spacer
home > ict > Summer 2010
PUBLICATIONS

International Clinical Trials

ict
Summer 2010
   
Text
PDF
bullet
Regulatory & Business Practice
John Lewis of the Association of Clinical Research Organizations assesses recent findings demonstrating the effects of culturally specific regulations on patient participation, and the hidden burden facing physicians.  
view
download pdf
Past mistakes should be avoided through researching sources carefully and developing strong foundations for dialogue. Hugh Davies of the National Research Ethics Service presents an approach to utilise resources when reviewing the ‘facts’ more efficiently.

 

 
view
download pdf
Incorporating the planning of integrated summaries from the beginning of the process of a product’s approval can avoid a lack of clarity when making key decisions; Michael Whitworth from Quanticate investigates.  
view
download pdf
bullet
TRIAL MANAGEMENT
Pharma companies now spend up to 60 per cent of their R&D capital on clinical trials and make significant losses each day that there’s a setback. As patient participation is one of the principal factors that can lead to such delays, Benjamin Jackson of Quartesian recommends internet-based recruitment as a targeted way of finding willing patients.  
view
download pdf
Kim Boericke at i3 Research and Bill Gwinn at i3 Pharma Informatics discuss the importance of protocol design, country and site selection, investigators’ experience and patient recruitment before the start of any study to ensure a speedy conclusion.  
view
download pdf
James McRedmond of Java Clinical Research points out that the pharmacodynamic effects of a drug is what allows for better decision-making in the clinical development process, and draws attention to how one can improve the accuracy and quality of the data obtained.  
view
download pdf
Despite shrinking budgets the late phase research sector grew last year, seeing global outsourcing rise and post-market surveillance increase. David Selkirk of Omnicare Clinical Research asserts how late phase research can continue to provide benefits to the industry as a whole.
 
view
download pdf
bullet
Regional trials
As Latin America becomes an increasingly popular destination for clinical trials – with the number of studies conducted in the region expected to increase by an average of 20 per cent each year – Fernanda C Durán and Valeria Francesconi at PharmaNet Development Group consider the potential benefits and challenges for companies considering this move.  
view
download pdf
eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
As well as embracing and adapting to new technologies, pharma companies need to remember that no solution is effective in isolation. Jim DeSanti of PharmaVigilant explains how EDC and EMR systems can work together to achieve more efficient results.  
view
download pdf
How organised are you when it comes to creating internal documents with several inputs – who is doing what, when, and on which version of the file? Kris Sæther and Andreas Jordell at Xait suggest ways to ensure constructive collaboration.  
view
download pdf
Christina Hughes and Kimberly Foulds at United BioSource Corporation explore ways of reducing variability in clinical data due to subjective endpoints, focusing on video surveillance and how this method can actually improve the overall quality of data accrued.  
view
download pdf
bullet
DRUG DISCOVERY & DELIVERY
It is estimated that 70 per cent of new chemical entities entering drug development programmes are unable to undergo sufficient gastrointestinal absorption to ensure efficacy. John McDermott of Quotient Bioresearch believes that early screening of prototype formulations is beneficial to avoid delays to the process.  
view
download pdf
James Blakemore and Brennan Miles of Team Consulting Ltd discuss the importance of considering medical device function and design during the concept generation stage – pointing out that, in the end, the suitability of the overall product to the user is what will determine the level of the drug’s commercial success.  
view
download pdf
bullet
Labs & Logistics
With testing options changing constantly, and protocols becoming more complex, central labs have a pivotal role to play in the conduct of clinical trials. Elena Logan of ACM Global Central Lab considers how outsourcing will continue to affect lab testing.  
view
download pdf
Reflecting on the evolution of the central laboratory, Thomasz Anyszek of LabConnect Europe and Synevo Central Laboratory, and Eric Hayashi and Frank D Morrow of LabConnect, LLC discuss the ongoing advantages and disadvantages of local and central frameworks.  
view
download pdf
As the possibility of integrating emerging markets into clinical research supply chains increases, Alex Klim and Eddie Aston of DHL Supply Chain offer an insight into the potential obstacles that lie ahead.  
view
download pdf
   
spacer


Published quarterly in
February, May,
August, and November

News and Press Releases

Merck Introduces Parteck® COAT Excipient, a Fast-Dissolving Material for Immediate Release Coating

• Designed to simplify the formulation and coating process for tablets • Optimized particle size leads to fast dissolving and increases coating process efficiency Merck has launched its Parteck® COAT excipient, a new functional material designed for immediate release film coating applications. Parteck® COAT is a particle engineered polyvinyl alcohol (PVA) with a unique particle structure that enables rapid dissolution even at low temperatures leading to an increased process efficiency.
More info >>

White Papers

ConsulTech GmbH

ConsulTech GmbH

ConsulTech is a consulting company founded in 1992. Since then, we have been supporting biotech-nology, pharmaceutical and medical technology companies as well as research institutions with the entire process of setting-up and executing proposals for R&D projects. In projects funded by the European Commission, ConsulTech supports the coordinator by resuming administrative tasks allow-ing coordinators and partners to fully concentrate on the scientific and technical success of the pro-ject. We solve financial and administrative issues, organise meetings, take care of the timely delivery of milestones and reports and much more.
More info >>

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 >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement