Ask the expert – QMR Technology

• What can companies like QMR Technology do to help organisations take advantage of these state-of-the-art software solutions?
  
• What are the core products available?
  
• What benefits do these software solutions provide – for example, how do they help companies manage the manufacturing and distribution of treatments in clinical trials? How can they help compile important data required for compliance?

Developing companies within the life sciences industry are faced with specific challenges: they have small budgets available, need to minimize cashburn, are under constant pressure to reduce time to market and at the same time they must comply with constantly changing and increasingly stringent regulations. Also, globalization of clinical trials means management of a complex multinational regulatory process.

Compliance is a matter of survival. As all life sciences companies are dependent on capital for their continued operation, compliance with corporate governance regulations will be the first barrier to take: the company should have internal risk management and control systems in place to ensure compliance with corporate governance regulations and standards.

Whenever a candidate drug has been selected that has the potential to become a commercially viable drug, it will have to undergo rigorous clinical trials which will have to prove both safety and efficacy. This is where the second part of regulations comes into the picture. The increasing international nature of clinical trials asks for a solution that can handle multicenter trials and provide the necessary reporting, both financial as well as adverse events reporting. The regulations are set by various authorities and are subject to changes. Life sciences companies which have opted to develop inhouse systems, must make significant investments in order to satisfy the regulations and follow the changes. It is a time consuming process to get these systems to satisfy the changed specifications. Even larger pharmaceutical groups – with large IT budgets – struggle to provide an integral solution that satisfies all requirements. In addition, clinical trials systems are critical business systems for every life sciences enterprise, in view of the fact that clinical data is generally the most valuable asset.

The Oracle Life Sciences Applications Suite consists of a state-of-the-art clinical data management system and optional components like Thesaurus Management System which will provide a centralized, globally available repository of medical dictionary terms supporting commonly used dictionaries a MedDRA and WHO-Drug. Oracle’s acquisition of Siebel also brought the world renowned Customer Relationship Management (CRM) functionality within range of the Oracle Clinical solution. With the Siebel Clinical Trial Management System relationships with trial participants like investigators and subjects can be effectively managed. Integration of the CRM system with the Clinical Data Management solution ‘Oracle Clinical’ will prove an easy issue because both applications are based on the world-class Oracle Database.

Depending on the business model the company has chosen the company might also have to invest in GMP compliant manufacturing facilities, creating a technology infrastructure that enables the organization to effectively track compliance with complex FDA requirements while at the same time streamlining production processes. Companies are required to employ procedures and controls to ensure the authenticity, integrity and, when appropriate, the confidentiality of electronic records. These regulations deal with electronic records and signatures and audit trails.

QMR Technology has teamed up with Oracle Corporation and can now provide a cost-effective approach for delivering industry specific applications of Oracle: the E-Business Suite for financial accounting, process manufacturing and supply chain planning processes, and the eClinical Suite for the management of data obtained in clinical trials. These solutions effectively support the business processes of life sciences enterprises and streamline clinical trial management, logistics and manufacturing processes. In addition, commitment to life sciences industry ensures added value compared with other suppliers.

Small and medium-sized enterprises within the life sciences industry benefit from the timely implementation of scalable information systems which effectively support their business, and provide compliance in the field of financial regulations and reports on clinical trials. Many small enterprises make choices based on existing needs within certain departments, and once the enterprise has grown and many people from various departments are exchanging information, problems tend to arise, as the software suppliers have not accounted for standard interfaces, or the software does not conform to open standards.

These problems can be avoided from the start, by choosing a system that grows in step with the business, and substantial savings can be realised. Smaller life sciences enterprises in particular, often have insufficient capacity available to define workable standards for interfaces. Devoting attention to this too late (within the strategy for information management) can prove expensive at a later stage. When migrating various information systems to a more coherent solution such as an ERP package, many different disciplines are drawn in so as to make a smooth transition possible. I know of a particular case in which a team of 100 project workers is involved in facilitating the migration of various information systems to one single global ERP instance; unnecessarily expensive and time-consuming!

In terms of licences, there are many price-related advantages associated with early purchase. There are attractive discounts available for life sciences companies in the Small & Medium-sized Enterprises sector compared to the regular licence fees. Software companies like Oracle leave this market to partners specialised in industry related products and services that have extensive knowledge of the market and business in which their clients operate. Suppliers also often want to gain a larger market share within these specific sectors for reasons of competitive considerations. Large purchase discounts are therefore offered to partners, making the purchase price very attractive for these SMEs.

It is clear that standard and compliant systems must be embedded in the development of the enterprise at as early a stage as possible, and that standardised processes are necessary in order to be able to offer optimum support for new clinical trials during the life cycle and at the same time to satisfy the regulations. Particularly in view of the large discounts applicable for smaller enterprises, the price of these systems should no longer form an obstacle.