Full service CRO with Best in Class Partners
MANA RBM offers a full service CRO option for clinical trial implementation and management. Catalyst CR complements MANA RBM in providing a comprehensive, scalable solution using the MANA Method for Risk-Based Monitoring and Remote Trial Management.
The MANA RBM team manages risk assessment, systems selection and design, and designs the reports and data visualizations for trial oversight.
Catalyst CR provides therapeutically aligned monitors for the site interactions as well as additional staff to support administrative functions as needed for the study.
Members of the project team complete both general and study specific training on the MANA Method for RBM and Remote Trial Management.
Other support services for the trial are managed by partners that have worked successfully with our team in the past (e.g. medical monitoring, recruitment, site start up, regulatory, medical writing, statistics).
Contact us to see how our competitive pricing meets your budgetary constraints while providing more quality oversight in the critical areas of subject safety, critical efficacy measures, protocol compliance, Investigational Product Management, and Good Clinical Practice
CRO Quality Oversight
- Quality Oversight of trial conduct is a Sponsor’s Responsibility, regardless of who runs the trials. MANA RBM offers a suite of reports and processes Sponsors can use to assure CROs comprehensively oversee trial conduct and subject safety.
- This suite of quality reports is customized to the specific project or program. We train Sponsors on how to use the reports, interpret the data, and develop a Quality CRO Oversight Plan based on the implementation approach and technology tools used by the Sponsor’s CRO of choice.
- Instead of just sending out monitors to conduct general site visits, Sponsors can optimize their time and budget by using MANA RBM's metrics to identify problem sites, processes, and areas that need additional focus and oversight.
RBM —Knowledge Transfer to CROs or Sponsors
- MANA RBM has designed and implemented an entire process for the adoption of Quality Trial oversight that aligns with the FDA, EMA, and ICH Guidance for Quality Management and Monitoring. If your organization would like to adopt our methods, we provide a two Phase approach.
- Phase I—Work on First Trial(s) as a Team
- MANA leads Risk Identification and Categorization activity
- MANA designs all technology systems and reports
- MANA conducts training on RBM and trial processes
- MANA transfers
- SOPs and Work Instructions
- Training Materials
- Standard Reports
- Customized Subject Profile Analyzing Risk
- Site Level Forms (if needed)
- Monitoring plans, Data and Document Review Guidelines
- MANA performs Co-Monitoring, Co-DM for the first three months
- MANA continues throughout trial with Central monitoring activities
- Phase II—Sponsor or CRO manages trials on their own
- MANA supports any technology design needed
- MANA trains Sponsor or CRO to do Central Monitoring
- MANA licenses all documents, and specifications to Sponsor or CRO
- MANA provides continued access to:
- Lessons Learned
- Study Metrics
- Enhanced process improvement
- Enhanced training