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International Clinical Trials

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Autumn 2012

   
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REGULATORY
Pharmacovigilance

Safety Signals

Peter B Bottini at Norwich Clinical Services delves into the world of pharmacovigilance and argues that it is crucial for responsible organisations to actively engage in the process in order to reduce safety issues.
 
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Clinical Trial Management
Mega-Trials

Big Shot

Mega-trials require specialised knowledge in terms of regulatory compliance. Hans-Peter Guler and Kelly Henkel at INC Research outline what this knowledge entails and how best to adhere to the rules, as well as successfully manage the economic pitfalls of a trial.
 
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Cross-Border Clinical Trials

Border Control

John Blakeley at Greenphire explores how the new European Commission proposals strive to make Europe a more appealing region in which to carry out clinical trials, and considers why there is a general feeling that the pharmaceutical industry should aim to cut trial administration costs.
 
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Multi-Site Trials

The Clinical Trial Landscape

Automated and scalable solutions for the management of concomitant medication in global clinical trials would appear to be the next step for research. Mark Dale at MAC Clinical Research outlines the relevant advantages and challenges.
 
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CNS Disorders

Scene Change

Frederick T Lewis at PRA points to a range of solutions that may help to alleviate the array of potential challenges facing global clinical trials for Alzheimer’s disease and multiple sclerosis.
 
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eCLINICAL
eClinical Systems

The Road Ahead

In the age of digital data, it is necessary for eClinical systems to be malleable to the ever-changing range of electronics. Bill Cooney at Medpoint outlines the criteria that he believes it will be necessary to adhere to.
 
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MARKETPLACE
Strategic Partnerships

Hidden Gems

Partnerships between CROs and service providers have long been a hot topic in the pharma world; however, Stephen Plotkin at MDSL International believes that smaller companies in particular can reap the benefits from these tactical unions.
 
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Regional trials
Poland: Regulatory Compliance

Different Country, Different Rules?

As central and eastern Europe grows in popularity as a region for conducting clinical trials, CROs are turning to Poland on a more regular basis. Bozena Ciosek and Marta Godamska-Gołab at Wierzbowski Eversheds explain how changes in EU regulations could affect this trend.
 
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Ukraine: Regulatory Compliance

Cracking Kiev

With the emergence of Ukraine in the clinical trials sector, Oksana Maksimova and Tetyana Demidenko at CTL outline how the legal landscape of the country is being transformed, and the economic boost that this will facilitate for the region.
 
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eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
Electronic Medical Records

Big Data, Big Results

Simon Beaulah,Robin Munro and Paul Denny-Gouldson at IDBS argue that big data could hold the key to improving patient outcomes, but explain that investment will be required in order to access the full benefit of this technology.
 
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data management & statistical analysis
Clinical Data Traceability

Store Cupboard

In clinical trials, it is essential that sponsors are able to accurately locate and retrieve all the data generated on a product. Michael Whitworth at Quanticate runs through some of the key challenges that are faced, and why it is important to overcome them.
 
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Adaptive Data

Quest for Quality

Lucia Simoni and Giovanni Fiori at MediData srl outline their ‘five Ws’ concept relating to observational research, and why they believe that these must be followed when conducting any observational study.
 
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Labs & Logistics
Sample Storage

Smart Biobanking

Biobanking is a concept that sparks controversy. Divyaa Ravishankar at Frost & Sullivan considers whether it could be a viable option in the long-term, and how researchers can ensure the integrity and usability of samples.
 
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Cancer Therapeutics
Biomarkers

Forward Planning

As predictive biomarkers take centre stage in cancer therapies, Jason Yang, Martine Poelman, Rachel Reams, Thomas Turi and Nasser Azli at Covance take a look at what has prompted this growing trend and whether or not it can assist drug evaluation and reduce late stage failures.
 
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Reviews
Book Review:

Playing the Field

Graham Hughes reviews Global Clinical Trials Playbook – Capacity and Capability Building, edited by Menghis Bairu and Richard Chin.
 
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Interview
PCT Interview

Tight Connections

Sarah Palit of Informa Life Sciences opens up to ICT about the upcoming Partnerships in Clinical Trials event in Hamburg later this month.
 
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Industry Interview:

Thinking Allowed

Elena Logan of PPD talks to ICT about her predictions for 2013 and the significance of relationships in the new contract research landscape.
 
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Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August, and November

News and Press Releases

PCI and CSP Technologies, Inc. Announce Strategic Collaboration for Breakthrough Activ-BlisterTM Solutions

Philadelphia, PA & Auburn, AL – September 17, 2018 PCI Pharma Services (PCI), a full-service provider of specialist outsourced drug manufacturing, clinical trial services, and commercial packaging to the global healthcare industry, is pleased to announce its exclusive collaboration agreement with CSP Technologies, Inc. for U.S. clinical trials and stability testing utilizing Activ-BlisterTM packaging solutions, which help protect and promote speed-to-market for pharmaceutical and medical device products with heightened susceptibility to moisture and gases, especially oxygen.
More info >>

White Papers

Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials

Perceptive Informatics

Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
More info >>

Industry Events

CPhI & P-MEC India 2018

12-14 December 2018, India Expo Mart, New Delhi, India

CPhI & P-MEC India (December 12-14, 2018) – organised by UBM (part of Informa PLC) – announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi. The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.
More info >>

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