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| home > ict > Summer 2018 |
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 PUBLICATIONS |
International Clinical Trials |
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Regulatory Guidance on Outsourcing
Organising Outsourcing
Martin Robinson at IAOCR delves into the world of outsourcing as a part of clinical trials and provides a detailed account of how to receive advice and guidance through regulatory bodies.
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Dealing with Data Protection
Protecting Privacy
ICT spoke to Dr Andrew Rut at MyMeds&Me to discuss the all-important topic of patient data safety during clinical trials and the ways in which this sensitive issue should be approached.
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Q&A: Clinical Trial Transparency
Patient Privacy
ICT spoke to Thomas Wicks and Francine Lane at TrialScope about noncompliance, the risks and penalties it can lead to, and how to avoid running afoul of regulators.
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Improving the Clinical Trial Continuum
Perfecting Practices
Investments in new technologies to increase performances, gain greater quality, and encourage optimisation across trials are some of the most pressing topics for companies. Craig Morgan at goBalto provides an insight.
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Event Preview
Let’s Get Clinical
Get a taste of what to expect in this event preview if visiting Partnerships in Clinical Trials Europe this November, including one-to-one meetings, digital partnering, and networking with industry leaders from around the globe.
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Using Gamification and Behavioural Economics in Surveys
Gaining from Gamification
Creating a questionnaire for clinical trials can be fraught with difficulties, particularly when attempting to extract as much data as possible from respondents. Dr Keith Meadows at Health Outcome Solutions provides a clearer answer.
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Translation and Comprehension of Disease Activity
PRO Translation
Language barriers and translation issues when using patient-recorded outcomes over a multinational patient group are an essential consideration. The team at RWS Life Sciences tell us more.
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Site Engagement Technology
Appreciated and Informed
Using different scenarios to promote the use of site engagement technology, Dani Darasz and Lesley Freese at DrugDev comment on how clean trial data and protocol adherence can be greatly improved.
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Q&A: Partnerships in Clinical Trials Europe
Clinical Connections
With the upcoming Partnerships in Clinical Trials Europe event in November quickly approaching, ICT spoke to Louisa Maitland about what visitors can expect from the main streams.
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Robust Insurance Policies
Navigating Global Complexities
Kathryn Moon at Gallagher sheds some light on key insurance considerations, as deciding on a specific insurance policy can be one of the great difficulties a company faces when conducting clinical trials.
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Clinical Trials Liability Insurance
A Safety Net
Designed to excel if issues arise during any clinical trial, insurance is an essential and continuously evolving entity. Hanna Beaumont at La Playa explains some of the associated complexities in the industry.
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Current Trends in Outsourcing
Outsourcing Evolution
Outsourcing has been ongoing in the pharmaceutical industry for many years, but, as the methods develop, which is the right approach? Colin Stanley at ICON Functional Services explains.
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Functional Outsourcing Versus Full-Service Partnerships
Strategic Selection
Jeff Mayhew and Elizabeth Koury at LabConnect describe the top factors that companies should examine when selecting a strategic partner for assistance in clinical trials.
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End Point
Restricting Remedies
ICT’s Editor Dr Graham Hughes surveys the differing regulations regarding cannabis between the US and UK.
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News and Press Releases |
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Catalent Invests $175 Million to Expand Manufacturing Capabilities and Capacity at Winchester, Kentucky
SOMERSET, N.J. – May 19, 2022 — Catalent, the global leader in
enabling biopharma, cell, gene and consumer health partners to optimize
development, launch, and supply of better patient treatments across
multiple modalities, today announced that it has commenced a $175
million project to expand its flagship U.S. manufacturing facility for
large scale oral dose forms in Winchester, Kentucky. Two new buildings,
expected to be completed by January 2024, will add 107,000 square feet
to the site’s manufacturing footprint.
More info >> |
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White Papers |
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Characterisation of Biopharmaceutical Proteins
Reading Scientific Services Ltd (RSSL)
Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. Consequently, in line with regulatory guidance, there will be a commensurate need to provide full characterisation of such biopharmaceuticals. The purpose of this article is to describe the array of the more common techniques used in biopharmaceutical characterisation (typically of protein or polypeptide). For full characterisation of a protein, the protein�s primary, secondary and tertiary structure as well as its physiochemical properties should be assessed.
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