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International Clinical Trials

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Autumn 2021

   
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Patient Recruitment and Retention
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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Features
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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Regulatory Affairs
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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Therapeutic Focus: Neurology
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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eClinical Trends
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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