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PUBLICATIONS

International Clinical Trials

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.

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.

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.

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.

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.

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.

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.

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.

Spotlight

The Difference a Step Makes

Signant Health explains the value of a purpose-built supply chain management solution.

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.

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.

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.

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.

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.

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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News and Press Releases

Merck Introduces Parteck® COAT Excipient, a Fast-Dissolving Material for Immediate Release Coating

• Designed to simplify the formulation and coating process for tablets • Optimized particle size leads to fast dissolving and increases coating process efficiency Merck has launched its Parteck® COAT excipient, a new functional material designed for immediate release film coating applications. Parteck® COAT is a particle engineered polyvinyl alcohol (PVA) with a unique particle structure that enables rapid dissolution even at low temperatures leading to an increased process efficiency.
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White Papers

Characterisation of Biopharmaceutical Proteins

Reading Scientific Services Ltd (RSSL)

Over the next five years it is anticipated that there is going to be an explosion in the numbers of biosimilar products coming to market as patents expire. Consequently, in line with regulatory guidance, there will be a commensurate need to provide full characterisation of such biopharmaceuticals. The purpose of this article is to describe the array of the more common techniques used in biopharmaceutical characterisation (typically of protein or polypeptide). For full characterisation of a protein, the proteinï¿½s primary, secondary and tertiary structure as well as its physiochemical properties should be assessed.
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Industry Events

Evolution Summit

20-22 July 2020, The Ritz Carlton, Fort Lauderdale, FL

The 22nd Evolution Summit is the premium forum bringing leading drug development executives and solution providers together. As an invitation-only event, taking place behind closed doors, the Summit offers an intimate environment for a focused discussion of key new drivers shaping drug development.
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