spacer
home > ict > Spring 2013
PUBLICATIONS

International Clinical Trials

ict
Spring 2013

   
Text
PDF
bullet
Regulatory & Business Practice
Data Transparency

Going Public?

Should all clinical trial data be made publicly available, or would this be an alarmist move that could cause mistaken safety concerns? Rupert Gilbey from Samedan Ltd heard both sides of the argument at a recent industry debate.
 
view
download pdf
Innovation in R&D

Box Clever

The UK government’s new Patent Box preferential tax regime recognises the strategic and economic importance of the life sciences industry. Nick Beckett at CMS Cameron McKenna fills us in.
 
view
download pdf
bullet
Clinical Trial Management
Home Trial Services

Inside Story

A new and powerful tool for improving recruitment and retention, home trial support can speed up trials and reduce patient burden. Graham Wylie at Medical Research Network outlines the nuts and bolts of this service.
 
view
download pdf
Project Management

Leading Edge

Eric Morfin at Critical Skills Inc examines the importance of nurturing future project managers and leaders in clinical trials, outlining the appropriate behaviour-based skills and styles.
 
view
download pdf
Patient Engagement

Get Connected

Mobile and digital technology can be used to capture clinical outcomes at the point of experience, helping pharma companies to engage with patients globally, in any language at any time. Tim Davis at Exco InTouch explains.
 
view
download pdf
Professional Standards

Live and Learn

A lack of competency-based qualifications for clinical research points to the need for internationally recognised accreditation. Martin Robinson at the International Academy of Clinical Research proposes a new framework.
 
view
download pdf
Patient Adherence

Missing Link

The lack of patient adherence recorded in many clinical trials leads Dorothy Smith at Consumer Health Information to ask: how safe is the prescribed dose of some drugs on the market?
 
view
download pdf
Investigator Grants

Forward Thinking

Linda Drumright at IMS Health considers the tricky issue of estimating investigator grants, emphasising the value of using historical performance benchmarks to more accurately forecast the costs.
 
view
download pdf
Progression-Free Survival

Under Review

An independent review committee can add value to the use of progression-free survival endpoints in oncology trials. A potential new approach is explored by Kristin Borradaile, Kevin Duffy and J Michael O’Neal at BioClinica.
 
view
download pdf
Phase 1 and 2a Trials

Early Action

International perspectives on a host of hot topics were shared at the recent Phase 1 and 2a Clinical Trials Conference, attended by Graham Hughes.
 
view
download pdf
bullet
eCLINICAL
Electronic Patient Data

ePRO Update

Electronic platforms could give a new lease of life to patient-reported outcomes for clinical trial endpoints. J Jason Lundy at the Critical Path Institute looks at the adaptation of paper-based instruments and what the future might have in store.
 
view
download pdf
bullet
Regional trials
Infectious Diseases: China

Eastern Time

Its large pool of treatment-naïve patients makes China a potentially strong market for clinical studies, although protracted approval timelines, cultural barriers and competition for resources are among the challenges. Steven Lobel, Carol Olson and Beth Tulip at PPD report.
 
view
download pdf
Asian Markets

Culture Trip

Amid the advantages of the Asian region, trial sponsors should ensure that results are not compromised by linguistic, cultural and behavioural differences, says Gary Muddyman at Conversis.
 
view
download pdf
bullet
data management & statistical analysis
ECG Measurements

Use and Principles of Automated Measurements

Tim Callahan at Biomedical Systems makes the case for the use of automated algorithms from electrocardiogram machine manufacturers and third-party vendors to ensure consistent, high-quality readings in early phase trials.
 
view
download pdf
bullet
Central Labs
Lab Selection

Balance of Evidence

Central lab partners are often selected based on company policy or previous work, rather than project-specific considerations. A Karelin, M Belotserkovsky, V Khokhlova and A Kumar at PSI set out a process for making the optimal choice.
 
view
download pdf

Interview
Industry Interview

Thinking Allowed

ICT quizzes Rory O’Hare at Greenphire about his concerns over global payments and realising its strategic potential.
 
view
download pdf
   
spacer


Published quarterly in
February, May,
August, and November

News and Press Releases

High Throughput Analytics Herald a Paradigm Shift in the Development of Biopharmaceuticals

Heilbronn/Dortmund August 2019: Biopharmaceuticals have revolutionized therapies of various diseases. In particular with regard to chronical and/or severe clinical conditions like multiple sclerosis, rheumatoid arthritis or cancer they are considered the future of treatment. Also economically biological drugs are on their way up: The global biopharmaceuticals market is anticipated to reach about 400 billion USD by 2025. Which strategic alignment will help best to fill a successful pipeline?
More info >>

White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
More info >>

Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement