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International Clinical Trials
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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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News and Press Releases |
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Cobra Biologics and the Karolinska Institutet collaborate to develop COVID-19 vaccine
Keele, UK and Matfors, Sweden, 30 March 2020: Cobra Biologics (Cobra), an international CDMO for biologics and pharmaceuticals, and the Karolinska Institutet (KI), one of the world’s leading medical universities, today announced they have been awarded €3 million emergency funding by Horizon 2020 for research and development, and phase I clinical trial testing of a DNA vaccine against COVID-19, as part of the OPENCORONA consortium to support global efforts tackling the pandemic. Partners in the consortium also include Karolinska University Hospital, Public Health Authority (FoHM), IGEA, Adlego AB and Giessen University.
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White Papers |
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Six Strategies to Stretch Your Limited Drug Supply for Clinical Studies
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Bringing a new drug to market can be a heavy financial burden on any pharmaceutical company. It has become even more burdensome over the last several years as the industry pushes the boundaries of innovation. This is because newer, often more-complex therapies not only increase risk in drug development but also drive costs even higher. A recent analysis of the investment needed to develop a new prescription medicine shows the total cost can be as high as $2.6 billion (1). That number becomes even more staggering when you consider the fact that only about 12 percent of drug candidates that make it to Phase I testing are eventually approved by the FDA (2). The investment companies lose as a result may be too devastating to their bottom line to ever recover.
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Industry Events |
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Outsourcing in Clinical Trials Europe
26-27 October 2020, Paris, France
Arena International are delighted to announce the return of Outsourcing
in Clinical Trials Europe. Part of our global series of events, this
flagship show will attract the leading clinical professionals from
across Europe. The 10th Annual event will be hosted in Paris.
More info >> |
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