International Clinical Trials |
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Prescription Drug User Fee Act
Navigating the Initiatives
Nina Baluja,
George R Hemsworth, Mehri Hezari-Adam, Pat Mann and Henrietta Ukwu at
PPD explain how the changes in the Prescription Drug User Fee Act will
affect pharmaceutical and biotechnology companies in terms of cost and
timeframes. |
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Clinical Research Training
Raising the Bar
Precise training strategies help to ensure that clinical research professionals are equipped to perform well in the workplace, explains Martin Robinson at the International Academy of Clinical Research.
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Partnerships in Clinical Trials Europe
Adapting to Change
Learn about
strategic and practical approaches to enhancing relationships between
trial sponsors and their suppliers at this upcoming event in November. |
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Industry Interview: Lotus Labs
The Road to Madrid
Dr Yati Chugh talks to
ICT about the clinical research scene in India, and what he is looking
forward to at ICSE. |
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Showcase: ICSE
Event Preview Ready for Business?
Get ready to network
and learn at the ICSE event in Feria de Madrid, taking place in October. |
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Editor’s Comment
Graham Hughes notes how the clinical trials world is increasingly patient-centric in its approach. |
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Regional Trials: India
Shining Light
Apurva Shah at Veeda Clinical
Research and Ashish Kumar Dasgupta of the Association of Contract
Research Organizations discuss how revisions to regulatory processes in
India are transforming the appeal of conducting clinical trials in the
subcontinent. |
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Regional Trials: China
Betting Big
As China becomes an increasingly
important player in the pharma industry, Nick Stephens of RSA speculates
on the changes that will occur in terms of R&D. |
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Patient-Centric Trials
Drug Development 2.0
Tomasz Sablinski of
Transparency Life Sciences investigates new trial design elements that
are shaping the future of drug development, including crowdsourcing,
data transparency and telemedicine. |
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Mobile Technology
Capturing the Patient’s Voice
Judith Teall at Exco
InTouch explains how mobile technology is driving a more patient-centric
approach to late phase research. |
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Measurement-Based Care
The Patient as an Individual
Stephen Webb at
REGISTRAT-MAPI North America shares his thoughts on the developments
that are occurring in the healthcare industry and examines whether
measurement-based care can improve outcomes for patients and reduce
costs. |
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Serious Adverse Events Reporting
Safely Does It
Knowledge regarding
serious adverse events is crucial in the process of clinical
development. Rick Morrison at Comprehend Systems describes how new data
visualisation and statistical analysis software can improve the accuracy
of reporting |
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Monitoring Data Management
Doing More with Less
Richard Young at
Medidata Solutions delves into risk-based monitoring – an area that is
being changed and modernised through a series of new technological
breakthroughs. |
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Statistical Analysis
Non-Response: Issue or Inconvenience?
Missing data
may pose a problem for those carrying out clinical trials, but as Andrew
Grannell at Statistical Solutions explains, non-response may actually
be able to contribute additional information to studies. |
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Logistics: South America
Right Place, Right Time
Angus Macleod at
Catalent Pharma Solutions assesses the importance of taking the
differences in regional regulations into account when importing clinical
trial materials. |
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Partnering with Central Labs, ECG and Imaging Labs
Outsourcing
Strategies
Graham Hughes reports from Partnering with Central Labs, ECG
and Imaging Labs – an Informa Life Sciences Conference held in Brussels.
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Global Sample Management Benchmarking Symposium
Strategic Sample Management
Graham Hughes provides a round-up from an information-packed symposium that was organised by Biostorage Technologies, and sponsored by ICT.
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Graham Hughes reviews Principles and Practice of Clinical Research: Third Edition, edited by John I Gallin and Frederick P Ognibene.
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Study Recruitment: Social Media Feasibility Model
Status Update
The
trend for using social media platforms to recruit patients for clinical
trials is on the rise. Before embarking on this approach, Rahlyn Gossen
at Rebar Interactive outlines the importance of a feasibility model,
based on an assessment of the patient, the organisation’s ability, and
the budget available |
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Patient Engagement
Bring it Online
Finding ways to actively engage the
patient in a clinical trial has proved to be far from straightforward
exercise. Aaron B Fleishman at BBK Worldwide shows how social media
tools can be employed to raise awareness of the science behind the
clinical research. |
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Industry Interview: Thinking Allowed
Maria V Lopez-Bresnahan of PharmaNet/i3 talks to ICT about her clinical trials experience, and what the future holds for the industry.
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