Crisis and Disaster Preparedness: Our Solution to Your Challenges

What Have We Learned?

Any emergency or unplanned event requires proactive and prepared leadership to manage a rapidly evolving, unstable situation. This leadership must have a structured, current, and comprehensive disaster preparedness strategy that addresses core mitigation areas.

This leadership must also engage individuals who have a clear command of core Project Management principles to oversee/manage the effort, Process Optimization individuals who can quickly assess, optimize, and create processes, and individuals uniquely skilled in Organizational Change Management to support the rapidly evolving changes ongoing.

 

 

This leadership must also engage individuals who have a clear command of core Project Management principles to oversee/manage the effort, Process Optimization individuals who can quickly assess, optimize, and create processes, and individuals uniquely skilled in Organizational Change Management to support the rapidly evolving changes ongoing.

How We Can Help You

Treximo can use our expertise to support you:

Immediate Crisis/Danger Management and Business Continuity Support

Timing is critical and we are uniquely suited to quickly identify and deploy qualified resources to effectively help you address your crisis using our methodologies:

 

 

Proactive Crisis/Disaster Management and Business Continuity Preparation

We will work with you to assess and enhance your disaster preparedness tools for continued resilience. Our team will utilize our diagnostic tools and deep change/preparedness expertise to support you:

 

 

We understand that emergencies and disasters are emotionally and mentally challenging. It can be incredibly difficult to figure out just where to start and what to complete under a 24-hour, 48-hour, 1 week, and 1-month window. Our Clinical, Quality, Project and Change Management resources are experts, battle-tested, and ready to do just that. We will help you successfully overcome your challenges.

Other Immediate Resources Available

Some areas we have expertise to immediately assist, but not limited to are as follows:

Clinical Operations: Study start-up services, clinical trial management, remote site monitoring

Data Sciences: Conversion of Legacy Data into CDISC datasets, sample size calculations/study analysis design, deep-dive data cleaning

Medical Writing: Protocols (regulatory strategy for trial design + writing), protocol amendments, CSRs, DSURs, QC support, CER writing, Module 2 Summaries, and Investigator’s Brochures

GxP Quality Services: Remediation program management, manufacturing operations/facilities compliance, validation, investigations, assessments, inspection readiness, engineering, DHF remediation, supplier controls.

Regulatory Affairs: Regulatory consulting for INDs, NDAs and BLAs (strategic and/or execution), IND enabling and regulatory plans for new programs, briefing package preparation, and meeting support, regulatory review protocols, CSRs, IND/NDA modules, DSURs.