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International Clinical Trials

ict
Winter 2017

   
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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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Regulatory & Business Practice
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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Clinical Trial Management
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 Supply & Packaging
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 trials
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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Ethics & Risk Management
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 & Manufacturing
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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Trial Design
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 Recruitment and Retention
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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Interview
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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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

News and Press Releases

ERT’s eCOA Environment Accelerates Research Without Technology Getting in the Way


More info >>

White Papers

Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services

DrugDev

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
More info >>

Industry Events

SMi_Paediatric Clinical Trials

20-21 March 2017, Copthorne Tara Hotel, London, UK

SMi is proud to present the return of their 11th annual Paediatric Clinical Trials Conference, 20th – 21st March 2016, London.   Strengthening strategies in paediatric investigation plans remains paramount and with the EMA 10 year review of paediatric regulation a call has been made for greater guidance with the goal of increasing the number of safe paediatric therapeutics on the market.  
More info >>

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