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International Clinical Trials

ict
Winter 2018

   
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REGULATORY
The Great Data Protection Regulation

Protected and Prepared


To protect personal data, the industry must adapt to a new set of practices implemented by the Great Protection Regulation, as explained Mike Novotny and Nick O’Brien at Medrio.
 
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Risk Management Methods

Preventable Problems

Sudeep Pattnaik at ThoughtSphere examines risk-based monitoring methods, suggesting that they are becoming the newly recognised industry standard.
 
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Clinical Trial Management
Central Nervous System Trials

Clinical Complexities

Clinical trials for the central nervous system are becoming more intricate and expensive. Tom Zoda at Syneos Health discusses the challenges that must be overcome in this sector.
 
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Patient Engagement and Compliance

Perfect Platform


Following the guidelines set out by the Washington University DIAN-TU platform, Graham Wylie at MRN states that these standards are good for current practices, noting the ways it affects Alzheimer’s research.
 
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CNS Drug Development

Clinical Acceleration

Dr Kemi Olugemo
at PAREXEL highlights how the need for an increase in clinical trials is vital as diseases caused by the central nervous system accelerate.

 
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Clinical Reference Models
Bridging the Divide

Using electronic document management and trial master file reference models can offer assistance when managing the growing amount of regulatory
submissions, explains Patricia Santos-Serrao at MasterControl.
 
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eCLINICAL
Digitising Patient-Reported Outcomes

PROMs in Practise


By using digital patient-reported outcome measures, healthcare organisations are now able to measure patient outcomes with greater accuracy. Dr Tim Williams at My Clinical Outcomes details the ways this helps care and practices.

 
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PREVIEW
Uniting professionals across life sciences, DIA Europe 2018 will be held this year in Basel, Switzerland, on 17-19 April.
 
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data management & statistical analysis
Mitigating Data Risks
 
Promoting Patterns
 
Poor data management is negatively affecting adverse event and endpoint adjudication in clinical trials. Abraham Gutman at AG Mednet believes developing and validating control and event patterns may be the solution.

 
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Patient Recruitment and Retention
Patient Retention
 
Dodging Delays
 
Martin Collyer
at Bioclinica talks about the new methods that must be taken to reduce patient-loss during the follow-up period.

 
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Behavioural Economics

Assessing Attitudes
 
Creating and maintaining patient engagement has been researched in numerous ways. One of those approaches is Behaviour Economics, which Keith Meadows at DHP Research & Consultancy explores.

 
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Patient Participation
 
Changing Ways
 
Kurt Mussina at Frenova Renal Research points out that recruitment rates can be improved through patient-centricity, thereby minimising administrative and practical difficulties.
 
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Patient Centricity

Promising Participation


Lea Studer at SCORR Marketing examines the role of patient centricity within trials, suggesting that the process could be improved by keeping patients informed, seeking their input, and analysing their desires
 
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Patient-Reported Outcomes

Collective Communication


The collection of patient-reported outcomes in clinical trials has become more commonplace; however, Dr Jenny Retzler at York Health Economics Consortium explores the problems that may be countered though early engagement.
 
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Digital Advances
mHealth Developments

A Valued Perspective

The acceleration of R&D is coming to fruition thanks to the implementation of mHealth technologies. David Blackman at PPD hopes it will improve practices and explore new markets.
 
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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

New to the PPMA Show 2018: Bright Ideas - Ambassador Programme

A new initiative for PPMA Show visitors this year is the Bright Ideas - Ambassador Programme - a free advice service for start-up ventures and entrepreneurs.
More info >>

White Papers

Igb Tamper Evident Folding Box

IGB

The easiest, safest and less expensive solution in compliance with what requires Dir. 62/2011/EU, FDA and TGA.
More info >>

Industry Events

SAPHEX 2018

1-2 November 2018, Gallagher Convention Centre, Midrand, South Africa

The SAPHEX exhibition and conference is now established as the “go-to” networking and business event for anyone working in the South African pharmaceutical manufacturing industry.
More info >>

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