Safety Evaluation on Extractables and Leachable

Not all eClinical applications are the same. For one thing, an eTMF, an EDC, and a CTMS all fulfill different functions. Perhaps more importantly, they are all built with varying degrees of complexity. The eTMF and EDC are both relatively simple applications in the IT world. Either can be introduced for a specific study or for a number of studies. If you’re unhappy with your eTMF or EDC applications, you can switch without too much fuss. The CTMS, on the other hand, is highly complex. It is the nerve center of the eClinical suite and is highly integrated with other software. It can be expensive to introduce, and its normal lifespan is more than 13 years. Therefore, once you install a CTMS, you will be committed for well over a decade. That’s why it is so important to choose your CTMS carefully and be armed with the best knowledge in order to do so. Which CTMS concept will be most functional: one where the entire eClinical suite comes from the same vendor or one where individual components are sourced from different vendors?

Following the patent of the innovative “Espresso” intravenous delivery device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a filling line to meet the unique requirements of the solution. Particle Measuring Systems’ advisory team leveraged their industry and regulatory expertise to oversee the development of the aseptic filling process and the environmental monitoring system by applying proven risk management techniques. Using this case study, we provide practical insights for Quality by Design principles with input from IBI and Comecer.

Despite increases in cyber security investment, ransomware remains a persistent threat to healthcare operations. Join Akamai for a discussion on how microsegmentation can prevent adversarial attack methodologies from deployment of the ransomware itself.

Economic performance could soon replace compliance as the leading quality goal for pharmaceutical companies. According to the 2019 Pharma Quality Outlook Survey, 66% of industry executives named compliance as a top goal, down 10% from last year. Meanwhile, more than one-third (39%) say that economic performance is now their top objective, a 4% increase.Join Sparta System's Steve McCarthy, VP of Digital Innovation, as he discusses key findings from this year's survey, which included responses from 161 professionals.