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International Clinical Trials

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Winter 2020

   
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Features
Keeping Trials Connected

Stephen Byrne at KORE

Adopting a more connected clinical trial system can overcome the problems faced by constantly evolving technology and network sunsetting.
 
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Paediatric Trials
We Can Do Better: Key Considerations for Paediatric Trial Success

Mark Sorrentino at PRA Health Sciences

Enrolment and recruitment challenges in paediatric trials may be mitigated by aspects of trial design that are within our control.
 
 
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RACE for Children Act: Product Development Considerations

Lynne Georgopoulos at Synteract

August 2020 will bring new regulations on cancer drugs for paediatric patients, raising questions on the requirements of drug developers.
 
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Removing Barriers for Paediatric Patients in Clinical Trials

Evelyn Kamau at the MRN

The disparity in clinical trials conducted on adult patients vs children brings important discussions on quality-based care for paediatric patients.
 

 
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Spotlight

Think of the Children: Clinical Trial Considerations at Home

Illingworth Research Group presents how it tackles the challenges of paediatric patient retention and consent in clinical trials.
 

 
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Optimising Trial Design Across the Ages

Michael Oldham, MD, Michelle Petersen, Katharine Shore, and Christina Vonderhaar at Medpace

Regulatory interest in paediatric trials continues to mount, and careful planning across multiple functional areas in trial design is becoming even more vital.
 
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Clinical Trial Supply
IMP Integrity

Vincent Santa Maria and Tony Heeley at Parexel International

Robust planning and optimisation are essential to future-proof the supply chain for investigational medicinal products.

 
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The Drivers of Success in Ancillary Supply Chain Management

Dr Joanne Santomauro at Ancillare

While pharma companies increasingly focus on outsourcing efforts, effective ancillary supply chain management is often neglected.

 
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Spotlight

The Difference a Step Makes

Signant Health explains the value of a purpose-built supply chain management solution.
 
 
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Comparator Sourcing in Clinical Studies (Part One of Two)

Toby Watkins at CTSS

The first of this two-part article gives a broad overview of the challenges inherent in comparator sourcing, as well as key players in comparator supply.

 
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The Rise of Direct-to-Patient

Brian Swites at Clinigen Group

With a shift in focus in the healthcare industry towards patient centricity, a direct-to-patient supply chain continues to grow in popularity.

 
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Comparator Sourcing in China: Three Key Trends for a New Decade

Viktor Sandstedt at Inceptua

During the 2010s, there were many barriers to trial opportunities in China, but these challenges may be surpassable.

 
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Data Protection
Harmonising Requirements in the EU

Magdalena Lewandowska at DIA

There are important distinctions to make around the interplay of EU CTR and GDPR across the product lifecycle.

 
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Security, Compliance, and Control

Georgina Stockley at Boldon James

Five key steps can be identified to avoid accidental data loss or leakage, which is vital for maintaining effective data protection.
 

 
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The Impact of GDPR for Health Organisations

Luis Ángel del Valle at SealPath

The 2018 EU GDPR was the first major push by health organisations in a growing effort to protect previously susceptible patient data.
 

 
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February, May,
August, and November

News and Press Releases

AirBridgeCargo Airlines steps into COVID-19 vaccine transportation phase

AirBridgeCargo Airlines, part of Volga-Dnepr Group, has accomplished its first COVID-19 vaccine transportation from Beijing (China). The delivery of CanSino's Covid-19 vaccine has been orchestrated in partnership with UPS/Marken onboard one of the carrier’s Boeing 747 freighter.
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White Papers

Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services

DrugDev

With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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Industry Events

DIA Europe 2021

15-19 March 2021, VIRTUAL CONFERENCE

DIA Europe is the must-attend event for all life science professionals working in drug development, from discovery to marketed use. It encourages open collaboration by bringing together representatives from the entire spectrum of the life science landscape and facilitating crucial discussions across several topic tracks: Clinical Development, Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy, and many more.
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