As contract research organisations become increasingly involved with clinical trials, their logistics take on a new importance.A newly-launched initiative aims to reduce both the time andcost involved in this biomedical transport.
Information technology, especially web-based integration and communication solutions, is seen as critical to the achievement of targets set by life science companies. In the case of clinical trials these demands are compounded by the need to move materials between locations, not only in good time but also in good condition.
Clinical trials can last from one to eight years depending on the stage of development and involve up to 20 000 patients often spread over several countries and continents. It is no surprise therefore that laboratories typically spend between 20 per cent and 30 per cent of their revenue on logistics while the total value of Europe's biomedical transport market is estimated to be US$60m.
The latest entrant into that market is TNT Express, which in October launched the Clinical Trials Network, a new service for pharmaceutical industry companies that will reduce time and costs of clinical trial shipping logistics. CTN enables contract research organisations (CROs) plus investigators, central laboratories and pharmaceutical companies to schedule collections and track shipments of trial samples and dry ice online.
TNT Express expects investigators using the CTN facilities to reduce the time spent preparing and tracking clinical trial shipments by approximately 50 per cent compared with the traditional methods of telephone and fax ordering. In addition, the system offers online access to trial-specific tracking information of sample shipments and enables central laboratories to manage the scheduling of laboratory staff using real-time information of sample shipment arrivals.
The main advantages for CROs and laboratories are that it enables instant consignment tracking and tracing, gives the ability to plan resources and staff control in advance, and improves process visibility and control. Having a single source for dry ice also improves cost control.
For investigators, the network removes the need for phone calls to couriers, gives immediate access to dangerous goods information and allows all site staff access to logistics information that allows them to book collections and dry ice with a few mouse clicks. Pharmaceutical companies also benefit because new logistic efficiency should cut trial time and cost.
"CTN is an innovation that will draw attention to the importance of shipping logistics in the clinical trial process,“ said John Butterworth, global industry director life sciences of TNT Express. "We know from our customers that effectively managing shipping logistics can greatly impact the overall success of a clinical trial.“
Improving shipping
A recently-conducted TNT Express customer survey underscored the significant role shipping logistics play in clinical trial processes. In the survey, which included participants from central laboratories and pharmaceutical companies, 84 per cent of respondents said that improving shipping logistics can reduce the total timeframe of clinical trials. 95 per cent of customers believe that problems with shipping logistics can make clinical trials more expensive. Other findings include: u All customers surveyed believe that the logistics of moving samples from one place to the other is important to the success of clinical trials, with all central laboratory respondents stating this is avery important'. u 95 per cent believe that improved shipping logistics can increase the scientific value of the clinical trial. u All pharmaceutical companies surveyed believe that problems with lost or damaged clinical trial samples make clinical trials more expensive. u Nearly all central laboratory respondents (92 per cent) want to be able to track the clinical trial sample packages online/via the Internet, with the majority of those respondents (58 per cent) saying that this is avery important'. These respondents also believe that it is helpful to know when the clinical trial sample packages will be delivered to the laboratory. u 85 per cent of central laboratory respondents also thought it would be helpful to be able to order dry ice and schedule shipments online. u Nearly half of the central laboratory customers respondents (46 per cent) have often experienced the problem that the ainvestigator wasn't sure of shipping regulations of dangerous goods'. u 62 per cent of central laboratory contacts believe that investigators are not aware of their legal responsibility to ensure that the clinical trial samples they ship must meet the International Air Transport Association's regulations for the shipment of hazardous goods. u 89 per cent of respondents believe that technology will be very important to improving the speed and process of conducting clinical trials.
"The biggest problem related to clinical trials logistics can be that investigators have trouble filling out the shipping forms which is often time consuming,“ said Arne Koscielny, an investigator in Germany, who participated in the pilot programme testing CTN. "This is made easier with CTN, as you now have a guide that tells you what to fill in and what information you need to include. This often helps to save time.“
Pharmaceutical companies are increasingly looking for technology solutions to streamline the clinical trial process and ultimately wish to reduce product development costs to boost profit margins. An industry survey of pharmaceutical R&D executives conducted by the consulting firm Accenture revealed that 54 per cent of those surveyed believe that internet-related technologies are fundamentally changing their R&D processes. 60 per cent of those surveyed said they will capture and transmit clinical trial data electronically in the future versus 14 per cent doing so today.
According to Accenture integrating web-based information/communications infrastructure into the development of drugs is astill an emerging concept'. In addition, most information in clinical trials is still shuffled on paper between clinicians, statisticians, co-ordinators and regulators.
For more than a decade TNT Express has been the European market leader in the shipment of clinical trial samples and currently has a 30 per cent market share in this field. In addition to offering online CTN services, TNT Express supplies dry ice and specially designed packaging materials to investigators on request. TNT also operates a specialist warehouse facility for medical and pharmaceutical products that offers end-to-end logistical solutions to the pharmaceutical industry.
