spacer
home > ict > Spring 2017
PUBLICATIONS

International Clinical Trials

ict
Spring 2017

   
Text
PDF
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.


 
view
download pdf
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.
 
view
download pdf
bullet
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.
 
view
download pdf
bullet
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.
 
view
download pdf
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.
 
view
download pdf

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.
 
view
download pdf

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.
 
view
download pdf
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.
 
view
download pdf
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.
 
view
download pdf

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.
 
view
download pdf
   
spacer
Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

BioIVT Introduces New Quality Management System to Maintain Highest Quality Biospecimens and Drug Development Research Services

BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it is introducing a new internal cloud-based Quality Management System (QMS), Master Control. This new standardized, ISO compliant QMS will help BioIVT manage documentation, auditing, supplier and customer accounts, and risk across all locations. It will consolidate and replace a variety of computer- and paper-based document control systems located at existing and newly-acquired BioIVT sites in the US, Europe and Asia.
More info >>

White Papers

Case Study: Cmed’s Mobile Data Management Solution

Cmed Clinical Services

The trial presented to Cmed was a randomized, double blinded, placebo and active controlled study to evaluate the cardiac safety of multiple doses of [study drug] in health volunteers. The pharmaceutical company, who were into the second year of development of a potential blockbuster compound for the treatment of chronic myelogenous leukaemia (CML), were requested by the FDA to design a trial to provide information on the cardiac safety of different dose levels of the study drug in healthy adult volunteers. The primary objective of the study was specifically to find the maximum tolerated dose before QTc levels became unsafe. All development of the compound was put on hold until the results of this study were submitted to the FDA and approval granted for the compound to progress into full development.
More info >>

Industry Events

Pre-Filled Syringes & Injectable Drug Devices Europe

16-17 January 2019, Copthorne Tara Hotel, London

SMi is proud to present their 11th annual European conference and exhibition, within the Pre-Filled Syringes series: Pre-Filled Syringes & Injectable Drug Devices Europe. The event will take place on the 16th-17th of January 2019, in London.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement