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International Clinical Trials
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ICT: It is essential that clinical trial logistics are carried
out in such a way as to optimise client investment. This involves
managing time- and temperature-sensitive products to deliver potentially
lifesaving treatments. How does World Courier ensure that drugs reach
their destinations unharmed?
Volker Kirchner: World
Courier is deeply involved with each shipment in the clinical trial
process, knowing that the successful outcome can directly affect a
patient’s health and life. Therefore, the safety, integrity and
successful delivery of every shipment is of paramount interest to us.
Before each project, we work closely with clients to gain a full
understanding of their material requirements. We then select a solution
comprising shipment routing, documentation and temperature-controlled
packaging, which ensures that the drugs arrive where they need to be,
when they need to be, and at the temperature they should be – without
fail.
Can you tell us more about the role of packaging in the cold chain, and what kind of solutions are currently on the market?
As
much of the material sent in the course of trials is
temperaturesensitive, packaging plays a critically important role in the
entire logistics process. There is a plenitude of different packaging
systems and solutions available – each with strengths and weaknesses in
specific situations – so selecting the best option for a certain drug is
a challenging matter, but one that the success or failure of a shipment
can easily hinge upon.
World Courier has maintained an
intensive overview of the multitude of different solutions available,
and even undertaken the task of creating its own temperature control
packaging solutions when none of sufficient performance existed on the
market. Our specialists are able to use their knowledge and overview of
the packaging to assess the best fit for a specific shipment or entire
project, required transport temperature, duration of transport,
infrastructure available at all points along the way, and possible risks
during transit, such as strikes and natural disasters.
With
this knowledge and experience, the question of whether to use an active
or passive container solution, a polystyrene box with dry ice or a dry
shipper, a lightweight composite box with water-based gel packs, or a
robust vacuum insulated shipper with high-quality phase change
materials, can be analysed and solved in a way that is the best answer
to the individual shipping challenge at hand.
How does World Courier guarantee that strong relationships with sponsors, CROs, laboratories and site personnel are maintained?
In
our experience, we have come to learn that communication is everything.
Offering standardised, ready-made solutions and trying to apply them to
very special shipments alone will not result in success. That’s why
in-depth communication is so essential for a successful transport
completion. Sponsors, CROs, laboratories and site personnel are all
aware of the facts about the product, origin, destination and regulatory
requirements which are critical, but only through communicating with
all stakeholders, and thereby gaining an intimate knowledge of the
project, can we understand enough to guarantee success. With that
success through communication, strong relationships can be forged. World
Courier places strict emphasis on trust.
How does your company ensure that organisations continue to have faith in the services you provide?
Put
simply, “the proof is in the pudding”. Claiming to be the most trusted
speciality logistics company in the world is not the beginning of the
path to success, but the outcome of it. When we partner with the
pharmaceutical industry to understand their logistical needs, and
create, innovate and test customtailored solutions to meet those demands
and ensure that every single detail is met to complete satisfaction,
the end result is invariably trust. That is the single most important
currency with which we are paid for our dedication and diligence, and it
is the currency that allows us to innovate even better and more
ambitious solutions to meet the logistical challenges of tomorrow.
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News and Press Releases |
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SHIONOGI’S NOVEL ANTIBIOTIC, FETCROJA® (CEFIDEROCOL), HAS BEEN SELECTED BY UK’S NICE / NHSE&I AS PART OF AN ANTIMICROBIAL SUBSCRIPTION STYLE REIMBURSEMENT MODEL
The National Institute for Clinical and Health Excellence (NICE) and the National Health Service England and Improvement (NHSE&I) have recognised the potential of Shionogi’s innovative antibiotic, cefiderocol, and selected it for inclusion in this pilot reimbursement model which ‘de-links’ payment from volume of use
Shionogi recognises the UK’s leadership role in introducing this first fully ‘delinked’ pilot reimbursement model, which is an important step in making the market for novel antibiotics more predictable and sustainable; we strongly believe in the introduction of further suitable pull incentives in order to help stimulate the antimicrobial development pipeline
Fetcroja® (cefiderocol) is indicated for the treatment of infections due to aerobic Gram-negative bacteria in adults with limited treatment options1
Antimicrobial resistance (AMR) is a major health burden which results in over 700,000 deaths globally2 and 5,000 deaths per year in the UK3 from an infection with multidrug-resistant bacteria and this is predicted to kill 10 million people every year globally by 2050, unless action is taken2
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The Emerging Use of Social Media in Orphan Disease Drug Research
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