Product Safety/Pharmacovigilance

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    Driving Successful In CNS And Neurology Trials

    Second, only to Oncology, CNS, and Neurology clinical trials are incredibly complex and complicated to navigate.

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    Bioquell Qube Aseptic Isolator

    Create an aseptic workspace with Ecolab’s Bioquell Qube, a configurable isolator integrated with Bioquell Hydrogen Peroxide Sterilant*. From its unique design to rapid turnaround time, the Bioquell Qube provides the aseptic area you need to keep your research or production on track. 

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    Over-Encapsulation/Blinded Study Materials

    Over-encapsulation is a popular, cost-effective technique that involves the blinding of a solid dosage form into a capsule shell in order to eliminate bias from comparative clinical trials, while maintaining study integrity and efficacy. If the blinding of the material is not adequately done, clinical trial participants may be able to tell the difference between the real drug and the placebo, resulting in a biased trial and a loss on your investment.

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    Orphan And Rare Disease CRO Services

    There may be as many as 8,000 rare diseases, affecting between 6% and 8% of the worldwide population in total. It is estimated there are about 30 million affected people in the EU and in North America, while over 45 million people may be suffering from a rare condition in Asia, with 10 million people in China alone.

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    Clinical And Regulatory Strategy

    Many biotechnology companies come to Australia to conduct early phase clinical trials and take advantage of straightforward regulatory streams and of the lucrative 43.5% R&D cash refund scheme. Biotechnology companies then often look at locations in Asia, such as South Korea, Thailand and China to tap into their huge treatment-naïve patient populations for their later phase clinical research.

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Pharmacovigilance/Drug Safety
Pharmacovigilance is also referred to as drug safety. Drug safety is the pharmacological science around the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical substances.
The primary focus of pharmacovigilance is adverse drug reactions. Adverse drug reactions include any response to a drug that is harmful, poisonous or unintended. Unintended consequences can include lack of effectiveness at a therapeutic dosage, overdoses, abuse or misuse of the drug.
Adverse event reporting is the activity most closely associated with pharmacovigilance. Adverse event reporting consumes a significant amount of time. It involves the notification, prioritization, data entry, hazard assessment, distribution, reporting and archiving of the adverse event and all related data and documentation.
In order to improve the outcomes of clinical trials safety and risk management receive greater amounts of resources and money. The pharmacovigilance function is an integral part of creating safety oversight throughout all phases of a clinical trial.  This function requires great efficiency, and a seamless, integrated framework to ensure rapid, early detection and reporting of adverse events, assessment and follow-up.
Clinical trials, with a strong pharmacovigilance process, result in lower surveillance costs during the product development cycle, and enhance patient safety by communicating potential safety issues quickly.  With tight drug safety vigilance in place, problems are identified and addressed quickly; reducing the time it takes to get a product into the marketplace.


The ultimate job of pharmacovigilance is the identification of hazards associated with pharmaceutical products and finding ways to minimize risks or harm to patients.