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Sparking Innovation

Today, human factors engineering, computational fluid dynamics, clinically relevant in vitro testing, sophisticated drug discovery and clinical trial designs are common. These and other advances offer the promise of better drugs delivered from devices that more patients can use intuitively and correctly. Such rapidly evolving methods allow international pharmaceutical companies to bring new products to market, and create openings for startup businesses. As the complexities of in vitro-in vivo correlations and bioequivalence are ironed out, the viability of systemic, nose-to-brain and sinus delivery are explored, and thermal aerosols threaten to go mainstream. It is reasonable to imagine that nasal and pulmonary drug delivery will become the portals by which biotechnology-derived products enter the body without a needle, and other drugs are delivered with unparalleled efficiency.

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News and Press Releases

Turkish Cargo maintains its steady growth.

According to the data obtained by WACD, the international air cargo information provider, in May; Turkish Cargo, the global air cargo brand providing service to 124 countries around the world, increased its tonnage rate by 7.1 percent, and grew substantially across the industry which shrank by 5.1 percent in the global air cargo market.
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White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
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