MakroCare Launches “RBMready”, specialized Consulting & Advisory Services
Makrocare announced the launch of “RBMready” specialized Consulting & Advisory Services for Risk-Based Monitoring (RBM) to support biopharmaceuticals and medical device companies in their endeavors to adapt RBM approach. After issuance of the guidance document by FDA and EMA as well, the drug & device development companies are actively embarking on this paradigm shift in clinical research.
Announcing about these services, Mahesh Malneedi, President mentioned “under RBMready MakroCare offers advisory services on structuring processes and people alignment along with the necessary technology changes.”
Ashok Ghone, VP- Global Services added “MakroCare’s RBM specialists not only can advise but also will do detailed blue-print of the processes needed for sponsors to take full advantage of RBM benefits effectively. All this is done while ensuring high quality and integration of data, enhancing subject protection, reducing cost and eliminate inefficiencies across clinical trial process.”
MakroCare’s process and system experts in RBM will also leverage its proprietary framework – ClinicalMetanoia. This framework helps clients get to real time data and analyze results with appropriate analytics by utilizing sponsors’ already existing infrastructure as much as possible. Where needed, additional tools and applications are suggested that can integrate with sponsors’ systems well and enhance the value of the data that is already being generated by sponsors (or their partners’ systems).