Students without much exposure tended to shy away from the degree completely. Students, it turned out, were drawn to computer science if they understood what it took to learn and succeed. Nine years later, enrollment in undergraduate computer science …
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The biopharmaceutical (pharma) industry is undergoing major transformation. This transformation is being driven by the changing face of healthcare, characterized by demographic changes, rapid technological developments, and new healthcare expectations, all occurring at the same time as rising regulatory and compliance challenges.
The ability of pharma to respond successfully to these challenges depends on improving the use of information and data. Research by the McKinsey Global Institute estimates that applying big data strategies to improve decision-making could generate up to $100 million in value annually across the US healthcare system. Critical here is by improving their use of information; pharma can improve clinical-trial efficiency, improve collaboration, and use this data to improve their R&D processes. Ultimately this will help pharma find the insights necessary to drive personal or precision medicine, where patients are treated using individualized approaches. However within pharma, one department in particular is currently being dramatically impacted by, as well as tasked with using, insights, and that´s Medical Affairs. |
See this slideshow to learn how real-time tracking strategies can help you keep better tabs on brand awareness and product usage, and see changes in behaviors and perceptions over time.Request Free!
Massive changes are sweeping the health sciences business landscape and are dramatically impacting healthcare and life sciences organizations. To adapt in this dynamic environment, companies must be able to quickly respond to changes in market conditio…
The ability to reach prescribers of your drug or doctors in your therapeutic area is the building block of sound life sciences market research. Find out how InCrowd’s understanding of respect and real-time market research helps you reach physicians and…
You’ll learn who these researchers are, how they work, what they care about at work and where they need help.Request Free!
MasterControl has invested over 240 expert hours into the creation of this CAPA Toolkit that provides all the materials needed to build an efficient, compliant CAPA program.Download to gain access to the following CAPA Management information:Four Webin…
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The management of a Trial Master File (TMF) for a clinical study goes beyond simply managing the creation, review and approval of content that is included in a TMF. Each clinical study brings about its own level of documentation, complexity, collaboration, information exchange, milestones and activities which must be managed as evidence of GCP compliance and the scientific credibility of the clinical study. The ability to manage all of the interactions required by all participants and contributors, such as sponsors, CROs, vendors and study sites in a secure and organized manner ensures the completeness, compliance and “audit readiness” of a clinical trial and Trial Master File (TMF).
The MasterControl eTMF Manager™ is an electronic trial master file management solution designed to enable real-time visibility into the status of all activities pertaining to a clinical study. Based on the TMF Reference Model, the eTMF Manager provides management of all documents, tasks, milestones and activities (such as monitoring visits and audits) required during a clinical trial, while allowing both sponsors and CROs to track the progress of pending, ongoing, and completed actions. |
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Once a standard has reached the Final Draft International Standard (FDIS) stage, comments and objections have been addressed. Each technical reason is addressed in a comments resolution meeting, so that the parties resolve issues before the standard is published. So in effect, the standard has been approved at this point, and only very technical issues would be addressed before its publication.
Accordingly, many companies have a conundrum if they want to maintain both ISO 9001 and ISO 13485 certification: How to comply with the varied requirements within only one quality system. The array of opportunity may not be as broad in terms of rationalizing how to do business as an outlier. In other words this standard is now at a new level of application based on these three points:
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Chromatin Immunoprecipitation is used to examine interactions between protein and DNA within the natural chromatin context of the nucleus. This guide highlights critical steps in an enzymatic digestion ChIP protocol and demonstrates how protocol c…
