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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.

Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

Protagen Protein Services and BioAnalytix Merge to Create Global Analytic Service Partner for Biopharmaceuticals

Protagen Protein Services GmbH (PPS), a full-service contract research organization (CRO) in protein analytics and BioAnalytix Inc., a Cambridge (MA)-based specialized provider of advanced analytics in biopharmaceutical development announced today a merger that will transform the combined company into a leading global analytic services provider for the biopharmaceutical industry. Today’s announcement creates a best-in-class partner for biopharmaceutical companies worldwide to benefit from the most advanced, integrated and complete analytic services capabilities in biopharmaceutical development, from clone selection through drug approval to commercialization.
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White Papers

Clinical Trials in Russia Orange Paper: 1st Quarter 2014

Synergy Research Group

In summary, Russia remains a very popular geography for local, regional, and global pharmaceutical companies to conduct clinical trials. Sponsors mention the following reasons for conducting studies in Russia: 1. Fast patient enrollment due to the centralized medical infrastructure. 2. Nearly 100% patient retention 3. GCP trained and certified Investigative Sites generating high quality data 4. Low cost: Average per patient cost is 60% to 70% below US and European prices due to the low cost of Investigators and the high concentration of patients in therapeutically aligned medical centers
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Industry Events

ASGCT 22nd Annual Meeting

29 April - 2 May 2019, Washington Hilton, Washington, D.C

The 2019 ASGCT Annual Meeting is expected to be the largest in Society history, eclipsing the mark set by the 2018 meeting just last year. Join more than 3,500 researchers, clinicians, advocates, and industry leaders in discovering the latest science and technology surrounding gene and cell therapy.
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