Critical thinking

It has been at least 25 years since technology first began to play a role in clinical research. Nowadays, technology solutions are available for almost every discreet process involved in the performance of clinical research – from subject recruitment and reimbursement to site training, from site-based data collection to electronic subject diaries, from site monitoring to drug supply management. To many in the clinical life sciences, however, technology is seen at best as a costly necessity. Why is this?

Many clinical research professionals believe that clinical research is a special case, where regulatory requirements drive the need for unique, complex and expensive systems requiring extensive validation. Also, technology tools in clinical research must be robust (capable of supporting many users) and stable (so that it always works). Indeed, technology used in clinical research is not particularly unique in this regard. For example, in the financial industry huge amounts of rapidly changing data must be available securely in real time, with regular data transfers to other applications or systems. Other industries such also have similar requirements, for example in human resources in large organisations – personal details of employees must be held securely and updated regularly, with perhaps data transfers to the payroll system each month. Such systems must also be secure and validated, and so parallels with clinical research are apparent. Therefore, the environment for deployment of technology in clinical research is perhaps not so unique.

Some may also hold the view that validation of life sciences technology is detailed and costly, leading to acceptance of higher prices (and less innovation) in the industry. When it comes to validation, however, there are two schools of thought. In the first, the validation process is undertaken solely by validation experts in order to ensure that the system meets the regulatory requirements, using what amounts almost to a checklist approach.

Those who support the alternative school of thought believe that validation should be viewed as an opportunity to pair validation specialists with technology experts to not only check that the application is ‘valid’ in relation to the regulatory requirements, but also that the technology is the best available to meet the needs of the individual users and the greater goals of the customer (i.e. the quality is high). The first approach to validation encourages an environment in which technology is validated but lags behind the state-of the-art. The second approach not only ensures validation in the strictest sense, but also promotes new approaches to support the work of the client.

It could be argued that the view that clinical life sciences are a ‘special case’ has slowed the adoption of the latest technology and fostered an environment in which technology companies serving the industry are able to justify high costs for the their products. Whilst the cost for technology typically decreases over time as new knowledge and more powerful systems help to develop more efficiency and greater competition, the opposite seems true in the clinical research industry. When the mobile telecommunications industry first arrived, devices, line rental and calls were all extremely expensive. The situation is entirely different now, to the extent that the majority of us have access to cheap mobile telecommunications. Technology in the clinical life sciences arrived at approximately the same time as mobile phones. The question could be asked why technology in the life sciences has not also become more affordable in the same period.

Perhaps this reflects the ‘comfort factor’ of selecting a large, well known supplier whose technology may be a few years behind that deployed in other industries and whose costs may be very high. Perhaps it is a misplaced perception that when it comes to technology, the clinical life science industry is a special case. Whatever the reason, in many cases this situation means that clients are paying more than they need to for yesterday’s technology. Ultimately this means that budgets are stretched, less clinical research activity is performed, and perhaps fewer medicines are developed.

Techorizon offers a new approach to the life sciences industry, with senior staff who have experience in not only clinical life sciences technology, but also in technology deployment in other industries with similar requirements. The team also includes several members with operational experience in delivering clinical life science projects. By utilising the latest technology and leveraging our knowledge of best practice in other industries, our clinical life sciences team have developed a new approach where applications based on the latest technology are quickly and easily customised, are fully validated to GAMP 5 standards and compliant with CFR 21 Part 11 and are delivered to the customer at much more affordable budgets than existing tools. The challenge to the market now is to be open to evaluate the new these technology approaches.