Archive for February 2011
Regulatory documentation management at Sanofi
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.
http://www.nextdocs.com/en-us/Case%20Studies/Sanofi-Pasteur-MSD-Case-Study.pdf
Info Searchers? Info Consumers? Info Collaboraters?
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.
http://www.researchinformation.info/features/feature.php?feature_id=309
More fraudulent papers in high Impact-Factor publications
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
Twitter: Followers are not always Friends!
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.
http://www.sciencebase.com/science-blog/count-envy-satisfaction-and-achievement.html
Doctors and Social Media: conference in Paris in June
Doctors 2.0™ & You, a first-time conference examining how doctors use social media and Web 2.0 tools to connect with patients, colleagues, pharma, payers and hospitals, will be held on June 22-23, 2011 at the Cite Universitaire Internationale in Paris
The Doctors 2.0 & You agenda will shed light on topics such as appropriate social networking, physician acceptance and resistance to adopting new tools, and relevant business models, facilitating debate and information exchange via workshops, panels, interactive exhibits and social events.
The conference will gather physicians, physician and patient communities, online and mobile tool providers, hospitals, insurers, pharmaceutical companies and government entities.
Bibliometrics can be fun!
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.
http://blogs.nature.com/news/thegreatbeyond/2011/01/picture_post_world_map_of_scie_1.html
SERMO: a successful SN for american physicians
as reported into the Deloitte study.
With 117,000+ members (1 in 5 practicing US physicians), Sermo is the largest online community of physicians, where MDs nationwide discuss drugs and devices, exchange clinical insights and collaborate on difficult cases.
Physicians discussing difficult cases, sharing insights about drugs/devices and working together to improve patient care.
Almost half of physicians use Sermo as much as or more than Google to obtain medical information.
Physicians are interested in interacting with life sciences companies on physician social networks.
Sermo could substitute for sales representative visits and in-person educational events —even for doctors who limit sales reps.
Physicians would welcome life sciences company interactions on Sermo.
Sermo already uses KOL from the industry.
Big Pharmas remain cautious using social media
A recent survey by Deloitte shows that big pharmas are still relunctant to engage massively into social media.
The use of social networks has exploded over the past few years:
- one in three Americans research their condition online use social networks
- 60% of physicians are using or are interested in using social networks for professional purposes
- SERMO, the dedicated SN for physicians, is a real success
Anyway, life sciences companies lag firms in other industries in their social networks presence. Only 11% of Pharmaceuticals Fortune100 are on Facebook; 33% have blogs; and 22% are on Twitter.
Currently, half of surveyed life sciences professionals do not have plans to use social networks.
Reasons are:
#1 Respondents perceive lack of regulatory guidance (from FDA) as the biggest barrier to adoption
#2 Patients’/consumers’ wish for privacy
#3 Lack of demonstrable Return on Investment
To Friend or not? New insights about social networks in the Life science industry. Deloitte, white paper. Dec. 2010. Online:
http://www.deloitte.com/view/en_US/us/Industries/life-sciences/eb84853b4eb0d210VgnVCM3000001c56f00aRCRD.htm
