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WHITE PAPERS

BioFortis

phone +1.443.276.2464
email info@biofortis.com
web http://www.biofortis.com
email 10320 Little Patuxent Pkwy, Suite 410, Columbia, MD 21044

Is Your Biobank Ready for the Challenge of Biomarker-based Research?

Targeted and personalized studies with well-defined patient segmentation biomarkers are becoming the norm in clinical trials. This increased interest in molecular biomarker studies necessitates a rigor and sophistication in sample management within the clinical trial context that is often not supported either by traditional clinical trial management software (CTMS), or biobanking systems.  Download our Next Generation Biobanking whitepaper and learn about how to overcome the key challenges in clinical trial sample management from working in a distributed network of partners and stakeholder to managing consents and generating scientific insights.
Is Your Biobank Ready for the Challenge of Biomarker-based Research?
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News and Press Releases

Clinical and Regulatory Operational Excellence Forum

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not?
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White Papers

Clinical Trial Labelling More Than Just Labels

Faubel & Co. Nachfolger GmbH

Deciding which label is best for a particular trial project is not always easy. Labels have become multifunctional tools which are able to convey variable data in different languages, indicate first opening, product originality, support ease of use or blind study drugs. They are no longer used as mere carriers of specified contents.
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Industry Events

Clinical Trial Supply Europe 2019

13-14 March 2019, Milan, Italy

Following on from our largest and most engaging meeting to date, Clinical Trial Supply Europe will be returning to Milan for its 20th year in 2019! The 19th annual edition welcomed pharmaceutical companies across Europe who got together to share knowledge and issues regarding clinical trial supplies, both with regards to operational and technological challenges. Over the two days, delegates discussed issues which affected their business in our dedicated operational and technological streams.
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