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International Clinical Trials

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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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Published quarterly in
February, May,
August, and November

News and Press Releases

Cognizant Shared Investigator Platform for Life Sciences Reaches Major Milestone in Accelerating Drug Discovery

Cognizant (Nasdaq: CTSH) announced that its Shared Investigator Platform (SIP), a life sciences Software as a Service (SaaS) solution, has reached a new milestone of over 100,000 users in 84 countries. The platform has become increasingly critical to progressing clinical trials as prevailing social distancing norms have significantly curtailed in-person collaboration.
More info >>

White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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Industry Events

World Vaccine Congress Washington

27-29 September 2020, Walter E Washington Convention Center, Washington, US

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

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