Optimizing Monitoring in clinical trial

Centralized Monitoring (CenMon) As complexities of clinical trials, have been increasing significantly in last few years; it is becoming challenging for life science companies to manage and monitors their projects, programs to ensure right conduct and obtain desired quality and integrity of the data which is appropriate for regulatory submission within planned timelines and budget.

MakroCare’s Centralized Monitoring approach – CenMon offers a smarter, reliable and cost-efficient way to monitor various aspects like RISKS, CLINICAL, SAFETY, QUALITY and also supports OVERSIGHT of their trial, program or project. By aligning right customized processes, robust technology and trained resources, CenMon helps sponsor to take real control of their projects, vendors/CRO and cost.

• Helps in early identification and control of risks to trials, projects & vendors
• Keeps track of sites’ performances to plan timely corrective actions
• Facilitates oversight of CROs/CRAs performance and helps in bringing higher efficiencies
• Supports in better monitoring of patient safety and helps in enhancing subject protection
• Optimizes on-site monitoring visits and thereby reduces related cost
• Helps to ensure achievement of overall quality, timelines and budget
• Builds overall cost-efficiencies in clinical trial operations and ensures high ROI

• Risk-based, strategic clinical monitoring approach for phase I-III trials/program
• Oversight of overall trials, programs, projects and vendors/CROs
• Phase IV, observational & registry Studies (Late-Phase Studies)
• Pivotal medical device studies