samedan logo
 
 
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
Edited by
Dr Graham Hughes
Consultant in
Pharmaceutical
Development

Published quarterly in
February, May,
August and November

News and Press Releases

Lifesharing Safeguards Donated Tissues and Organs with Reliable Temperature Monitoring & Alarming


More info >>

White Papers

Achieve full compliance with tamper-verification pharma solutions

UPM Raflatac

UPM Raflatac has developed a range of pharmaceutical labelling products to support compliance with the Falsified Medicines Directive on packaging for prescription drugs and high-risk, over-the-counter medicines. Few solutions offer the same ease of adoption for meeting the February 2019 deadline.
More info >>

Industry Events

BioPharm America™ 2017—10th Annual International Partnering Conference

26-27 September 2017, 39 Dalton Street, Boston, MA 02116

BioPharm America™ is a unique partnering event that forms the nexus of discovery and realization. Startup companies, established biotech and entrepreneurs from academia attend in search of finance, pharma and development partners.
More info >>

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement