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International Clinical Trials

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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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Published quarterly in
February, May,
August, and November

News and Press Releases

PCI Pharma Services Announces Further Expansion in San Diego to Maintain Industry-Leading Quality, Service and Flexibility

Philadelphia, PA – June 4, 2019 PCI Pharma Services (PCI), a leading biopharmaceutical outsourcing services provider, has announced the growth of its West Coast Clinical operations with expansion into its third facility in San Diego.
More info >>

White Papers

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 >>

Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

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