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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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Lynparza recommended for approval in EU by CHMP for BRCA-mutated metastatic pancreatic cancer
AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck
& Co., Inc. inside the US and Canada) today announced that Lynparza (olaparib) has been recommended for marketing authorisation in the
European Union (EU) for the 1st-line maintenance treatment of patients
with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer.
The
Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) based its positive opinion on results from the
Phase III POLO trial, which were published in The New England Journal of Medicine.
More info >> |
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White Papers |
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Device Develop for Combo Products
Phillips-Medisize
Combination products are defined as therapeutics combining two or more products (drug/device, biologics/device, biologics/drugs or drug/device/biologics), regulated and sold as a single unit. As these pharmaceutical and biological therapies and treatments have evolved, so has the need to develop appropriate delivery mechanisms for these applications. When developing a combination product, there are many things that need to be considered – the critical relationships between device development and the pharmaceutical or biologic, early establishment of regulatory and clinical strategies, understanding ‘user’ needs, determining product requirements, as well as, device manufacturing variation.
More info >> |
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Industry Events |
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Formulation and Drug Delivery Series UK
8-9 July 2020, Oxford Global
This event brings together leading formulation, drug delivery and biologics manufacturing experts from around the world across two days. The panel of prominent industry leaders and world-leading scientists will share the latest case studies, innovative developments for novel therapeutic products and strategies for drug development.
More info >> |
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