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| home > ict > Winter 2021 |
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 PUBLICATIONS |
International Clinical Trials |
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Seek a System that Makes
the Complex, Simple
Sylvain Berthelot and Malcolm Morrissey at Calyx
Successfully designing an IRT for adaptive and platform trials eases the burden on researchers
and can speed up trial processes, and alleviate the risks associated with randomisation.
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Won’t Someone Think of
the Children
Douglas Cookson at MRN
For too long children have been forgotten in clinical research, but with the flexibility of
decentralised trials paediatric patients can get the lifesaving treatments they need.
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Cancer Clinical Trial
Eligibility Criteria
Dr Martine Dehlinger-Kremer and Dr Mark
Sorrentino at PRA Health Sciences
When can, and should, the paediatric population be involved in cancer trials? For the longest time,
our young and vulnerable have had to struggle to find viable treatments; now, with new guidance
and legislation, their lives could be made easier.
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Innovation in Paediatric
Trials: Conducting Study
Visits at Home
Jamie Wardynski, Kumar Ilangovan, Jordan
Godwin, and Betsy Reid at Paidion Research
Clinical trials regularly struggle with adherence and recruitment, especially those involving
children. However, decentralising clinical trials and incorporating more home-care could help
solve these problem.
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Embracing a Functional Service Partnership Model for Rapidly Growing Biotechs
Timothy King and Jan Maarten Kroodsma at PPD FSP
A tailored functional service partnership model can provide biotechnology companies on
the cusp of significant growth, with the expertise and flexibility they need for successful
development and deliver.
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A Call to Attention
Mark Toshner at the University of Cambridge
After a tweet sparked the public’s interest, Dr Mark Toshner at the University
of Cambridge realised that his voice mattered, and that ordinary people
just wanted answers. EPC sits down with the academic, and discusses the
importance of communication in this pandemic.
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Automating Regulatory
Data to Drive Digital
Transformation
Duncan van Rijsbergen at Iperion
Now, more than ever, enabling products to be brought to market without delay
is essential – automating these processes during the post-authorisation stage
can help streamline these operations and cut out human error.
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Pharmacovigilance in the
Post-COVID-19 World
Thomas Leigh at Covance
While the rollout of the vaccines has begun, the pharmaceutical industry must
continue to evolve in the management of potential safety signals brought about
by the pandemic.
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Data Collection During
the COVID-19 Pandemic
and Beyond
Deepu Joseph at Quanticate
In this pandemic, we’ve seen technology expedited enormously in order to
keep trials running and patients receiving treatment. One of the primary areas
of innovation has been in our data collection.
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Compelling Advantages of Creating a PatientCentric Supply Chain
Nina Vas at Marken
The evolving clinical research industry must rely heavily on an established supply chain strategy.
High-quality, consistent services improve turnaround time, save cost, and decrease risk for
manufacturers, sponsors, and patients.
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The APAC Advantages
Daniel Gao at Catalent Pharma Solutions, Shanghai
The COVID-19 pandemic has caused numerous catastrophic supply chain disruptions all over
the world, including where it began, in Asia. However, with experienced support, those
problems can be nullified.
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Digitalisation of
Clinical Trials
Nathan Kohner at Almac
Labelling has an important role in driving fundamental process efficiencies to safeguard patients
in clinical trials and deliver increased return on investment.
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Forecasting for Success
Sarah Jane Hayward and Slava Shulov
at PCI Clinical Trial Services
Anticipating problems with stock and preparing for potential logistical complications are
essential aspects of clinical trial management. Forecasting must take into account many aspects
of the supply chain to avoid costly hold-ups.
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No Room for Error
Radha Krishnan at Avantor
With multiple COVID-19 vaccines being prepared for mass distribution, there are various
challenges that working at speed brings to maintaining sample validity in critical vaccine
development.
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Fast-Tracking Supply in a
Patient-Centric World
Richard Adams at PRISYM ID
At the end of an unprecedented 12 months, a brighter legacy may yet emerge from the dark shroud
of COVID-19, with four big lessons from a pandemic year.
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The Hundred-Year Quest
Dr James Shapiro at the University of Alberta
ICT speaks with Dr James Shapiro, Canada Research Chair in Transplant Surgery and Regenerative
Medicine at the University of Alberta, about his work to cure one of the most prevalent diseases of
the modern age.
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A Long Road Ahead
ICT interviews Professor Chantal Mathieu at the INNODIA project about her research to prevent
Type 1 diabetes, and the impact of COVID-19 on those efforts.
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Long-Term Gene Therapy Follow-Up: Patient Considerations
Hanna Wide and Anne-Marie Nagy at Premier Research
When developing a long-term follow-up strategy for gene therapy trials, safety is the main
concern, closely followed by the patient perspective. Digital technologies and monitoring have
proven essential to this, easing the burden on the patient, and providing accurate, time-saving
methods of data management.
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The Future of Rare
Disease Therapies
Dr Matthew Klein at PTC Therapeutics discusses gene therapies, the impact
of COVID-19, and regulatory processes with ICT.
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The Precision
Paradigm
Erik Gatenholm at Cellink
From cosmetic treatments through to specific tissues and organs, 3D bioprinting is set
to become a hugely important method for patients worldwide, but it isn't without
its difficulties.
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News and Press Releases |
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4G Clinical Ranks No. 28 on Inc. Magazine’s List of the Northeast Region’s Fastest-Growing Private Companies
WELLESLEY, MA, MARCH 15, 2022 – Inc. magazine announced that 4G
Clinical is ranked 28th on the third annual Inc. 5000 Regionals:
Northeast list, recognizing the company’s 518% growth in a two-year span
between 2018 and 2020. This prestigious ranking of the fastest-growing
private companies based in Connecticut, Massachusetts, Maine, New
Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont
represents a unique look at the most successful companies within the
Northeast region’s independent small businesses.
More info >> |
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White Papers |
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Tightening Your Supply Chain Against Counterfeits
World Courier
As today’s global pharmaceutical supply chain grows increasingly longer and more complex, each link provides added opportunity for counterfeiters.
While pending regulatory changes promise to tighten the supply chain with respect to production and distribution entities and new packaging technologies will make the identification of counterfeit products easier, the logistics of global distribution remains a weak link.
How can the pharmaceutical shipper ensure the security of the supply chain over thousands of miles and extended periods of time when the product is no longer in his possession?
More info >> |
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