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PUBLICATIONS

International Clinical Trials

Winter 2019

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Clinical Trial Supply & Packaging

Adaptive Trial Designs

Redefining the Gold Standard

Detailing the process of a trial is pivotal to its success, and developing an adaptive trial can improve the outcome. However, there can be complications to this method, as demonstrated by Dr Chitra Lele and Dr Ritu Budania at Sciformix.

Trial and No Error

The Evolution of Environmental Monitoring

Jukkapekka ‘JP’ Asikainen and Ossi Laakkonen at Sensire discuss the technicalities and subtleties of the technologies available to improve clinical trial supply and how best to select one.

Regional trials

Clinical Trials in Southeast Asia

Finding Future Markets

Namjoo Seo and Maree Ward at PRA Health Sciences examine Southeast Asia as a prime location for clinical trials while looking into the drawbacks of the region.

THERAPEUTICS

Addressing an Epidemic

Improving Outcomes in Diabetes Research

Capturing and examining data is one of the most effective ways to understand the true number of diabetes sufferers and the associated complexities of the disease. Katie Garner at CRF Bracket explains more.

Digital Advances

Developing Clinical Trial Designs with Artificial Intelligence

The Balanced Approach to Optimising Clinical Trial Design and Execution

Gen Li PhD, Paul Chew MD, and Jonathan Peachey at Phesi explore the different methods of artificial intelligence available to increase the chance of a successful trial, ultimately resulting in beneficial data.

Vaccine Trials

Q&A: Pathological Rat Race

Animal Models to Study Infectious Pathogens

Carmen Sweeney PhD at Charles River spoke to ICT to provide insight into the use of cotton rats in animal models and why they could be an essential asset in fighting a wide variety of human pathogens.

Features

CRA Recruitment

Specialist Shortage

Steve Lord at CK Clinical reviews future clinical research associates recruitment, how their roles are perceived in the industry, and how to encourage a career in clinical trials.

Risk-Based Monitoring

Strategic Success

There are several complexities when dealing with risk-based monitoring. Patrick Hughes at CluePoints spoke to ICT to provide guidance on risk-based monitoring and how the right technology can drive it further.

Automating Inventory Management in Healthcare

Automatic Improvements

Improving efficiency and accuracy is always a key target for healthcare facilities, and automation may provide the solutions for the industry. Jonathan Wilkins at EU Automation explores the available options.

Helping Hearts

Concentration-QT Modelling in Early Phase Clinical Studies

With the development of new medications comes the risk of unexpected side effects. Dr Andreas Lindauer at SGS Exprimo explains how strict drug development assessment can avoid this issue.

UK First-In-Human and Early Clinical Trials

Advancing Expansion

Dr Simon Hutchings at Simbec Research looks at the UK’s leading role in first-in-human clinical trials and how the experiences of each trial are enhancing the industry guidelines.

Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

Pharmapack success points to sizeable growth potential for global drug delivery and packaging in 2019

Paris, 19th March 2019: The drug delivery and healthcare packaging industry is set for significant growth in 2019 as Pharmapack Europe (#pharmapackeu) – a key bellwether of industry health – welcomed a record 410 exhibiting companies and nearly 5,500 attendees from 75 countries. Europe’s biggest pharmaceutical packaging and drug delivery event (Paris Expo, Porte de Versailles, France 6-7 February, 2019) saw a diversification of innovations and new drug delivery solutions, with ‘patient-centricity’ emerging as the central theme throughout this year’s edition.
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White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
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Industry Events

Highly Potent Active Pharmaceutical Ingredients (HPAPI)

13-14 May 2019, Copthorne Tara Hotel, London, UK

SMi is delighted to announce its 3rd Annual Highly Potent Active Pharmaceutical Ingredients conference coming to London on the 13th-14th May 2019. The HPAPI global market has developed rapidly in the past year and is continuing to expand into the future, with over a quarter of drugs in development worldwide being classified as highly potent. As a result, there is a growing demand for both pharmaceutical and contracted manufacturers to adapt to the evolving HPAPI landscape.
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