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| home > ict > Spring 2017 |
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 PUBLICATIONS |
International Clinical Trials |
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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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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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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 & 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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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 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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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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News and Press Releases |
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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 >> |
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White Papers |
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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 >> |
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Industry Events |
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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 >> |
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