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International Clinical Trials

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Spring 2017

   
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REGULATORY
End Point

Getting Better

Dr Graham Hughes
looks for real change across the last 20 years of the pharma industry and proposes that the sector needs to start thinking outside the box in order to evolve.
 
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Regulatory & Business Practice
eCRF and GDPR Compliance

Rules and Regulations


Those running clinical trials will have another set of regulations to keep in mind come May 2018, as the GDPR on data protection comes into effect across the EU. Christer Nilsson at Trial Online deciphers what action is needed to handle the impact on businesses, trials and software.
 
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Standardised CTMS

Strength through Collaboration


James Batchelor at the University of Southampton promotes research teams coordinating both nationally and internationally, in safely changing routine standards of clinical care to improve patient quality of life.


 
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TMF Survey

Built with Purpose

Rik van Mol
at Veeva Systems considers the benefits of going digital, from cost savings to enabling faster study start-ups, as CROs blaze the trail of moving from paper to electronic trial master file applications.
 
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Clinical Trial Management
Rare Disease Trials

Odd One Out


The very nature of rare diseases means they pose an intimidating challenge for those creating pharmaceutical development programmes. Jeffrey Zucker at Worldwide Clinical Trials faces down the aspects of such studies that make it so difficult to recruit and retain participants.
 
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data management & statistical analysis
Data Management & Pharmacovigilance

On the Lake


Sudeep Pattnaik at ThoughtSphere tackles the growing complexity of trials with the help of data lakes. These storage repositories facilitate cross-examination across different systems, offering great benefits for those who safely collect and analyse their results regardless of the source.
 
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Platform as a Service

Data on Trial


Steve Canham at Canham Information Systems and Will Crocombe at RISG Consulting argue that increased transparency is key to improving PaaS infrastructure in clinical research, and review what steps providers and consumers will need to take for external hosting provision of trial data.
 
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Business Practice
Translating Medical Terminology

Language Barriers


Misinterpretations can be hazardous to patients. Jack Cater at Corporate Translations lays out the options for medical translators faced with unknown terminology or words with no direct analogue.
 
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Patient Recruitment and Retention
Patient Enrolment

Needle in a Haystack

Small patient population and medical uncertainties make it difficult to recruit participants for rare disease trials. Dr Scott Treiber at Chiltern reveals how conducting such studies can offer many unique advantages.
 
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Recruitment Strategies for Dermatology Trials

Reaching Out


Darcee Duke Strube and Milena Reckseit at Novella Clinical explain how online marketing methods are useful when recruiting patients for dermatology trials, as the traditional methods for attracting an audience are eclipsed by the digital era.
 
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Globalisation and Patient-Centric Language

Turn of Phrase


Communication is key to boosting retention rates and improving ties between researchers and participants. As more and more clinical trials are being outsourced to countries with different cultures and languages, Alicia Lewis at MD Group highlights the importance of competent translation.
 
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Interview
Q&A: Linguistic Challenges

Word for Word


In this question and answer feature, SeproTec Multilingual Solutions’ Juan Julián León tells ICT about the qualities needed for excellence in pharmaceutical translation, as well as the innovations and challenges facing his specialised field.
 
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

Digital Health and Wearables

• Datwyler uses strategic partnerships to develop new solutions in the fields of wearables and digital health. • The company’s health care offering is always designed towards improving the comfort of patients during treatment. • The product portfolio and innovative healthcare solutions will be presented at several important trade fairs of the medical sector.
More info >>

White Papers

7 Common Myths about QP Training Debunked: A Guide for Senior Managers

RSSL

The role of the Qualified Person (QP) in the pharmaceutical industry is mandated by law (Directive 2001/83/EC, Directive 2001/20/EC, UK SI 2012/1916, UK SI 2004/103). Every holder of a relevant Manufacturers Authorisation (human and veterinary) must have at least one QP; without one, no batch of medicinal product can be certified for release for sale.
More info >>

Industry Events

PDA Parenteral Packaging 2019

19-20 March 2019, Hilton Molino Stucky, Venice, Italy

PDA Europe’s Conference has become a must-attend event for all professionals in the Parenteral Packaging arena. Join us in Venice in March 2019 to continue and further deepen scientific advancements and our ongoing professional discourse of latest on primary packaging technologies and business trends. This conference and the accompanying exhibition address quality of components and cont­ainers, container closure development and integrity testing as well as aspects of processing, product distribution and storage.
More info >>

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