- Home
- / Your journey /
- Phase I
Phase 1
Phase I is a critical milestone where safety and proof-of-concept data build the foundation for success
Turn challenges into progress
Phase I trials are more than a safety milestone—it’s the blueprint for success in every phase ahead.
Kintiga helps you craft clinical trial designs that not only align with today’s requirements but also anticipate the demands of future phases. By addressing scalability early, together we can ensure your program is built to adapt and thrive as it progresses.
Through tailored guidance, proactive risk mitigation, and a collaborative approach, we bridge gaps in resources and expertise, empowering you to focus on advancing confidently to Phase II and beyond.
Build confidence in your data and secure stakeholder buy-in
We take the burden off your shoulders by advising on Clinical Trial Applications (CTAs) and offering hands-on support for FDA INTERACT sessions and similar early consultations.
Our team work closely with you to design trials that not only meet regulatory expectations but also generate reliable safety data that stakeholders trust.
Strategies to address market access challenges in Phase 1 include:
- Early collaboration with regulatory bodies, streamline market access and identify potential concerns.
- Partnering with patient advocacy organisations to boost awareness and facilitate patient recruitment
- Establishing programs to safely provide access to investigational drugs for patients with limited treatment options
- Designing Phase 1 trials with a strong focus on safety and data collection to maximise evidence generation for future market access applications
- Engaging experts and aligning with key opinion leaders to understand market needs, helping you craft a narrative that inspires confidence
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.
