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

3P Biopharmaceuticals and Nordic Nanovector have extended partnership for Betalutin® late stage manufacturing for B-cell non-Hodgkin lymphoma (NHL) treatment

The non-Hodgkin lymphoma (NHL) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system
More info >>

All releases >>

White Papers

e-tools enhance clinical trial performance

e-novex

In today’s ever-evolving medical business, technological changes require innovation to meet growing market demands and to bring about advances in the industry. One such development currently taking place in the field of clinical research is how e-tools are initiating a boost in the productivity of clinical trials.
More info >>

All white papers >>

Industry Events

Clinical Trial Supply Europe

11-12 March 2020, Madrid, Spain

The 21st annual edition promises to grow on the success of 2019’s excellent conference which saw delegates from Europe’s largest pharmaceutical companies and biotech innovators come together to discuss, debate and unpack the latest trends in clinical supply chain innovation. 2020 will offer delegates the opportunity to address the growing need for agility within the supply chain in response to increasingly complex trial demands. With a stream dedicated to supply operations and another to innovative uses of technology in the supply chain, delegates will get the chance to gain practical take-aways that they can apply to their own studies.
More info >>

All events >>