Archive for February 2011
Case study: NextDocs for SharePoint. (information provided by the Vendor)
The challenge for the company was the manual process of finding, capturing, reviewing, approving, and storing documents for regulatory agencies. There was no consistent process for managing this task, no central document repository, and no significant automation.
They began searching for a document management solution designed to meet the needs of Life Sciences companies. This solution needed to comply with recognized standards, had to be easy to use by employees in many locations, and had to fit in with the company’s IT strategy.
Sanofi Pasteur MSD deployed the NextDocs Document Management System. Using Microsoft SharePoint Server as a foundation, the NextDocs solution provides a powerful document management, workflow, and collaboration solution that meets FDA 21 CFR Part 11 requirements.
Sanofi Pasteur MSD executives wanted a single solution that would provide company-wide regulatory compliant document management. That meant an FDA 21 CFR Part 11 compliant solution and that authorized users could access easily and consistently, from any location around the world. Furthermore, no additional management or administrative burdens could be placed on the company’s small IT department.
Sanofi Pasteur MSD uses Microsoft SharePoint Server for internal sharing and collaboration, so it wanted to find a standards-compliant document management solution that would leverage that investment.
Using built-in workflow and collaboration tools, the NextDocs software automated key tasks, including:
• Routing documents for review
• Reminding signatories when they needed to review and approve documents
• Capturing digital signatures
• Saving the final approved versions of the documents in a standard PDF format
• Storing these documents in a secure yet easily accessible data repository
The NextDocs Regulatory Document Management Module is a complete solution for managing documentation needed for CTD/eCTD and related filings in a SharePoint based system.
NextDocs guides users through the production of submission ready documents by enforcing the use of CTD/eCTD required granularity, requiring templates, producing PDF renditions that meet the myriad of agency requirements, and collecting 21 CFR Part 11 compliant electronic signatures.
Info challenges for researchers today and predict for the future, by the senior vice president, market development at ProQuest, interviewed by Sian Harris in Research Information.
“The core content needs of researchers today have not significantly changed over time. Researchers still need access to high-quality scholarly journal articles, A&I databases and books, as well as primary sources like data sets, historic newspapers and documents. (…)
However, what has really changed is the way that researchers need to find, access and use content.
Researchers expect that content will be delivered to them electronically, when they want it, where they want it and in a format they can use. As new electronic platforms like mobile devices and e-readers emerge, publishers need to adapt our content for these devices. Also, as the amount of available electronic content increases, researchers need to be assured that they have located everything that is relevant to their research.
Users are much more confident in their abilities to find and use information. (…)
We have seen that researchers are beginning to adopt the same search habits that they are using on consumer sites like Amazon, Google and Facebook. They tend to enter fewer search terms and expect to be able to narrow their results after the search.
Researchers also expect to be able to do more with content once they find it. Sharing content is becoming more prominent.
One big challenge is navigating the sheer volume of material that is available to researchers. They can never be assured that they have found all of relevant material for their research needs.
I think information resources will become more personalised for researchers’ needs. I can envision tools that will push content of interest to researchers based upon the content that they have searched in the past or articles that they have looked at and rated highly.
There will be more opportunities for researchers to network and share content with their self-defined group of peers. I can see information resources that provide spaces for collaboration and interaction with fellow researchers.
Sauer-Games, Mary. Working with changing patterns. Research Information, February/March 2011.
This study reports evidence consistent with the ‘deliberate fraud’ hypothesis. The results suggest that papers retracted because of data fabrication or falsification represent a calculated effort to deceive. It is inferred that such behaviour is neither naıive, feckless nor inadvertent
Authors of fraudulent retracted papers appear to target journals with a high Impact Factor.
The results of this study show unequivocally that scientists in the USA are responsible for more retracted papers than any other country.These results suggest that American scientists are significantly more prone to engage in data fabrication or falsification than scientists from other countries.
The idea that certain authors may be deliberately trying to deceive should make journal editors and general readers profoundly cautious.
Grant Steen. Retractions in the scientific literature: do authors deliberately commit research fraud? J Med Ethics 2011;37:113-117. http://jme.bmj.com/content/37/2/113.abstract
The famous science writer David Bradley has 10,000 followers…
Anyway, what he says is
“I also know that at the core there are a few dozen friends and contacts with whom I regularly trade tweets and links, with whom I direct message (DM) and with whom I even have conversations via email, messaging, SMS, the phone and even in the real world.
It’s entertaining, it’s a chance to share what you know and learn about what you don’t. It’s a chance, vaguely, to earn a crust. It’s not really about the numbers.
While every follower matters, there are only a limited number that count”.
Bradley, David. Count envy, satisfaction and achievement. ScienceBase, posted on February 11, 2011.
With his world map of scientific collaboration, Oliver Beauchesne, from the US-Canada based Science-Metrix, has built nice visualizaion of science collaboration.
It is based on Scopus data. For those interested in looking at how scientists are connected geographically, a number of companies already promise to help map the geographic reach of an individual or a discipline. These include Springer’s AuthorMapper, Transinsight’s GoPubMed and BioMedExperts.
Van Noorden, Richard. Picture post: world map of scientific collaboration. The Great Beyond (Nature), Posted on January 27,2011.