The case for intelligent clinical trials processing

As the business process in question didn’t drive competitive advantage or growth, the high-volume and relatively low-value task, which required the capture and processing of millions of paper documents with 100 percent accuracy and extraordinarily high levels of security, seemed a likely candidate for outsourcing. But because it was essential to customer and market confidence in the companies, they couldn’t be seen as separating themselves from it entirely. The firms had complex global operations and many diverse and far-flung business units. Furthermore, the companies, like the industry itself, were generally risk averse and considered slow adapters of technology.

Cost pressures made the situation urgent, however, and the companies decided to form a joint venture with a leading consulting and technology firm. The solution they designed was built around shared services centres outfitted with the latest technologies. By going paperless, the firms were able to increase accuracy and validation, while still complying with strict regulatory requirements. And other benefits resulted from the redesigned processes. Security and audit trails were improved as the companies had better records of the transactions. Cash flow increased as capital was liberated from the cost-intensive process. In fact, the JV model proved so successful that soon other firms in the industry expressed interest in participating, and were allowed to do so on a fee basis. The founding partners realised significant appreciation on their original investments.

So who are the companies to which we refer, and what is the process? Barclay’s Bank and Lloyds Bank, two leading lights of the British financial sector, who formed Intelligent Processing Solutions Ltd (IPSL) with Unisys to overhaul their cheque clearing capabilities. Many other banks have hired IPSL, and HSBC has bought a 10 percent stake. One analyst described IPSL: “This partnership jointly tackles a process that was too complex for the banks to tackle alone.”

The pharma connection

We share this example because of its relevance to today’s pharmaceutical industry, specifically the need for improved support of the clinical trials process. There are many similarities between cheque processing and clinical trials processing. Many different communities, with sometimes conflicting needs, participate. For instance, pharmaceuticals are looking for maximum quality, reliability and visibility into day-to-day activities, while clinicians are concerned with the integrity of the study and CROs seek efficient transactional throughput while still retaining niche therapeutic relationships. Like cheque processing, clinical trials require several steps to be completed. And both involve a formidable regulatory presence and a pressing need for security.

The lack of standardised data, which negatively affects both processes, is yet another similarity. The often illegible scribbles on cheques look very much like the scribbles on CRFs, patient applications and clinicians’ notes. Although no communities involved in clinical trials are willing to have standards imposed upon them, standardisation of data, processes and technology would help solve several of these challenges.

But, the main reason we draw this parallel is to share the good news that highly complex, non-differentiating processes can be managed more effectively through collaborative efforts and shared risk and reward across an industry.

Point solutions only moved bottlenecks

In the past, pharmaceutical firms have been acting on their own to improve their processing of clinical trials data. Roughly ten years ago, they turned to document management systems to more efficiently manage the tidal wave of paper that threatened to overwhelm clinical trials processing. They met with only limited success.

Five years ago, electronic project management was identified as the solution. The pharmas would gain better insight into overall status and improve communication across the many participants in the trial process. Again, they met with limited success.

In the last few years, companies have turned to electronic data capture. No more pen and paper – or at least a lot less. It may be a little early to determine the success of these efforts, but the gains in cost and process efficiency are likely to be limited as they seek to serve only one audience. By adopting a piloted approach within a single channel, pharmaceuticals reduced the likelihood of success of their electronic data capture initiatives. Had they implemented automated data capture for multiple channels, with individuals able to select their mode of data entry, pharmas would have greatly increased their likelihood of user adoption and, therefore, overall success.

With each of these ‘point solutions’, companies have succeeded in simply moving the bottlenecks around. Their efforts have been hampered by:

• Limited resources to invest.
• A lack of urgency around the need to improve data processing.
• Most significantly, a narrow view of the problems.

Individual components of the process have been marginally improved, but none of these approaches has considered the needs of every community that participates in clinical trials. Because it’s easier to build business cases for narrow applications of technology and because individual business units often provide the funding, pharmas have overlooked the big picture and simply continue investing in ‘one-off’ projects.

But these solutions have underscored the breakdowns across the entire system. In fact, it’s fair to ask if the point solutions have actually made the situation worse by introducing more complexity in terms of steps and systems. Have the limited gains been worth the further moving away from commonality and integration?

A new, holistic approach

With growth rates slowing, fewer blockbuster drugs entering the market, and regulatory oversight intensifying, pharmas are looking to streamline every aspect of their operations and eliminate all delays from the drug development process. The problem of clinical trials processing has become urgent in today’s tight market. There has been increasing recognition across the industry that the issues are simply too difficult and complex for any single pharma to solve on its own. And because the entire industry stands to benefit, support for collaborative efforts has been gathering steadily.

To facilitate change and resolve the complexity of clinical trials, the industry will need to adopt a broad, big-picture perspective. Only an end-to-end solution will do. It’s now widely understood that building a consortia including global pharmaceuticals, investigators, technology and consulting firms and regulators is the smart way to address a challenge of this magnitude. Such a strategy is the likely the best smart response to ensure the needs of each constituent group are served – from clinicians, CROs and investigators to patients and regulators.

The key to the solution is a completely secure and integrated technology and information infrastructure that leverages existing technology and provides connectivity, via the use of open standards, to all groups. Clinicians can still use whatever means they prefer – paper, digital or voice – for data submission, while validation and cleansing are automated by image processing and document management systems. Formatting, delivery and assurance are also handled electronically. By allowing faster data capture with validation closer to the source, there is less re-working and correction of documents, which allows “database lockdown” to be achieved in less time. Similarly, CTMS and SAS systems are supported by application service provisions and are treated as components of the whole solution. Instead of the limiting, application-centric approach that has lead to substandard performance to date, systems are built around the information itself. Cost and efficiency gains would occur during every phase, from Phase I (early entry to man) to Phase IV (market approval).

What’s intelligent about this clinical trials processing system is that it minimises disruption of current trials. Though new thinking is required to frame the solution, the implementation of the solution itself will be evolutionary, and build on the gains of yesterday’s point solutions. For instance, document management and CTMS software will continue to play significant roles for those who use them. No individual group will be asked to sacrifice its preferred mode of operation.

Next steps for pharmas

What are the potential gains that can be used to justify increased investments in intelligent clinical trials processing? Improved overall performance would allow the phases of the trials to be concluded more quickly and the risk of failure to be reduced. The elimination of even a single day could mean savings of up to a year’s manufacturing costs. Overall savings could reach as high US$50-$100 million per compound. Knowledge sharing allows the cost and performance improvements to be duplicated across multiple trials. And because existing technology and organisations can be re-used, it’s possible to drive higher returns on previous investments. For pharmas, there are several next steps:

• They need to measure their cultural and organisational willingness to embrace open standards and non-proprietary, collaborative problem-solving.
• They need to seek the right business partners who can provide insight into the issues and thought leadership as to the solution.
• They need to find advocates and allies among the various parties that participate in clinical trials.
• They need to build on their heritage of quality delivery, ethical values and longevity so that they can see their long-term vision through to completion.

It’s important to remember that the development of an intelligent clinical trials processing solution will take time. The problem is complex, but the benefits of reduced cost and mitigated risk are too great to ignore in the current market environment. Because it maximises sales potential by speeding product development and launch, intelligent clinical trials processing has become a high priority for leading pharmas, as well it should be. What was once was considered a non-differentiating activity (a necessary evil, if you will) now provides the opportunity to secure real competitive advantage via faster drug development cycles and increased sales during periods of exclusivity.