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MANA RBM Thanks Innovator Sponsor, PaxVax

May 6, 2016: Clinical Informatics News Publishes Details of Knowledge Transfer of Comprehensive Risk Based Quality Management Approach for Trial

By Penny Manasco - May 13, 2016

MANA RBM would like to acknowledge the innovative thinkers at PaxVax for embracing the FDA and EMA Guidance on Risk Based Monitoring (RBM) and adopting an approach that meets the FDA and EMA Guidance and the Comprehensive Risk Based Quality Management envisioned in the ICH draft Guidance.  
The Knowledge Transfer to PaxVax from MANA RBM was the focus of an article released May 6 in Clinical Informatics News. “We were thrilled to work with such a collaborative, forward-thinking Sponsor organization”, said Penelope Manasco, M.D., CEO, MANA RBM. 
PaxVax is running a trial for 900 subjects using a small, internal team with only Central Monitoring Support from MANA RBM after the systems and processes were set up and PaxVax and the Sites were trained. PaxVax was able to identify and correct issues rapidly and focus their review on the critical data and processes identified during Risk Assessment.
Caroline Finlay, project manager for PaxVax noted, “the Risk Assessment helped us to design our trial processes to minimize the risk of missing important data from the research subjects.  Tools such as the Subject Profile Analyzing Risk (SPAR) {A MANA RBM proprietary product} helped our monitors to evaluate each subject’s profile of all critical data in minutes, remotely. We also benefited from adopting an electronic Investigator Site File and electronic Trial Master File, which MANA RBM developed for us using a cost effective “off the shelf” product.”
In addition to helping companies with Knowledge Transfers to adopt the ICH’s recommended Comprehensive Risk Based Quality Management including RBM, MANA RBM offers a Do It Yourself Option so companies can adopt and implement the new GCP requirements efficiently and quickly. This option includes all SOPs and Work Instructions, Plan Templates, Technology Plans and Specifications, and training. For more information, please contact Penelope Manasco, M.D. at 919-556-9456.