Technology & automation drive operational efficiencies across the PV continuum

We are all aware that what we know of Pharmacovigilance today will radically transform in the future with the use of automation and technology tools. Companies that implement these tools in their PV operations can experience greatly improved efficiency, compliance and quality.

The impact and use of social media in pharmacovigilance

Pharmacovigilance (PV) has evolved and grown more complex over the past 5 to 10 years due to increasing data volumes, evolving regulations, influence of emerging markets and the emerging social media and innovative technological advances. Digital media is now used by biopharmaceutical companies for communication with patients to create awareness about diseases and treatments, clinical trial enrollments and patient support programs. It presents new channels and methods that can enable companies to move away from traditional PV systems and safety reporting methods towards more patient-centric models for reporting, analyzing and monitoring of safety data.

Drug discovery is not black and white—why should Your studies be?

Medical imaging is a powerful tool that allows for in vivo and ex vivo quantification of various endpoints which can aid in oncology research and drug discovery. With a myriad of imaging options, how do you know which method is the most appropriate for your needs? The purpose of this blog is to bring clarity to the use of several preclinical imaging modalities available.

Progress in treating chronic Kidney Disease patients with Cardiovascular Disease: Kidney Health Initiative develops clinical research recommendations

Throughout the world, kidney disease is far more common than most people realize. It’s not a stretch to call it a “hidden epidemic,” as the number of people living with kidney disease (850 million) is roughly twice that of those living with diabetes.(1)

Building awareness with National Diabetes Month and new T2DM treatment guidelines

Coinciding with National Diabetes Month is the recent publication, Management of Hyperglycemia in Type 2 Diabetes, 2018. A Consensus Report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD), which contains the most up-to-date, impactful set of new treatment guidelines for patients with Type 2 diabetes mellitus (T2DM).

Mining real-world data with cutting-edge analytical tools: helping to achieve patient recruitment targets

In 1848, the most famous Gold Rush in American history began at Sutter’s Mill near present-day Coloma, California, shaping the US economic map forever. In those days, there were no scientific tools to guide prospectors in their search. Sites of previous finds were the starting point for what became, for many, a shattered dream.

Inflammatory bowel disease clinical studies – where do we go from here?

Inflammatory bowel disease (IBD), incorporating Crohn’s disease (CD) and ulcerative colitis (UC), is a chronic relapsing-remitting inflammatory disorder of the gastrointestinal tract.1 There is currently no cure for IBD and available treatments (e.g. aminosalicylates, immunosuppressant, biologics) have variable degrees of efficacy and tolerance. As a consequence, there is a large focus upon the development of new drugs for the treatment of IBD. While this is undoubtedly a welcome fact for patients and their families, the current level of research activity brings logistical challenges when conducting clinical trials.

Designing a comprehensive drug discrimination study

Regulatory agencies require that any drug (parent or major metabolite) that penetrates the brain and has CNS activity, regardless of its therapeutic indication, be assessed for that drug’s abuse potential. In this series on Assessing Abuse Potential, we are sharing how we design and setup accurate and valid nonclinical GLP abuse liability study types required by regulatory agencies: self-administration, drug discrimination and physical dependency.

How a no-deal Brexit might affect medical device development: legal consequences and risk mitigation strategies

Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario.

ISO 14155 update: key risk management changes for medical device clinical investigations in 2019

The third edition of the ISO 14155 standard for medical device clinical investigations is expected to be published in 2019. It could be published as early as this spring and probably arrive no later than mid-year.