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Clinical Trials in Cyberspace


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Dr Jennifer Riggins
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Dr Sandra Blumenrath
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News and Press Releases

Genome & Company Chooses Luina Bio to Supply Innovative Drug Productfor Clinical Trials Programme

Luina Bio, a leading biopharmaceutical manufacturing company in Australia, today announced it will develop and produce an innovative bacterial drug product for Genome & Company to support its clinical trials programme. The relationship signals Luina Bioís first foray into Asia and further establishes its global leadership in the current Good Manufacturing Practise for microbiome projects.
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White Papers

Key to Outsourcing Method Development and Validation: A Pragmatic Approach

RSSL

In an industry that is seeing an increasing level of work being outsourced, the Contract Research Organisation (CRO) of choice needs to have proven experience in both the pragmatism and flexibility of the method developerís mind set and a regulatory background in validation. As companies are focussing on achieving ever shorter times of drug to market, it is vital that a tailored, pragmatic approach is adopted when engaging in both method development and validation activities for an Active Pharmaceutical Ingredient (API) or drug product (DP). Although methods still require a high degree of robustness, the overall strategy should encompass a full evaluation of the regulatory requirements applicable to the particular phase of the drug life-cycle; this is pivotal in Key to Outsourcing Method Development and Validation A Pragmatic Approach order to ensure a successful regulatory submission, where the applicant must demonstrate suitable validation of all methods used to support the filing.
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Industry Events

10th Annual Summit for Clinical Ops Executives

18-21 February 2019, Hyatt Regency Orlando, Florida

Celebrating its 10th successful year, SCOPE Summit 2019 takes place February 18-21 in Orlando, FL. Over the course of four stimulating days of in-depth discussions in 19 different conferences, 3 plenary keynote sessions, and the ever-popular interactive breakout discussions, the programming focuses on advances and innovative solutions in all aspects of clinical trial planning, management and operations, including...
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