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 Contact Us

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.

Published quarterly in
February, May,
August, and November

News and Press Releases

Peli BioThermal showcase CoolPall™ Flex and industry leading solutions at Temperature Control and Logistics Conference

Peli BioThermal, the global name in temperature-controlled packaging, is exhibiting its industry leading shipper systems, including its innovative CoolPall™ Flex, at the 19th Annual Cool Chain Temperature Control and Logistics conference.
More info >>

All releases >>

White Papers

By Your Side for a Healthier World

West Pharmaceutical Services, Inc.

Every day, injectable drugs are administered to improve the lives of millions of patients around the world. And every day, West is working by your side to design and manufacture drug packaging and delivery systems that will bring our customers’ drugs from concept to the patient more efficiently, reliably and safely. West understands our customers’ challenges and helps with solutions every step of the way, with cutting-edge production technologies, an unmatched expertise in global regulatory compliance, and an ever-growing knowledge base of pharmaceutical drug product testing, development, packaging and delivery. Whether focused on one piece of the process or an end-to-end solution, West is by your side for a healthier world.
More info >>

All white papers >>

Industry Events

Clinical Operations in Oncology Trials West Coast

17-18 November 2020, Hilton San Francisco Airport Bayfront

Clinical Operations in Oncology Trials West Coast will be returning this April for another 2 day event full of thought-provoking presentations, discussions and roundtables. This years' conference highlights include the high-level, interactive immuno-oncology discussion panel where specialists from Shasta Bio Ventures, Abbvie and BeiGene shared their top tips on how to run successful and impactful immuno-oncology studies.
More info >>

All events >>