At the 2018 DIA Annual Meeting in Boston, one of the topics I heard a lot of discussion around was China. Once known as a low-cost producer of generic drugs and pharmaceutical APIs and excipients, the country is now stepping up the quality and timeliness of its manufacturing to attract the attention of pharmaceutical companies.
The industry is ready to communicate the shared patient experience in a continuous flow from discovery through to marketing.
Over the last four years, the U.S. Medical Operations group of Novartis Oncology — in collaboration with internal clinical partners — has been transforming the study startup process for Novartis-sponsored studies.
The FDA’s RMAT and breakthrough designations have created a streamlined environment for product sponsors. To effectively leverage this regulatory policy environment, sponsors must conduct high-quality clinical trials that are often operationally complex. Clinical trial networks, capable of managing the array of regenerative medicine technologies, are well suited to manage this complexity.
How a cloud-based SSU Solution with a SaaS-based platform manages the complexities of study activation.
While many vendors are claiming agile IRT capabilities, it is important to dig deeply and examine these claims – as well as a company’s proven ability to provide predictable, consistent delivery of project timelines and quality.
Implementing eSource can mean operating differently from the norm, with potentially an initial layer of complexity before things become simpler.
Regulations continue to evolve globally within the distribution arena of the Life Sciences industry. There is an increased focus on companies being able to prove the quality and integrity of their drug product throughout the entire clinical supply chain.
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Five considerations to help organizations make better planning and forecasting decisions in an environment with such strict parameters.
Familiarize yourself with the new FDA draft guidance on blood pressure response which carries important implications for drug developers.
How the use of tools can enable your objective of ensuring patient safety by having the right amount of material available with an appropriate investment in inventory cost.
With spiraling costs and increasing stakeholder demands, it’s critical that studies get off to the right start.
Workflow-based technology coupled with executive authoritative power encourages process optimization in the clinical trial continuum, helping to break down silos, enhance operational performance and ensure quality in the electronic trial master file.