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International Clinical Trials

Out of Control

The first documented outbreak of the Ebola virus disease – more commonly known as Ebola – occurred in 1976 in South Sudan and the Democratic Republic of the Congo. Nearly 40 years later in 2013, the most widespread outbreak of Ebola in history started in the West African country of Guinea and quickly spread to the neighbouring countries of Liberia and Sierra Leone.

While previous outbreaks were brought under control within a matter of weeks, this one became an epidemic that raged on for over two years, resulting in more than 11,000 deaths and significant social disruption. A number of factors contributed to the failure to control this flare-up, including extreme poverty in the affected areas; a dysfunctional healthcare system in affected countries; a population with enormous distrust of government officials after years of armed conflict; several months of delay in government agency response to the outbreak; and the unprecedented spread of Ebola to densely populated cities.

Even with previous Ebola epidemics on record, there were no licensed vaccines, no treatments with proven efficacy in humans and no diagnostics that met the WHO’s target product profile for a rapid, simple Ebola virus disease test at the start of this spread. The lack of effective treatments, combined with the severity of the breakout, triggered an unprecedented global response to tackle the epidemic that provides a compelling case study for accelerated drug development models.

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goBalto’s Chief Executive Officer Sujay Jadhav has over 20 years of experience with leading Silicon Valley software providers with a life sciences focus. Most recently, he was Senior Vice President of Global Corporate Strategy and Development at Model N, and held a variety of roles in Strategy Consulting at Booz Allen Hamilton, Product Strategy at CommerceOne and General Management at Singapore Telecom. Sujay received his Bachelor’s degree from the University of South Australia and an MBA from Harvard University, US.
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SKYCELL ANNOUNCES GLOBAL COLLABORATION WITH AIR FRANCE KLM MARTINAIR CARGO

Zurich, Switzerland / Schiphol, Netherlands / Roissy Charles de Gaulle, France, April 2, 2019 – SkyCell, the Swiss-based manufacturer of the world’s safest temperature-controlled containers for pharmaceuticals, and Air France KLM Martinair Cargo will expand their existing collaboration. Therefore, both companies have announced a global collaboration to work more closely together on existing and future business in logistics of pharmaceuticals.
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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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Industry Events

World Pharma Week 2019

17-20 June 2019, Seaport World Trade Center, Boston

World Pharma Week will bring together a unique and international mix of large and medium pharmaceutical and biotech companies, CROs, leading universities and clinical research institutions, emerging companies and tool providers—making it a perfect meeting-place to share experience, foster collaborations across industry and academia, and evaluate emerging technologies.
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