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International Clinical Trials

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Summer 2012
   
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Regulatory & Business Practice
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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PREVIEW

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
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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eCLINICAL, DATA MANAGEMENT & STATISTICAL ANALYSIS
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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Labs & Logistics

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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Reviews
Graham Hughes reviews Principles and Practice of Clinical Research: Third Edition, edited by John I Gallin and Frederick P Ognibene.
 
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Patient Recruitment and Retention
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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Interview
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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Published quarterly in
February, May,
August, and November

News and Press Releases

Cidara Therapeutics Doses First Patient in Pivotal Phase 3 ReSPECT Trial of Rezafungin for Prevention of Invasive Fungal Disease in Patients Undergoing Allogeneic Blood and Marrow Transplantation

SAN DIEGO, Calif. & CAMBRIDGE, England, May 20, 2020 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company developing long-acting therapeutics to transform the standard of care for patients facing serious fungal or viral infections, and Mundipharma today announced that the first patient has been dosed in its ReSPECT pivotal Phase 3 clinical trial evaluating the efficacy and safety of the company’s lead antifungal candidate, rezafungin, for the prevention of invasive fungal disease in patients undergoing allogeneic blood and marrow transplantation (BMT). Rezafungin is a novel, once-weekly echinocandin being developed for both the treatment and prevention of severe fungal infections.
More info >>

White Papers

Is Your Biobank Ready for the Challenge of Biomarker-based Research?

BioFortis

Targeted and personalized studies with well-defined patient segmentation biomarkers are becoming the norm in clinical trials. This increased interest in molecular biomarker studies necessitates a rigor and sophistication in sample management within the clinical trial context that is often not supported either by traditional clinical trial management software (CTMS), or biobanking systems.  Download our Next Generation Biobanking whitepaper and learn about how to overcome the key challenges in clinical trial sample management from working in a distributed network of partners and stakeholder to managing consents and generating scientific insights.
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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 >>

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