IDMP
Let us help you to get IDMP ready
We recognize that compliance with IDMP requirements is a huge challenge for Life Sciences companies increasing the workload on already-stretched regulatory resources. On the other hand, IDMP presents a unique opportunity for substantial long-term improvement of regulatory operations.
That’s why we’ve created a 4-step process to guide you on the journey to IDMP compliance and beyond. Step by step we help you identify where you are in relation to IDMP readiness, and we chart and manage your journey for you.
Benefits
Inspired by our vision, guided by industry consultants and professionals
Our approach draws on the industry experience, insight and learnings, distilled through our IDMP Customer Circle into emerging IDMP common practices.
Let’s get started together on your IDMP acceleration program!
Kick off your IDMP Health Check today
Our consultative IDMP health check is the ideal way to get started. Together we look at some key questions about your IDMP journey.
- Where are you right now with IDMP?
- What are your biggest pain points?
- What type of support do you need most?
Your path to IDMP success starts here: Book a 1:1 Health Check today
Amplexor 4-Step IDMP Journey
Following your IDMP health check results, we’ll onboard you at the step that best reflects where you are on your IDMP journey.
1. Awareness
- IDMP resources
- IDMP events
- IDMP induction training
✔ I know what IDMP requires
2. Preparation
- IDMP impact assessment
- IDMP data preparation
- IDMP project preparation
✔ I have my IDMP implementation plan
3. Implementation
- IDMP solution implementation
- Legacy data transformation
- Initial IDMP data load
✔ I have my IDMP solution in place
4. Production
- In-process IDMP data enrichment
- IDMP data validation
- IDMP data submission
- IDMP data maintenance
- Regular solution updates
- Continuous process optimization
✔ I have full IDMP compliance and business benefits
Kick Start Your IDMP Journey Today
You’re Safe In Our Hands
Deep expertise
- Internal consulting team with senior industry background
- Deep knowledge of regulatory guidelines and direct involvement in the design and development process
- Strong partner ecosystem for extensive consulting engagements
Rich experience
- Industry leadership on XEVMPD – first solution on the market with largest share of gateway submitted records
- Engagement in IDMP since ISO IDMP standards publication
- Proven track record on complex data migrations and integrations
Customer relations
- Customer circle community of industry experts promoting constructive exchange of IDMP information
- Customer-driven design through direct input and feedback that shapes the IDMP functionality
Long term benefits
- The target operating model will fundamentally change regulatory operations, enabling better quality and shorten the time to market for the benefit of the patients
- The standardization of data and processes will significantly contribute to improve operations along the entire value chain
How Our Life Sciences Suite Covers Holistic IDMP Needs
Ease of compliance
- Our ProductExpert™ IDMP solution is a seamless part of the end-to-end RIM user experience in a familiar user interface
Data-centric processes
- IDMP is driven by a common master and reference data model shared across the complete Life Sciences Suite
- Interconnected data model enables transparent and efficient data-driven change management process
- Improved granularity of structured data brings new potential for automated content creation and other business benefits
Data connectivity
- Flexible connectors allow configurable connectivity to external data sources
- Integrated support for AI-based IDMP data extraction
- SPOR interoperability drives external alignment on reference sources
- Serve as a central regulatory data hub for your wider company needs
- Built-in B2B gateway enables direct submission of FHIR messages
Process connectivity
- IDMP target operating model is a natural part of the end-to-end regulatory information management where IDMP message is submitted together with eCTD sequence
- Regulatory activity planning & tracking drives both data and content components of the regulatory submissions
- Direct connection to the submission management capabilities enables automated inclusion of FHIR messages in eCTD sequences
Ease of implementation
- Upgrade path from existing RIM and XEVMPD implementations, leveraging and transforming existing data
- Plug&Play solution for new customers on premise or in the cloud with full support for data migration
Future-proof design
- Configurable data, content and process model allows for simple adjustment to emerging requirements, evolving processes and emerging common practices
- Regular product releases bring new or enhanced solution capabilities in a frequent pace
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