Navigate rigorous regulatory and evidence demands
Phase 2/3 trials are pivotal in building robust evidence and aligning with stringent regulatory requirements. Kintiga’s expertise ensures your programme meets the highest standards.
The complexity of global regulatory landscapes can challenge even the most prepared teams. Kintiga works alongside you to optimise trial designs, aligning endpoints, comparators and patient-reported outcomes with both clinical and payer expectations.
Our unmatched regional expertise ensures precise guidance on local HTA and regulatory requirements, streamlining submissions and minimising delays.
With proactive insights and meticulous planning, we help you confidently navigate the demands of this phase, laying the groundwork for successful approvals and market entry.
Close the gap on access and uncertainty
We help you:
- Integrate access considerations into clinical trial design
- Build early payer and stakeholder relationships to align trial design, data needs, and reimbursement pathways and integrate expert perspectives into future strategies
- Leverage real-world data to refine trials and support access strategies
- Implement flexible trial designs that adjust to emerging data for increased likelihood of market access success
- Leverage comprehensive health economic evidence that demonstrates the cost-effectiveness of your product
- Develop tailored value dossiers backed by pricing studies to meet payer expectations
Our expertise:
Strategic Advisory
We are your partner in overcoming the complexities of European markets, offering customised solutions to guide you seamlessly through every step of the patient access journey from development and registration through access and launch preparedness.
National Market Access Strategy & Negotiation
Your path to success begins with a clear, well-defined strategy. At Kintiga, we combine local insights with therapeutic expertise to unlock Europe’s healthcare markets.
EU HTA
Our European team expertly navigates the complexities of EU HTA procedures, providing both strategic guidance & comprehensive end-to-end support for JSCs & JCAs at every stage of the process. We are committed to ensuring your products reach patients across Europe efficiently & effectively.
Pricing Strategy
Our experts start with what matters most to access stakeholders and work backwards to develop robust pricing and reimbursement strategies tailored to each market to reflect the value for your product.
Value Communication & Stakeholder Management
We transform complex evidence into compelling, compliant narratives. Through evidence-based storytelling and stakeholder input, we help your product achieve its full potential across diverse markets.
HEOR & Modelling
At Kintiga our expertise in modelling data, outcomes, and costs provides stakeholders with clarity to fully understand the value of treatments, which is vital for healthcare decision making.
Contact us
Contact Kintiga today to ensure your Phase 2/3 strategy sets the stage for market success.
