blockbuster.

NGP. What specific solutions does QMR provide?
WvL. We provide a full range of products for clinical research, including clinical data management systems, medical dictionaries, adverse event reporting systems, and specific products for the management of administrative, financial, and regulatory aspects of conducting clinical research and the management of investigative sites. Our services portfolio includes database design & installation, setup of study and protocol design, database upgrades, validation, design and review of standard operating procedures and product training. Furthermore, due to the small scale of our business we are able to provide these products and services at very competitive rates.

Willem van Leeuwen is Managing Ddirector of QMR Technology. His experience portfolio includes numerous successful implementations of the ERP solution Oracle E-Business Suite and the clinical data management system Oracle Life Sciences Applications within a diverse range of companies.