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International Clinical Trials

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Summer 2020

   
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Features
The Digital Race for Early Detection and a Cure

Ijah Mondesire-Crump and Rahul Mahajan at nQ Medical

The urgent need for disease-modifying therapies will require further adoption of data-driven digital solutions for acceleration of development timelines with powerful, more efficient clinical trial designs
 
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Developing the Optimal Recruitment Strategy

Gabbie St. Remy at CSSi

There are many factors that can lead to challenges in recruitment, and often trials struggle to meet enrolment milestones on time or on budget, so how can recruitment strategies be optimised to maximise enrolment?
 
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Therapeutic Focus: Oncology
Resilience and Risk: Breaking Ground in Oncology

ICT sits down with Andreas Voss at Swiss Rockets Ltd to discuss the oncological landscape, where he sees research heading, and ways in which the industry needs to grow to improve treatment options available to patients
 
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Bringing the Trial to the Patient by Leveraging Electronic Technology

Karen A Gammon and Nikki Luttrell at Linical

Decentralised ‘virtual’ clinical trials in oncology are becoming the 'new normal' with the help of technology, but patient-centricity needs to remain the focus in this changing climate
 
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Regulatory Challenges in Global CAR T Cell Therapy Development

Dr Brian Marks BSc, DC, and Ashley Jones MSc at Premier Research

When exploring the complex and rigorous regulatory landscape for CAR T cell therapies, sponsors may encounter challenges in their efforts to bring products to market
 
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Surviving Isn’t Thriving

Jacqui Whiteway and Missy Hansen at PRA Health Sciences

With difficulties in research for paediatric cancer treatments, the RACE for Children Act brings hope for curing childhood cancer, and saving the lives of our most vulnerable members of society
 
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Regulatory Affairs
Improving the Chances of EU Approval

Lisa Pascoe and Lucy Gluyas at PharmaLex

Managing regulatory approvals can be daunting, but taking steps to ensure success with early-stage input from regulatory teams inevitably builds a solid relationship with the competent authority assessors

 
 
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The Impact of the EU MDR on Medical Device Supply Chains

Chad Reynolds at Maetrics

The new EU MDR deadline has been postponed to 2021, giving pharmaceutical and medical device companies extra time to get prepared for the many changes they will have to instigate
 
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Speeding Clinical Trial Processes Through Greater Agility

Romuald Braun at Amplexor

Clinical trials are under the spotlight as the healthcare sector seeks to introduce innovative treatment as quickly as possible in the current health crisis. IT teams and suppliers can help companies to be more agile and responsive to changing market conditions
 
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Exploring Common Questions for Your EU Drug Product Launch

Brian Lavery at Almac Group

With changing regulations and complex requirements, there are a number of regulatory submission strategy considerations that must be accounted for when launching a product in the EU
 
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Preserving Trial Integrity During a Pandemic

Karen Ooms at Quanticate

In the face of COVID-19, clinical trials have a greater need for flexibility, but they still shouldn’t affect patients’ safety or compromise study validity
 
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Integrated IT Systems and the Challenge of Globalisation

Lars Behrend and Michael Sigmund at SSS International Clinical Research

Fast-moving information is key if mid-sized CROs are to keep up with their larger competitors, and the best way to do this is with an integrated clinical trial management system
 
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A Golden Opportunity… But Not a Silver Bullet

Barry Balfe at ICON

Pharmaceutical companies are increasing their functional service partnership expenditure at a rapid rate, but key considerations in selecting and executing the FSP model are being overlooked
 
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The New York Hot Zone

EPC sits down with Dr Christina Brennan at Northwell Health to discuss the running of COVID-19 treatment trials during the current pandemic
 
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Data Management
Data Sharing: Safely Facilitated Through Shared Responsibility

Oli Cram at Elsevier

Not everyone is willing to share, so how can researchers, institutions, and drug manufacturers meet their ethical obligations, without jeopardising their commitments to compliance, copyright, and privacy protection?
 
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Outcome Solutions in Medical Research

Dr Bill Byrom, Dr Denis Curtin, Dr David Daniel, Dr Alan Kott, and Dr Gary Sachs at Signant Health

By using a hypothetical protocol in CNS clinical research, it is possible to illustrate new approaches to common real world study challenges that research teams face
 
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The ‘New Normal’ Requires Modernised Operations

Life science companies that adopt clinical trial technologies to meet immediate COVID-19 challenges are turning industry disruption into clinical trial management transformation
 
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The Home-Working Data Manager

Jonathan Hart-Smith at CK Group

Times are changing, as are the working habits of data managers. With uncertainty abound, the question on everyone’s minds is – what happens next?
 
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The Importance of CDMS in the Clinical Study Process

Rohit Jain and Rebecca Lorenzo at Axtria, Inc.

Implementing and executing a clinical data management system provides a foundation for error-free data collection to meet rapidly advancing technological and business needs with improved accuracy and efficiency
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

Janssen Announces Phase 1 Results for Bispecific Antibody Amivantamab in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harbouring Exon 20 Insertion Mutations

BEERSE, BELGIUM, May 18, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced results from the Phase 1 CHRYSALIS study evaluating amivantamab (JNJ-6372) in the treatment of patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations.[i] Amivantamab is an EGFR and MET-targeted bispecific antibody, which targets activating and resistance EGFR mutations, and MET pathway activation.[ii],[iii] Investigators assessed efficacy using overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), duration of response, as well as the safety profile of amivantamab,1 which were the basis of the U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation granted earlier this year.[iv]
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White Papers

The Importance of ADCC in Assessing Clinically Relevant Differences

Sartorius Stedim BioOutsource Ltd

Biosimilars have caused a revolution in the development of biologic drugs. The model for biosimilars is a combination of speed to market and low cost; these are fundamental to any biosimilar development project. The biosimilars pathway to approval is not always without difficulty, biosimilars are still relatively new, and as each new applicant is reviewed we are learning more and more about these molecules.
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Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>

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