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International Clinical Trials

Preserving Trial Integrity During a Pandemic


The pharmaceutical industry is being impacted by the COVID-19 pandemic in ways not seen before. From decreased recruitment rates due to enforced social distancing policies, to a complete halt in drug development programmes as companies project their budgets. Trials are not being run as usual, and the pandemic’s effect on ongoing clinical trials may threaten scientific accuracy and regulatory compliance. However, with the correct changes and statistical methodologies in place, a study’s integrity can be preserved.

Sample Size: Are We Good or Not?

The right sample size ensures a successful study while balancing costs and minimising the number of patients undergoing potentially invasive procedures. We might think of continuing as planned until normality is restored, however, the costs of running a study that doesn’t deliver results in the agreed timelines can be overwhelming for major pharma companies, and a killer for smaller biotech companies.

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About the Author

Karen Ooms is responsible for overseeing the strategic delivery business unit for Quanticate. This includes the supervision of the clinical data management, biostatistics, programming, medical writing, and pharmacovigilance departments. Karen is a Chartered Fellow of the Royal Statistical Society and has a background in biostatistics spanning over 25 years. Prior to joining Quanticate in 1999 (Statwood), Karen was a senior statistician at Unilever.
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News and Press Releases

New laboratory and regulatory services for biotech customers

USA/Germany, September 21, 2020. Gerresheimer adds essential laboratory and regulatory services to its broad portfolio of products, solutions and services for biotech companies. Specialized laboratory technicians and an experienced team of further specialists offer these services in the two innovation and technology centers in Bünde (Germany) and Vineland (New Jersey/USA). Gx Biological Solutions offers full service for biotech companies regarding product development of primary packaging and drug delivery solutions, material and functional testing as well as comprehensive regulatory support. The partnership with Gerresheimer shortens the time to market for pharmaceutical companies, minimizes risks and saves resources.
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White Papers

Pharmaceuticals and Healthcare Products

Turkish Cargo

Pharmaceuticals are requiring safe and reliable transportation for being highly temperature sensitive products. Thosepharmaceuticals are; diagnostics, vaccines drugs, sera, plasma, protein clinical trials, biotechnological material, pills and all kind of medicines. Turkish Cargo transports all kind of pharmaceuticals, and has been carrying out its operations of transporting and storing drugs and temperature-sensitive medical supplies successfully and with the experience of 80 years; since 1936.
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Industry Events

World Vaccine Congress Europe

18-21 October 2020, Barcelona, Spain

The World Vaccine Congress is an award-winning series of conferences and exhibitions that have grown to become the largest and most established vaccine meeting of its kind across the globe. Our credibility is show through the prestigious scientific advisory board that spend months of hard work creating a new and topical agenda, year on year.
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