Samedan Ltd Pharmaceutical Publishers

Advanced search

Publications

European Pharmaceutical
Contractor

European Biopharmaceutical
Review

International Clinical Trials

Pharmaceutical Manufacturing
and Packing Sourcer

Innovations in Pharmaceutical
Technology

Subscribe Online

Conferences

White Papers

Samedan app

Pharmaceutical Directory

Industry Events Calendar

News and Press Releases

Employment Opportunities

Advertising with us

Air Transport Publications

home > ict > Winter 2012

PUBLICATIONS

International Clinical Trials

Winter 2012

Text

PDF

Regulatory & Business Practice

Companion Diagnostics

Biomarker Momentum

Berwyn Clarke of Lab21 Limited highlights the resurgence in the use of biomarkers in the clinical development process, and considers the implications of new technology and recent EU and US development guidelines.

Clinical Trial Outsourcing

Pharma-CRO Partnerships

Relationship Advice

Consultant John Faulkes considers the best course of action to ensure the sponsor-CRO relationship is successful, and suggests that building trust and regular communication when partnership-building is essential.

eCLINICAL

Drug Identication Links

Connecting Up

The ClinicalTrials.gov database has sought to increase the transparency of trial and drug data. Christopher Southan of ChrisDS Consulting and Hilary Stephenson of Sigma Consulting Solutions Limited suggest ways in which the resource can be improved.

Software-as-a-Service

Trial Management from the Cloud

Jan Nielsen at BSI Business Systems Integration AG surveys opinion on cloud-based CTMS systems, and highlights the factors pharma companies must take into account when adopting this software.

Developing Countries: Translation and EDC

Communication Crossroads

A number of challenges have prevented adoption of EDC in emerging countries but, as Karen I Politis Virk at Language Connections explains, progress is being made as a result of technological advances and translation guidelines.

MEDICAL IMAGING AND QT STUDIES

Cancer Drug Trials

Preclinical Targets

Bioluminescent imaging can aid preclinical efficacy assessments by providing patient relevant models. Rajendra Kumari at PRECOS discusses the role this imaging platform will play in cancer drug development.

Trial Management & Outsourcing

Budget Setting

Mature Approach

As the bid process for CROs becomes more competitive, John Bennett at JABPharma Ltd and Fiona Racher of Risk Decisions Limited recommend the adoption of a risk management strategy that allows sponsors to provide an accurate and reliable proposal.

Regional trials

Regulatory Compliance: Developing Countries

Principled Progress

Conducting clinical trials in developing countries offers a number of practical and economic advantages. However, as Aarti Pandey and Swaminath Ganesh at Wipro Technologies discuss, ethical considerations must not be forgotten.

Supply Chain & Manufacturing

R&D Outlook

Pressure on the Pipeline

Mark Egerton of Quotient Clinical suggests an innovative change to the supply chain process that will help the industry overcome the economic pressures that R&D is currently facing.

Recessionary Environment

Site Management

Survival of the Brightest

The effects of the economic recession are being felt in both Big Pharma and small biotech companies. Alan Wade at CPS Research highlights the benefits of increased efficiency and diversification.

Risk-Based Monitoring

Time for Change

Jules T Mitchel and Judith M Schloss Markowitz at Target Health Inc. consider the advantages of risk-based monitoring and direct data entry.

Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

News and Press Releases

When space is tight

Existing packaging lines can be retrofitted for serialization tasks, achieving a maximum of space savings and process reliability: if required, the system comes with an integrated checkweigher and tamper-evident labeler.
More info >>

All releases >>

White Papers

Future-proofing serialization solutions: the importance of strong level 3 capabilities

Adents

The complexities surrounding product serialization for pharmaceutical and medical device companies are immense. While current serialization requirements are limited to marking the unit of sale with a unique data carrier, by 2023 the process will require a product to be traceable through the entirety of its journey - from the individual package through the carton/pallet to its final point of distribution. In the United States, the Healthcare Distribution Management Association (HDMA) is suggesting that pharmaceutical companies begin to support this level of serialization, called aggregation, now. Around the world – in Europe and Asia in particular – disparate track and trace practices are incrementally moving toward a global standard that will, undoubtedly, be more stringent than today’s differing benchmarks. How can companies manage this transformation with the greatest degree of success while also minimizing business disruption? The key to creating an optimal implementation strategy is to select a serialization solution that has strong capabilities at all levels of technology. It’s also important to choose a solution that enables multi-phase implementation
More info >>

All white papers >>

Industry Events

SMI Immuno-Oncology Conference

25-27 September 2018, Copthorne Tara Hotel, London, UK

Immuno-Oncology is a fast-paced field with massive potential to deliver successful and durable cancer therapies, and SMi's Immuno-Oncology Conference will focus on a few key areas of the field with a representation of the whole industry under each area. These areas will be drawn together to look towards the future of Immuno-oncology and how the field can progress.
More info >>

All events >>