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International Clinical Trials

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Winter 2021

   
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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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Paediatric Trials
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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Clinical Trial Packaging and Logistics
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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Therapeutic Focus: Diabetes
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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Personalised and Precision Medicine
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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Published quarterly in
February, May,
August, and November

News and Press Releases

MyMD Pharmaceuticals Announces Issuance of U.S. Patent for Synthetic Cannabinoid Compounds for Treating Neuroinflammatory and Neurodegenerative Diseases

MyMD Pharmaceuticals Inc., a clinical stage pharmaceutical company committed to extending healthy lifespan by focusing on developing two therapeutic platforms, today announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,085,047 titled “Synthetic Cannabinoid Compounds for the Treatment of Substance Addiction and Other Disorders.”
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White Papers

Cold-chain Bioprocessing Readiness: Mitigating Risk and Protecting Pharmaceutical Products

Entegris

The pharmaceutical industry is migrating rapidly toward a world where drugs, vaccines, and specialized therapies are available on demand to patients anywhere around the globe. Whether accelerating clinical trials to bring new drugs to market or devel oping biosimilars to give more patients access to established commercial drugs, small and midsize production facilities stand to benefit from growing demand. To do so, however, they must be prepared to handle a broader mix of products and increase throughput without sacrificing safety or reliability, while at the same time keeping life-saving medica tions affordable. Such challenges become more difficult when working with products that must be stored and shipped in a frozen state.
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