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International Clinical Trials

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Autumn 2018

   
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REGULATORY
The GDPR Impact on Data Management

Reviewing the Rulebook

Kaia Koppel and Agnieszka Felicjanczuk at KCR reflect on the implementation of the General Data Protection Regulation and speak about the consequent impacts that are beginning to show themselves.
 
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Regulatory & Business Practice
Developing a Pharmacovigilance Presence in Japan

Planning and Execution

A great deal must be be considered when expanding and developing a pharmacovigilance presence in Japan. The team at PPD and PPD-SNBL delve into the intricacies of this essential challenge.
 
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TRIAL MANAGEMENT
 
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Clinical Trial Outsourcing
Outsourcing and Vendor Management

Does Size Matter?

Heike Schön at LUMIS International reviews outsourcing during the early stages of clinical trials, providing an insight into what to look for when wrestling with budgets and resources.
 
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eCLINICAL
Digital Technologies in Clinical Research Networks

Clinical Connectivity

Andreas Walter and Le Vin Chin at Clinerion discuss modern technologies and how they are being utilised across the clinical research industry to speed up processes and deliver higher quality results.
 
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Ethics & Risk Management
Pharmacovigilance in the EU

Quality Upkeep

Some complex requirements must be met to establish a pharmacovigilance system, particularly when it comes to products and patient safety. David Hukin at Quanticate explains more.
 
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Approvals for Gene-Based Therapy

Navigating Through Uncharted Waters

Medical advancements are commonplace in gene-based trials, but several challenges need to be overcome. The team at Worldwide Clinical Trials explore the safety and ethical side of these specific trials.
 
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Cancer Therapeutics
Transforming Cancer Outcomes with Real-World Evidence

Capturing Cancer Evidence

With the ever-evolving measures surrounding patient-reported outcomes, providing the best services to patients is critical, as explained by Dr Tim Williams at My Clinical Outcomes.
 
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Trial Design
Q&A: An Integrated Approach to First-In-Human Trials

Clinical Complexities

Torkel Gren at Recipharm and Anders Millerhovf at Clinical Trial Consultants spoke to ICT about the differing complexities of first-in-human trials and advise on how to craft an effective journey to market.
 
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Unifying Clinical Operations

Streamlining Start-Ups

Veeva Systems’Rik Van Mol describes how clinical leaders across the industry are beginning to understand the benefits of unification for clinical operating environments and how strategies are being attained.
 
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Q&A: Adaptive Trials

Modifying Methods

Dr Sy Pretorius at PAREXEL offers his insight to ICT about how the utilisation of adaptive trial design can improve data collection, as well as increase the chance of overall trial success.
 
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Patient Recruitment and Retention
Patient Travel Assistance

Talking Travel

Hannu Koski and Rob Laurens at BBK Worldwide take a detailed look into the role that transportation can play to ensure patient retention and satisfaction across clinical trials.
 
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End Point
End Point

The Imminent Exit

ICT’s Editor, Dr Graham Hughes, looks ahead to the UK’s exit of the EU and what it may mean for clinical trials and medication in the following year.
 
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Published quarterly in
February, May,
August, and November

News and Press Releases

Northway Biotechpharma enters into Development and Manufacturing Agreement with Synklino

Vilnius, Lithuania, and Copenhagen, Denmark – December 18th 2019 – Northway Biotechpharma, a leading biopharmaceutical Contract Development and Manufacturing Organization (CDMO), and Synklino, a company active in developing a therapeutic protein based therapy as treatment for cytomegalovirus (CMV) infection, announced today that they entered into a Development and Manufacturing Agreement for the recombinant fusion protein SYNx, which Synklino aims to bring into clinical trials.
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White Papers

Sourcing Commercial Drugs for Clinical Trials: US vs. EU Understanding the Differences

Myoderm

Sourcing commercial drugs for clinical trials is a dynamic process. There are many factors to consider: single source or regional sourcing, strategy, price, supply availability, lead times, and documentation are just a few. In the past, there were fewer clinical trials that required commercial drug sourcing, so demand was not as high. Today, the demand for commercial drugs in clinical trials has greatly increased and, as a result, inventory is tighter, orders are monitored more closely by manufacturers, and lead times have increased. This report highlights the key differences in sourcing from the US and EU.
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Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
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