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home > ict > Autumn 2018

PUBLICATIONS

International Clinical Trials

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.

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.

TRIAL MANAGEMENT

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Published quarterly in
February, May,
August, and November

News and Press Releases

3P Biopharmaceuticals initiates partnership with American Biotech Zhittya for Parkinson’s disease treatment

3P and Zhittya began their relationship at the beginning of 2019 with 3P being selected as the CDMO to transfer the process for scaling up and performing cGMP manufacturing for clinical studies. After successfully achieving transfer of the process, 3P anticipates manufacturing of the first cGMP batch by the second quarter of 2020.
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White Papers

Utilising Big Data to Produce Faster and Cheaper Clinical Research

Medical Research Network (MRN) Limited

Recruitment and retention of patients remains the major challenge to ensuring trials run as fast as possible and give them the statistical power they are designed to produce. This is not just about getting better any more - but about stopping the deterioration of these metrics in modern clinical trials.
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Industry Events

Clinical Operations in Oncology Trials West Coast

21-22 April 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.
More info >>

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