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International Clinical Trials

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Spring 2012

   
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Dr Graham Hughes reflects on the importance of clinical trial sample storage.

 
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Regulatory & Business Practice

Quality Oversight Programmes

High Standards

Third-party quality oversight programmes provide sponsors with an impartial assessment of their study, which can help to reduce costs and ensure regulatory standards are being met, as John R Wilson Jr at Beaufort, LLC discusses.

 
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Medical Devices

Off to Market

Karen Lunde and Stephan Joeken of CERES, Clinical Evaluation & Research share their thoughts on how best to compile a clinical investigation report to gain CE approval for a medical device.

 
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Cancer Drug Development

Data is King

Todd Clark at Value of Insight Consulting explains how the requirements of the FDA approval process can aid the development of cancer drugs by gathering information on endpoints, timelines, populations and safety results.

 
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Clinical Trial Management

Clinical Trial Management

Efficient Beginnings

The development of comprehensive risk and contingency plans, as well as sound communication plans, is essential when setting up a global clinical trial, as Kellie Malloy at PharmaNet/i3 explains.

 
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Clinical Trial Outsourcing

Outsourcing

The Art of Listening

Maintaining an equal and open relationship between sponsor and service provider can help ease the clinical trial process and encourage innovation, as Andy Thurstan of MD Events explores.

 
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eCLINICAL

Electronic Document Management Systems

Know Your Numbers

Rhonda J Paz and Diandra Nuno-Salcido of GuideStar Clinical Trials Management suggest how the formation of a regulatory document can benefit from adopting the right electronic document management system.

 
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Clinical Trial Applications

Submission Statement

Helle Ørbæk and Lillan Rejkjær of IWA Consulting explain how electroniccompatible clinical documentation provides an efficient and cost-effective method for submitting regulatory documents.

 
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Clinical Trial Supply & Packaging

Clinical Trial Labelling

Designer Label

Global clinical trials pose considerable challenges to the labelling process. Pernille Smith of CCL Label Healthcare discusses the methods being employed to overcome these difficulties.

 
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PREVIEW

Phase 1 and 2a Clinical Trials

Graham Hughes reviews the key presentations on proof of concept and venture capitalism at the London conference.

 
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Sample Management Strategy

Learn how successful sample management can help support the development of new therapies at the Global Sample Management Benchmarking Symposium.

 
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Regional trials

Regional Trials: South-East Asia

SEA Power

Kenneth Lee and Helen Neal at PRA consider the growth of clinical research in South-East Asia, and suggest that understanding the unique challenges of the region is essential.

 
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Hardware Fulfilment

Tools of the Trade

Karen Harley of Bracket and Christopher Nightingale describe how knowledge of local restrictions and regulations is critical when shipping hardware for a clinical trial, helping to prevent costly delays to the study.

 
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Central Labs

Central Laboratories

Rising to the Challenge

As the clinical research sector expands and trials become increasingly complex, central laboratories must learn to adapt to new pressures, as Graham Hughes and Richard Barrett, Consultants in Pharmaceutical Development discuss.

 
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Metrics Champion Consortium

From Evolution to Revolution

Guy A Mascaro of the Metrics Champion Consortium explains the role that the organisation is playing in helping sponsors to improve the clinical research process.

 
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Trial Design

Adaptive Designs: Early Phase Trials

Keys to Successful Design

Denis Gossen and Dominique Demolle of Aepodia explain how, with adequate planning, adaptive trial designs in early phase research can help to improve accuracy and efficiency.

 
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Patient Recruitment and Retention

Post-Marketing Research

Planting the Seed

Post-marketing research (PMR) is growing in importance, with regulatory authorities increasingly requiring studies that confirm the ongoing safety of a newly-approved drug. Thomas Wagner of Trilogy Writing & Consulting advises on how to design a successful PMR plan.

 
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Patient-Friendly Trials

Home is Where the Trial is

Home trials can be difficult to set up, but Graham Wylie of the Medical Research Network suggests that these studies are worth the risk as they offer considerable benefits to patient recruitment and retention.

 
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Interview

Industry Interview

Thinking Allowed

ICT talks to Steve Cutler of ICON Clinical Research Services about his views on the clinical trials industry and how it might develop in the future.

 
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Published quarterly in
February, May,
August, and November

News and Press Releases

IMFINZITM (durvalumab) WITH CHEMOTHERAPY DEMONSTRATED A SUSTAINED OVERALL SURVIVAL BENEFIT IN 1ST-LINE EXTENSIVE-STAGE SMALL CELL LUNG CANCER IN THE PHASE III CASPIAN TRIAL

Detailed results from an updated analysis of the Phase III CASPIAN trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin, demonstrated a sustained, clinically meaningful overall survival (OS) benefit for adults with extensive-stage small cell lung cancer (ES-SCLC) treated in the 1st-line setting.
More info >>

White Papers

Syringe siliconization

Gerresheimer AG

Ready-to-fill, i.e. sterile, prefillable glass syringes, are washed, siliconized, sterilized and packaged by the primary packaging manufacturer. They can then be filled by the pharmaceutical companies without any further processing. These days the majority of prefillable syringes are made of glass and the trend looks set to continue. The siliconization of the syringe barrel is an extremely important aspect of the production of sterile, prefillable glass syringes because the functional interaction of the glass barrel siliconization and the plunger stopper siliconization is crucial to the efficiency of the entire system. Both inadequate and excessive siliconization can cause problems in this connection. The use of modern technology can achieve an extremely uniform distribution of silicone oil in glass syringes with reduced quantities of silicone oil. Another option for minimizing the amount of free silicone oil in a syringe is the thermal fixation of the silicone oil on the glass surface in a process called baked-on siliconization. Plastic-based silicone oil-free or low-silicone oil prefillable syringe systems are a relatively new development. Silicone oil-free lubricant coatings for syringes are also currently in the development phase.
More info >>

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.
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