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International Clinical Trials

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Spring 2013

   
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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.
 
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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.
 
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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.
 
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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.
 
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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.
 
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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.
 
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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?
 
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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.
 
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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.
 
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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.
 
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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.
 
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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.
 
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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.
 
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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.
 
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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.
 
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Interview
Industry Interview

Thinking Allowed

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

Strategic Alliance to support efficient, ethical practices in biopharma industry

Hayward, CA and Stockholm, Sweden (07-12-2017) – Two leading drug development and regulatory consultancies announced today that they have formed a new strategic collaboration to help life science companies navigate an increasingly complex global environment. Ethiprax Associates LLC, a leading Compliance and Ethics solutions consultancy based in the US, and NDA Group, a world-leading integrated regulatory/drug development consultancy, are now collaborating to provide the life science industry with truly integrated, trans-Atlantic Compliance-and Risk Management strategies.
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

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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