The European Medicines Agency (EMA) unveiled the European Union (EU) Clinical Trial Regulation (CTR) to replace the current Clinical Trial Directive (CTD) as the overarching legislation for conducting clinical trials in the EU.
We listen to your immediate concerns and needs.
- "How is EU CTR different from the EU CTD regulation?"
- "What requirements need sponsor preparation and action?"
- "Do sponsors develop new processes or update existing ones?"
- "What are the impacts to current business and system processes?"
- "What system updates are necessary for compliance?"
- "What data and documents are impacted and to what degree?"
- "How do we ensure resources are ready for the change?"
- "Which functional areas are impacted?"
EU CTR Focus Areas
Our Subject Matter Experts (SMEs) understand the eight key focus areas.
- CTIS: User, Access and Application Management
- CTIS APPLICATION MANAGEMENT: Types, Interdependencies, Timelines, Notifications, RFIs
- APPLICATION PRE-REQUISITES: Medical product registration in OMS, SMS and xEVMPD
- APPLICATION SUBMISSION: Results and Clinical Study Reports Submissions
- SAFETY REPORTING: Types, Changes to submission of Annual Safety Report
- DATA & DOCUMENTS: Mapping to golden sources, transformation and submission
- SYSTEMS ADAPTATIONS: Clin. and Reg. systems fields, configuration and upgrades for CTR
- TRANSITION OF ONGOING TRIALS: Planning and critical aspects for transition to CTR
Red Nucleus Solution
Developed an exhaustive implementation charter defining the following elements:
- Defined overall enterprise model and governance
- Documented roles, responsibilities, and key activities
- Defined immediate next steps required for internal and external stakeholders
- Identified documents and data ownership, availability and transformation required
- Defined Path Forward to Achieving Regulatory Compliance
- Established Governance, Roles, and Responsibilities