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| home > ict > Winter 2017 |
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 PUBLICATIONS |
International Clinical Trials |
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Editor’s Comment
With a wide range of topics from patient recruitment and retention to pharma after Brexit, there is a lot to discover in ICT February. Editor Dr Graham Hughes reflects on the most pressing matters.
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Brexit and the EU Clinical Trials Regulation
Business as Usual?
In light of Brexit, SynteractHCR’s Dr Martine Dehlinger-Kremer discusses the EU’s new Clinical Trials Regulation and how the pharma industry could be affected.
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Brexit and Clinical Trials
Life After Brexit
Dr Laura Brown at LB Training and Development contemplates the changes that the clinical trial landscape is set to encounter after the historic Brexit result. There will undoubtedly be some difficulties along the way, but the UK will also be presented with some new opportunities.
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IT in Drug Development
Weave the Threads
Constantly changing regulations create difficulties for companies in getting their products to market faster. In order to accelerate drug development, Appian’s Evjatar Cohen suggests that achieving a single source of truth could be key.
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End Point
Smaller World, Bigger Challenges
ICT Editor Dr Graham Hughes reports on the dramatic decrease in approved drugs since 2010, with one potential solution being the use of new chemical synthesis software.
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Primary Care
Reality Check
CK Aspire’s Julie Millar, Gaynor Mates and Louise Doyle assess the role of the research nurse in real world studies for long-term medical conditions. The nurses are, they say, leading the way for recruitment and engagement.
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Electronic Trial Master Files
Master the Art
According to Badr Fathi and Jens-Olaf Vanggaard at HighPoint Solutions, compliance should not be the main goal of the business when utilising eTMFs but rather the natural result of sustainable operational improvements.
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Clinical Trial Labelling
A Surprise Package
PRISYM ID’s Mark Cusworth believes that a possible reason for low patient retention is the labelling of drugs. Often overlooked, problems associated with language and the sheer volume of information that must be included need to be addressed to improve subject attrition.
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Regional Focus: Africa
Up and Coming
Despite the current challenges surrounding clinical trials in the region, Saravanan Thangaraj at Frost & Sullivan investigates why Sub-Saharan Africa could become an attractive study location as a result of continued regulatory and infrastructural advances.
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RBM Adoption
Survey Time
In a bid to improve quality and efficiency, change management practice is coming to the fore. Nicole Stansbury at PPD explores the implementation of risk-based monitoring and how surveys among clinical staff are aiding in driving this approach forward.
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Supply Chain Operations
Risky Move
The majority of pharma businesses rely on ICH guidelines to help mitigate risk in their supply chains. However, Mark Sawicki at Cryoport explains why this method needs to be re-evaluated in the wake of the shift from small molecule products to biologics and regenerative therapies.
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Adaptive Trial Design
Out of Control
In light of recent epidemics, Sujay Jadhav at goBalto proposes a method to bypass the often lengthy clinical trial process. Innovative study designs are needed to ensure that vaccines are approved as soon as possible in times of emergency.
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Patient Centricity
Focal Point
With ‘patient centricity’ being the current buzz term of the pharma industry, Bruno Gagnon and Nick Payton of Comprehend outline the advantages of this approach and illustrate how treating patients as consumers, rather than subjects, may be the answer that the sector has been looking for.
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Patient Recruitment
Human Touch
Clinical staff can aid and influence patient enrolment targets in studies, according to Stewart Rosen and Nicola J Smith of QuintilesIMS. They examine the role of clinical trial educators and how it is set to evolve in the future.
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Q&A: Global Compliance
Up in the Clouds
ICT talks to Michaeline Daboul from MMIS about current challenges faced by life sciences companies to comply with ever-evolving regulations, and how SaaS solution MediSpend® could help alleviate this burden.
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News and Press Releases |
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E Ink and Faubel Unveil the Med Label to Revolutionize the Clinical Trial Supply Chain
E Ink® Holdings, "E Ink" (8069.TW), the leading innovator of electronic
ink technology and Faubel & Co. Nachf. GmbH, a proven supplier to
the pharmaceutical and chemical industry, announced the availability of
the Faubel-Med® Label, a smart label for investigational medicinal
products. The Med Label features E Ink’s low-voltage film technology,
bringing display modules and new system designs to pharmaceutical
packaging.
More info >> |
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White Papers |
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Conveying Medical Guidance in Clinical Trials – A Survey
Europital Medical Consultancy
With the incremental demand for proactive safety surveillance throughout the conduct of clinical trials, the role of Medical Management is at the fore in ensuring the safety and wellbeing of the participants. The complex responsibilities of a Medical Monitor (MM) starts from the design and development phase, through to study close out. Understanding the principle behind the protocol and the prospective medical solution the study would deliver forms the bloodline for the MM role. Often, the MM is the face of contact for both the site personnel and the study team members with regard to medical, safety and scientific issues within the project.
When it comes to medical guidance, the communication channel used to deliver solutions contributes to a large extent in effectively managing decisive situations. Our previous study on acquiring medical guidance from an operations team perspective revealed that e-mails were the most used communication method (see the article, 'Talking Points', in ICT November 2014). In our efforts to further strengthen the mode of medical guidance delivery, we designed a survey to study the existing trend and constraints in this communication chain management, as outlined here.
More info >> |
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Industry Events |
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4th Annual Formulation & Drug Delivery Congress
8-9 May 2018, London, UK
Oxford Global are proud to present our hugely
popular 4th Annual Formulation & Drug
Delivery Congress, 8th – 9th May 2018, London, UK.Over 300 delegates representing global pharmaceutical
organisations, leading biotech companies and internationally renowned academic
institutions will gather for over 40 presentations and case studies focused on
the key issues in large molecule and small molecule drug formulation and drug
delivery.
More info >> |
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