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International Clinical Trials

ict
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,
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News and Press Releases

Exploristics present the Welcome Organisation with Christmas Shoeboxes


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White Papers

BioT ULT Transporter

BioCision

The growth of biobanking, cell therapy, and complex biopharmaceutical therapies like cancer vaccines has created a strong need for products and processes to ensure the stability of temperature­-sensitive biospecimens. Proper collection, handling, characterization, packaging and shipping of these materials is critical, as poor sample handling impacts researchers working on discovery with patient samples, as well as clinicians treating patients with cutting edge therapies. This white paper describes in detail the BioCision BioT™ ULT Transporter, the first-of-its-kind dry ice-based portable cooling system that maintains a stable -75° to -50°C environment for over 24 hours on one charge of dry ice, enabling reliable handling and transfer of valuable temperature-sensitive biospecimens as part of a larger cold chain standardization process.
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Industry Events

Highly Potent Active Pharmaceutical Ingredients 2017

22-23 May 2017, Copthrone Tara Hotel, Scarsdale Place, Kensington, London, UK

The global market for Highly Potent Active Pharmaceutical Ingredients is currently on a growth fast track, largely driven by its major use in oncology for cancer treatment and more often in the form of ADCs.
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