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| home > ict > Summer 2019 |
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 PUBLICATIONS |
International Clinical Trials |
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End Point
Then and Now
ICT’s Editor, Dr Graham Hughes, looks back to 1959 and examines the differences in the pharmaceutical industry between then and now, as well as how much further we have to go.
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Patient Centricity in the Product Lifecycle
The Patient Journey
For Susan Najjar at Sciformix, a Covance company, it is essential to
develop business strategies that are centred on the patient to allow
them a greater control over their own treatment.
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Q&A: Selecting Your CRO
Finding the Right Fit
There are many factors to consider when choosing your CRO, and Catherine Konidas at Altasciences speaks with ICT to help guide you through this critical process.
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Spotlight
Moving in a New Direction
Clinical Trials Europe will be taking place in Barcelona, Spain, and Louisa Maitland at KNect365 speaks with ICT about the changes to the scope of the conference, with a new and broader focus.
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Enrolment Planning Technology
Plan, Track, and Refine
Enrolment planning technology will help optimise strategies and meet milestones, maintaining the long-term health of your clinical trials, argues Mark Springer at IQVIA Technologies.
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Q&A: Remote Data Collection
Therapeutic Oncology and the Road Ahead
The world is changing, as are the means of capturing and compiling outcomes data. Dr Tim Williams at My Clinical Outcomes answers questions from ICT about the current and future trends in therapeutic oncology.
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Improving the Chances of FDA Approval
Expert Tips for a Successful Application
Dr Harneet Arora at Kolabtree provides guidance in the nervewracking process of submitting a drug for FDA review, from organising your paperwork to a better presentation of evidence.
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Cell Therapy Starting Materials
The Landscape of Clinical Approval
HemaCare's Dominic Clarke and Brad N Taylor expand on the FDA and EMA's attempts to accelerate cell therapy drug approvals under the new Regenerative Medicine Advanced Therapy designation.
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Clinical Trial Application Processes
Outsourcing Trial Applications
Paul Carrodus at TMC Pharma Services explains why regulatory guidance and legislation can have significant implications when outsourcing applications to EU competent authorities.
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Pharmacovigilance Outsourcing
The Long and Short of CRO Selection
PharSafer’s Graeme Ladds assesses the responsibilities of sponsors and licence holders for pharmacovigilance outsourcing, and how knowledge, geography, and scope are all important factors in the decision process.
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Pharmacovigilance and GDPR
Post-Marketing Pharmacovigilance
From European legislation to GDPR compliance, Emma Boulton and Dora Amene at PIPA analyse the importance of data protection in pharmacovigilance systems.
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Clinical Trials in Asia Pacific
The Pacific Century
With an expanding economic and regulatory landscape, the clinical trials industry in the Asia Pacific is booming. CIDP Singapore’s Bandana Seesurn explores the reasons behind this growth.
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Healthcare and Social Media
Transforming Clinical Trials
CREATION’s Jamie Doggett describes how the increasing use of social media and online platforms by healthcare professionals can ensure improved access and aid in clinical trial recruitment.
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Social Media in Clinical Research
Patient Recruitment in the Digital Age
Social media has opened up a world of possibilities for patient recruitment in clinical trials, explain Miaesha Campbell and Amanda Siegert at Medpace.
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The Benefits of a Functional Service Provider
The Service Model Dichotomy
Quanticate’s Daniel Chapple highlights the differences between full-service models and functional service provision to help trial sponsors find the optimal solution for supporting clinical development.
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Sustainable Service Provision
Choosing a Winning Model
From uncapped time and materials to fixed fee approaches, Jo Marshall at CROS NT outlines the four basic service models and how best to achieve ‘sustained quality’.
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News and Press Releases |
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Sphere Fluidics expands into additional facility at Granta Park in Cambridge, UK
New offices at leading science
hub support the Company’s rapid growth following recent investment
New facility is in addition to
headquarters at Babraham Research Campus, Cambridgeshire, UK and offices
in Monmouth Junction, New Jersey, USA
More info >> |
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White Papers |
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Backward Thinking
Development of a generic equivalent to a current marketed pressurized metered dose inhaler (pMDI) product brings immense challenges. Thorough analysis is critical to gain a comprehensive understanding of the physical attributes and pharmaceutical performance of the reference marketed product. Many factors need to be assessed, understood and combined in order to successfully develop a generic pMDI which will meet the regulatory and quality requirements as an equivalent product in the anticipated target market.
More info >> |
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Industry Events |
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SCOPE Europe – Summit for Clinical Ops Executives Europe
17-18 September 2019, Barcelona, Spain
Building on the success of its long-running US-based counterpart, Summit for Clinical
Trials Operations Executives Europe (SCOPE Europe) is a two-day event serving clinical
innovation leaders, clin ops execs, functional heads, category managers, and those
responsible for the planning and management of clinical trials in Europe and the Rest of
the World. The event will feature opening and closing plenary keynote sessions, five
conference tracks, interactive breakout discussion groups, and networking.
It is an opportunity for leaders from large, mid-sized, and small pharma, specialty
pharma, biotech, vendor companies, and academic research centers to come together to
share best practices and discuss the new era of analytics-driven and patient-centric
trials.
More info >> |
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