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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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BioIVT to Focus on the Application of In Vitro Hepatocyte Models in Toxicology Research at the North American ISSX Meeting
BioIVT, a leading
provider of research models and services for drug development, today announced
that it will be participating in several sessions at the 22nd North
American International Society for the Study of Xenobiotics (ISSX) Meeting.
This conference will be held from July 15-19 at the Palais des congrès de
Montréal in Montréal, Canada.
More info >> |
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White Papers |
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Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery
Presspart Manufacturing Ltd
Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
More info >> |
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Industry Events |
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SCOPE Europe: Summit for Clinical Ops Executives
16-17 October 2018, Barcelona, Spain
Building on the
success of its long-running US-based counterpart, Summit for Clinical Trials
Operations Executives Europe (SCOPE Europe) is a two-day event serving clin ops
execs, functional heads, category managers and those responsible for the
planning and management of clinical trials in Europe and the Rest of the World.
More info >> |
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