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International Clinical Trials

Transformed Reality

Pharmaceutical companies are particularly attuned to the value of thinking in new and innovative ways. Many novel drugs and therapies trace their roots back to a scientist who thought differently and took a fresh approach in treating a disease.

But this notion of innovation does not begin, nor end, with the development of new medicines for business advancement. After all, at the core of the pharma industry is the innate desire to cure disease, help patients and provide quality care. Quality is essential for the wellbeing of any organisation, as well as customer satisfaction – and pharma and life sciences companies are at the forefront of establishing new and improved ways to ensure quality for clinical trials and accelerate time to market.

Laying the Groundwork


Before discussing ways in which organisations can go about improving electronic clinical trials, the idea of a digital transformation must first be considered.

In a recent survey, business leaders expressed concerns over how difficult it was to achieve the digital transformation goals they set for themselves. In fact, only 14% report having “fully migrated to all intended areas of their digital business transformation plans”. Meanwhile, 48% indicate that they have changed to some, but not all intended areas.

In order to make significant strides to improve the speed, quality, safety and outcomes of clinical trials, companies must first analyse the extent to which they can answer the following questions:
  • Are you mobile? Mobility is important to gain alignment with all players, from regulators and sponsors to trial participants and process managers. Information should flow in real time, so work is done more quickly and all parties get what they want, right when they want it
  • Can all players capture and share information from outside a controlled environment, or even at home?
  • How do you enable work that may happen in the field, addressing needs like remote information capture and access?
  • More importantly than access, are participants able to accomplish providing feedback and engaging on a mobile device? Flexibility has become a lifestyle, and this holds true in every aspects of a person’s life, including work. Give people the ability to get the job done more easily, whenever they want, wherever they happen to be
  • Does your organisation allow information to be shared with you via mobile devices?
  • Is your company able to interact with them in the way they prefer? Are you set up to capture data from these populations?
  • Are you inclusive? Your greatest organisational strength is largely untapped, which is your staff and their ideas. These synergies happen when your entire workforce is empowered to effortlessly share and learn from ideas, comments and knowledge of others. Proactively pursue inclusion
  • How do employees share ideas and information at your company? By email, in meetings or in phone calls? These are all exclusive by nature – you must be added purposefully to be included. Case managers need to know certain milestones and access the most current information. But, what if more context and information could be provided by staff not considered to be directly involved?
  • How rigid is your organisational structure? Can anyone truly contribute ideas, information or improvements? Or is there a hierarchy that causes certain groups or individuals to keep quiet? Tear down the organisational silos that impede transparency
  • Do you have a way to proactively push information and milestones from systems to the people that can take action? What about those who do not need it, but could add value? Take advantage of technology built for the ‘now-now-now’ economy. By sharing milestones as they happen more broadly, you will uncover additional information – and, more importantly, added context
  • Are you agile? Agility is paramount to drive product innovation, develop new and better ways to do things, and quickly deploy these to outpace competition
  • Do your legacy systems get in the way of progress? If your current systems are not fully integrated and leveraged in a single environment, you will be slower than your competition
  • How quickly can you address change? Are your internal processes, systems and protocols rigid? Can you take advantage of new information, trends and innovation immediately? Does the technology you employ allow you to instantly change how things operate so you can navigate constant change coming from anywhere? For example, the Internet of Things is a disruptor that is already well on its way to mainstream relevance. Are you prepared for a world where adaptability is the most important organisational attribute to achieve success?
Mobility

It should come as no surprise that mobility is a key component to brightening the future of digital clinical trials. Mobile devices have become completely engrained in our daily lives, literally from the moment we wake to the moment we lay our heads to rest. We now expect that our smartphones will tell us – often without us asking – what time we should leave for work to account for that morning’s traffic. We shop using our tablets. In fact, to prove a point, I have dictated this very paragraph using my smartphone’s voice-to-text feature.

So no wheels are being reinvented when I say mobility is a big piece of the puzzle. But it is how you approach mobility that can make or break your digital strategy, and can truly help you accelerate the rate at which clinical trials take place.

First, it is critical for organisations to realise the importance of native mobility – that is, the ability to make any application for any process available on any mobile platform and on any device, straight out of the box. Without that capability, ideas for applications – with the best intentions of improving a portion of a clinical study, or helping a patient – are blanketed by uncertainties over how long it will take and how difficult it will be to make it available on mobiles. You must approach your applications with a 'build once, deploy everywhere' mentality.

It is also important to remember that any initiative undertaken to improve the clinical trial process is done in order to achieve some sort of business objective, satisfy a particular consumer requirement or meet regulatory standards. Whether it is creating tools to automate certain early-staged processes, like site onboarding or digitalising the gathering, analysing and response to participant feedback, it must be done in a way that serves the greater business ecosystem – rather than be thought of as IT solutions.

Collaboration


Increased collaboration is an omnipresent initiative in IT organisations, and in companies of all sizes and across all industries. A cooperation of high quality can help enhance the clinical trial process from end to end, beginning with study start-up through to participant engagement and monitoring.

An intuitive collaboration capability allows investigations to be completed faster, since most of the time required for an investigation is eaten up in the wait between steps – and rapid collaboration leads to faster decisions, reduced risk of improper payments and improved response to requesters and the parties they want to engage.

Especially now with change being the reality of the day, we have to be open to new ideas, new technologies and new ways of conducting business. And so, when it comes to traditional business process management (BPM) and case management solutions, forget what you know: the schemas you associate with these technologies are holding you back. Sure, BPM as a discipline is incredibly important, since managing process and information as effectively as possible is vital to organisational success. Particularly in case management, the statement “get the right people the right information at the right time” still rings true.

Just 10 years ago, enterprise technology had to be complex to be considered good. Smartphones did not exist. Social collaboration meant instant messaging. Workflow automation and enterprise portals were all the rage. Today, can you imagine a world without mobile connectivity – without the inclusive, social nature of modern technologies, and without the convergence of enterprise tech that integrates, leverages and manages multiple capabilities?

But, there is good news. To stay relevant, organisations can be navigated through the change. And, while transformation is never trivial, there are fundamental steps that can pave the journey. Some of the most recognisable brands, businesses and even government entities are well down this road. You can be too.


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Evjatar Cohen is an experienced pharmaceutical executive with an extensive background in developing global business portfolios, including new products, technologies and intellectual property. As Global Practice Leader for pharmaceuticals at Appian, he is responsible for client success and continued steady growth in licence revenues across all pharma clients. Evjatar previously worked for Catalent as Vice President of Global Innovation. He holds an MBA in Pharmaceutical Management, an MS in Biotechnology and a BS in Chemistry.
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