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International Clinical Trials

ict
Summer 2019

   
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End Point
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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Features
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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Regulatory Affairs
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
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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Regional Focus: South East Asia
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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Clinical Trials and Social Media
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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FSP Versus Full Service
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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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

AirBridgeCargo expands its passive pharma solutions in partnership with SkyCell as it achieves the two-fold volume increase

AirBridgeCargo expands its passive pharma solutions in partnership with SkyCell as it achieves the two-fold volume increase AirBridgeCargo Airlines (ABC), one of the leaders in transportation of pharmaceutical products by air, and Zurich-based cold-chain ULD manufacturer SkyCell have sealed their partnership for the lease of all types of SkyCell containers to meet the demand for evolving volumes of passive pharmaceutical shipments, which reached around 3,500 tonnes for 1Q 2019 YOY and demonstrated a two-fold increase.
More info >>

White Papers

Finding the Right End-to-End Safety Solution for Your Needs

Bioclinica

With upcoming changes, including the implementation of the International Conference on Harmonisation (ICH) E2B(R3) Electronic Transmission of Individual Case Safety Report and Identification of Medicinal Products (IDMP) standards, the current state of safety reporting can be confusing. Your existing safety system may not be flexible enough to accommodate these changing regulations, which are still moving targets regarding the details needed for a comprehensive solution with the right level of processes, company-to-company integrations and finalized regional rules.
More info >>

Industry Events

SAPHEX 2019

23-24 October 2019, GALLAGHER CONVENTION CENTRE, 10 RICHARDS DRIVE, HALFWAY HOUSE, MIDRAND, 1685, SOUTH AFRICA

SAPHEX 2019 will be held on the 23rd-24th October at the Gallagher Convention Centre, Johannesburg, South Africa.
More info >>

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