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European Biopharmaceutical Review

Shaping a Solid Foundation

Thomas Ermlich at Medidata Solutions Worldwide explains how companies can maximise their eClinical strategies through process optimisation, technology implementation and industry knowledge

When making the commitment to implement an eClinical strategy, it is imperative to plan an approach that will ensure success. A decade ago, most biopharmaceutical companies had grand visions of implementing electronic data capture (EDC) as a way to automate and streamline manual processes, increase decision-making capabilities, and decrease drug development timelines. In fact, many companies went well beyond the scope of EDC and were recognising the importance of developing eClinical strategies that would cover a much broader scope of the drug development spectrum.

Then the turmoil in the world economy began. The dot-com bust and the technology downturn sent shockwaves throughout the global markets. The biopharmaceutical industry, which in the past enjoyed some level of insulation from the general economy, was dramatically affected, particularly as it was related to investment in web-based technologies. Many EDC and eClinical companies went under or were consumed by larger organisations, and it seemed that things would never be the same again.

But then, as the economy slowly recovered, the technology improved, and progress raised the bar, EDC and eClinical solution providers rose from the dust. Slowly but surely, the healthcare industry again began to see the potential for technology investments to transform their business.

The trend that has emerged over the early and mid-2000s is that, rather than prototyping and piloting EDC on a small percentage of trials, many sponsors began aggressively moving toward full adoption of EDC, and some are well on their way to implementing eClinical strategies that tie in the full drug development process. The days of analysing and justifying technology investments have now been replaced by the need to accelerate full scale eClinical implementations rapidly. And this time, the downturn in the global economy is providing motivation to implement, rather than stifle, innovation as it did a decade ago.

So now the challenge becomes how to strategise, plan and implement an integrated platform of solutions that will transform drug development business. It’s not an easy task, and without the right expertise, approach and experience, it could prove to be insurmountable.

Although there are many angles that must be considered carefully, the three main components required to implement an effective eClinical platform successfully are process, technology and current industry knowledge. Although it is a much easier task today to decide on which technologies to implement, it is important to take a holistic approach that encompasses each of these components.

PROCESS OPTIMISATION

Let’s begin with process. Although it has not always been the case, most people now agree that implementing new technology without considering process change is a mistake. It is true that new technologies bring the obvious advantages of reducing paper, eliminating or minimising human error and automating manual steps. However, by continuing to follow processes designed for a manual, paper-based model, the efficiency gains can be severely limited. It is the identification of bottlenecks, streamlining steps and optimising processes that can lead to achieving maximum efficiency goals.

This sounds easy enough, but without the right level of experience in doing so, it is easy to hit some of the common pitfalls. Some typical mistakes include overestimating the capabilities of the technology, failing to incorporate meaningful measurements, and forgetting to build in contingencies. When done correctly, newly released processes will prove to be realistic, measurable and resilient.

A number of different approaches may be taken, ranging from review and optimisation of existing processes to the ‘clean slate’ method of designing completely new processes. Organisational constraints, such as budget and timeline, will help to determine which approach is most appropriate and achievable. Hands-on experience is important with both approaches, so it is critical to have this on your team.

TECHNOLOGY IMPLEMENTATION AND ARCHITECTURE

The next building block of any successful eClinical strategy is technology implementation and architecture. Even the best tools can be rendered useless if they are put into place without thoughtfully planning for the implementation of all technology components. Careful consideration of platform, connectivity, performance, stability, scalability, validation and contingencies are all necessary to make sure your technology investment will meet business requirements and user expectations.

Most of the software currently available on the market is based on proven, state-ofthe- art technology; however, this should not be taken for granted. If not given due diligence, you may find out too late that a product is built on out-of-date platforms that are not compatible with other components, or not scalable to today’s demands.

Prototyping or piloting is not always enough to prove your solution will, in reality, support the full potential of your clinical business. This can be countered by conducting extensive load testing, which can be expensive or difficult to achieve. An alternative to load testing is to conduct thorough benchmarking to be sure the technology is up to the task. Technology providers should be able to provide references or customers who may be willing to assist. However, the most cost-effective and expeditious approach is to bring experienced partners onto your team. Again, there’s no substitute for hands-on experience.

INDUSTRY KNOWLEDGE

The third essential eClinical strategy component is current industry knowledge. This is a crucial area to consider, because it provides the right context to your initiative, no matter how small or large. Industry knowledge goes far beyond simply planning for process change and technology implementation. This component encompasses industry standards, skilled staff, training and the best practices required to support your solution for the long term appropriately.

Once again, comparing where we are now to where we were a decade ago, many standards have emerged, matured and stabilised. Regulatory agencies, sponsors and vendors now have a more ‘common language’ when it comes to platforms, data structures and terminology. Standards are no longer just a good idea and a goal; the industry now requires them in some areas and strongly recommends them in others. Those who embrace standards have accumulated evidence of significant cost savings achieved as a direct result of reduced implementation times, re-use and consistency.

Identifying, recruiting, hiring, motivating and retaining skilled staff are aspects of industry knowledge that will make a significant difference in organisational effectiveness and performance. People are your most important asset, so it is crucial to build and develop a strong team, whether it be from the existing organisation or expansion.

Training is the next logical element of industry knowledge. It has also become a necessity in our regulated environment. It is not enough just to document new processes; there needs to be an effective way to put processes into practice for existing personnel and for new staff coming on board as a result of expansion or routine turnover. Planning for an effective training programme with continuous feedback and improvement is a must.

Industry knowledge also means best practices. As with any technology or associated process, there are numerous ways they can be carried out. Over time, it becomes clear that completing steps in different ways can lead to significantly different expenditures in time and effort, while still achieving the same result. Repeated usage drives out the precise details not specified in standard operating procedures or even in detailed work instructions. Experience leads to best practices, which should be documented and shared through training and mentoring. This is all well and good, but difficult to attain on any new implementation. Again, this is where bringing the right people, with the right applicable experience, onto your team can prove to be invaluable.

BRINGING IT ALL TOGETHER

When clinical development organisations recognise that process optimisation, technology and architecture, and current industry knowledge are important pillars of their eClinical strategy implementation, they increase their odds for success. Leaving out any of these vital elements will allow gaps in your implementation that can jeopardise the results.

Even the best tools and the best staff can turn out uneconomical results that can cost an organisation more than the intended savings. And even worse, choosing the right technology, developing solid processes, and assembling the right team without an adequate training programme can lead to ruinous mistakes, resulting in devastating regulatory penalties.

However, by including process, technology and current industry knowledge as fundamental aspects of an eClinical implementation, you can increase the probability of success.


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Thomas Ermlich is a Client Services Principal at Medidata Solutions Worldwide, where he oversees broad scale implementations of Medidata’s products for large accounts. He joined Medidata in 2007 with 20 years of experience at Merck & Co, Inc and Johnson & Johnson, Inc, where he implemented, supported and managed systems enabling all aspects of pharmaceutical research and development.
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