I: Initiate – Build a Strong Foundation for Success
Define a Clear PICO Early:
IMAC senior consultants collaborate with multidisciplinary advisory boards to establish a clear, well-structured, and actionable PICO (Population, Intervention, Comparator, Outcome) framework from the very beginning. A robust PICO ensures alignment across all phases of your submission.
Engage Local Experts to Tailor Strategies:
To address the nuances of varying healthcare systems across EU member states, IMAC consultants gather insights from local clinicians, health economists, and regulators. This ensures your strategy is responsive to the diverse expectations of HTA bodies.
Foster Collaborative Alignment Across Stakeholders:
IMAC consultants prioritize early and continuous stakeholder engagement, creating a shared understanding among all key players. This collaborative foundation helps anticipate and address potential challenges from the outset.
M: Manage – Execute with Precision and Clarity
Conduct a Comprehensive Systematic Literature Review (SLR):
IMAC consultants lead a thorough, systematic review of the evidence. Starting with a broad and inclusive search strategy, they capture all relevant clinical and economic data to meet the requirements of the EU Joint Clinical Assessment (JCA).
Refine the Evidence Using a Tailored PICO Approach:
Throughout the process, the SLR is refined and continuously aligned with the PICO framework. This ensures the evidence collected is not only comprehensive but also directly relevant to submission objectives.
Proactively Address Complexities:
IMAC consultants navigate the intricate regulatory landscape with precision, helping you manage tight timelines, diverse requirements, and cross-country expectations to ensure your submission stays on track.
A: Adapt – Stay Agile in a Dynamic HTA Landscape
Implement a Living SLR to Stay Current:
To ensure your submission remains relevant, IMAC uses a living SLR approach. This dynamic process allows for regular updates and refinements as new clinical or economic evidence emerges.
Respond to Challenges with Strategic Agility:
IMAC consultants are equipped to handle unforeseen hurdles, such as shifting guidelines, evolving clinical standards, or new comparator data. Their ability to adapt ensures your submission strategy remains on course.
Maintain Flexibility to Meet Evolving Requirements:
As HTA regulations and expectations evolve, IMAC ensures your strategy is responsive without sacrificing long-term goals. Consultants remain proactive in integrating new insights to meet both EU and local requirements.
C: Continue – Ensure Long-Term Success Across HTA Submissions
Prepare for Country-Specific HTAs with Precision:
Leveraging insights from the EU JCA process, IMAC consultants support future submissions to individual country HTA bodies. This ensures a seamless transition from centralized assessments to local ones.
Maintain a Continuity of Evidence and Insights:
IMAC consultants ensure that the evidence base, insights, and strategic momentum built during the EU JCA process are sustained and efficiently applied to local HTA submissions.
Deliver Expert Guidance for Future-Ready Submissions:
IMAC’s senior consultants offer unparalleled expertise and leadership to ensure your submission strategy remains effective. They equip your team with actionable insights and a roadmap for success in a dynamic regulatory landscape.