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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 Appoints Two New additions to its Commercial Packaging Sales Team


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White Papers

Modifying MDI Canister Surfaces to Improve Drug Stability & Drug Delivery

Presspart Manufacturing Ltd

Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack hazardous and environmentally-damaging effects. However, an HFA's active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels. Over the past few years, a number of surface coatings have been developed that can be applied to MDI canisters and valve components, to protect the contents from deposition and degradation. More recently, plasma processes have been developed to modify and improve the surface energy performance of a MDI canister. This approach has a number of advantages to alternative coatings but requires careful optimisation to ensure the highest quality finish and MDI performance. Richard Turner, Business Development Director, Presspart Manufacturing Ltd, explains.
More info >>

Industry Events

ASPIRE: International EDGE Conference

28 February - 1 March 2018, The Vox Conference Centre, Birmingham

The ASPIRE international conference is taking place on the 28th February and 1st March 2018 at the Vox Conference Centre in Birmingham. The conference brings together members of the research community including research professionals from the NHS, Clinical Trial Networks and international organisations. The ASPIRE conference will allow delegates to share knowledge and best practise with the focus on enhancing the efficiency and productivity of clinical research across the UK and beyond.
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