International Clinical Trials |
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A Human-Centred Approach to Diverse Patient Recruitment and Engagement
Zoltan Varga at IQVIA
Patient-centred approaches are vital to keeping clinical research moving for those in need.
However, despite efforts, sponsors still struggle to recruit diverse populations in a truly
representative way to help studies deliver safer and more effective new treatments
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Harnessing the Power of Technology to Enhance the Patient Experience and Improve Trial Recruitment and Retention
Paul O’Donohoe at Medidata,
a Dassault Systèmes company
Patient burden in clinical trials remains one of the biggest challenges for the life science
industry. By focusing on the issues patients face, dropout rates can be reduced, and participants
can have a more positive trial experience
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It’s All in the Details
Craig Mooney at Calyx
Direct-to-patient shipments of clinical trial drugs help ensure participants can conveniently
take part in trials. There are, however, many considerations to take into account when designing
a decentralised or hybrid trial with this dispensation model
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Myonex’s Integrated Clinical Trial Supply Solution
With fresh offerings and a new world-class headquarters, Myonex finds innovative ways to help
their customers, especially biopharma companies, take time and costs out of their clinical trials
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The Need for Adaptive Trial Design in Oncology Studies
Kathleen Greenough at 4G Clinical
The changing nature of clinical trials means studies in all therapeutic areas are rising in complexity. But even with thousands of pharmaceutical trials currently underway across the globe, oncology trials are still presenting more difficulty to sponsors due to size and numerous changes in study protocols
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Disruptive Changes
for a Better Clinical
Research Future
Hans-Juergen Arens at Frenova Renal Research
The SARS-CoV-2 pandemic highlighted that the industry could change in response to outside
pressure. However, change can be volitional instead of reactionary, which could better the
industry before the next crisis
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Why Biotechs Lack Biospecimens With Adequate Provenance
Robert Hewitt at Biosample Hub
The UK’s biotech potential has been dominated by large pharma companies, and small biotechs
are being held back by lack of access to fully documented biospecimens
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The FDA, EMA, and PMDA Questions: How to Respond During Review of CTD Submission Dossiers
Douglas Fiebig at Trilogy Writing & Consulting
After submission of the application dossier, it is essential that the team that prepared the
application does not dissipate. Instead, it should prepare for the sprint that begins
after the questions from the regulators arrive
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Coming to America – Successfully Tackling the FDA Landscape
Dr Kamali Chance and Dr Tracy Goeken
at Linical Americas
Often the regulatory guidelines in other parts of the world differ significantly. However, by engaging experienced consultants or through interactions with the FDA, sponsors learn what will be needed to register their drug product in the US
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Post-Brexit:
MHRA Submissions
Alok Patel at TMC Pharma Services Ltd
The UK’s exit from the EU has thrust the MHRA into the spotlight for many companies seeking
to move their products through this regulatory minefield. From an objective perspective, one
company describes its experience in navigating through the submission process
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What Is Leadership in a COVID-19 Era?
Claire Pegg, Trust Lead Research Nurse, and Ross Downes at the NIHR
Two leaders from the NHS and National Institute of Health Research (NIHR),
Claire Pegg and Ross Downes (overleaf), share their insights into what this
pandemic has meant for their teams, their styles of management, and what
could be in store for mentors in the future
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Process-Focused Production
Campbell Bunce at Abzena and
Gerrit Hagens at BioXpress Therapeutics
Through key partnerships, biosimilar drug developers benefit from an integrated
approach to production spanning the range from design consultancy, cell-line and
process development, through to clinical and commercial GMP manufacture
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The Future of Data and Document Management
Remco Munnik at Iperion, a Deloitte company,
Peter Brandstetter at Accenture, Caroline
Masterman-Smith at Syneos Health, Steve Gens at
Gens & Associates, and James Kelleher at Generis
The way life science companies generate, manage, and store documents and data is
changing irreversibly – as it must if teams are to operate in more agile and dynamic
ways and keep pace with the demands of industry regulators
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Why Partnerships Are Key to Overcoming Talent Acquisition Challenges
Eoin McAtamney at Ashfield Engage, part
of UDG Healthcare, and Paul Burden at
ADVANZ PHARMA
Collaboration with expert partners is crucial to building and delivering an industry-leading
pharmaceutical talent acquisition programme
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New Approaches for Rare CNS Drug Development
James Vornov, Michelle Petersen,
and Richard Scheyer at Medpace
The central nervous system is hit by a number of disorders and diseases, treatments
for which are benefiting patients in more ways than one
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Personalised
Medicine for Psychiatry
Requires Novel
Trial Designs
Dr Hans Eriksson at HMNC Brain Health
Neuropsychiatric disorders are some of the most complex in healthcare, especially
when it comes to depression. Designing a trial for these vulnerable patients involves careful
and complex protocols
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The Growing Potential of Neurological Biomarkers as Surrogate Endpoints for Accelerated Drug Approval
Peter Schueler at ICON
In many of the devastating diseases affecting the central nervous system, researchers are
hoping to pinpoint the signs that can lead to specific patients, and the specific treatments
that can alleviate them
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Embracing the Future of Hybrid Trials
Fred Martin at Medrio
In the resulting digital boom resulting from the global pandemic, trials have become more virtual. However, a one-size-fits-all approach isn’t always the solution, and many researchers are opting for a design incorporating the best of both worlds
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A Vision for Real-World Data Technology
Douglas Drake at Clinerion Ltd
To enable faster access to innovative medical interventions for patients and physicians, part of
the strategic approach must be unlocking the full scope of usable, useful information from patient
electronic health records (EHR) to generate productive real-world data
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Driving Clinical Data
Value with Data Science
Richard Young at Veeva Systems
To capitalise on the digital boom within pharma, companies need to steer their focus towards
forming key insights from quality research data, with skilled data teams at the wheel
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An Intelligent Approach to Smarter Data Cleaning
Helen Smith at PHASTAR
Using an intelligent approach to data cleaning delivers the primary aim of driving efficiency.
Close collaboration between data teams can help achieve this goal, with specialised expertise
from all departments coming together
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So, You Want to Run a Decentralised Clinical Trial…
Mike Hutton, Ivan Hanley, and Matthew
Lowrie at Almac Clinical Technologies
Interactive response technology is proving essential to the clinical trial industry, helping
businesses keep up with eClinical trends in a variety of traditional and modern trial designs
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