Services
Aurora Clinical specializes in guiding international biopharmaceutical companies through the complexities of Japan’s regulatory and clinical development landscape. Aurora’s services are tailored to facilitate seamless integration into the Japanese market, ensuring compliance, efficiency, and strategic alignment with global objectives.
In-Country Clinical Caretaker (ICCC) Services
Act as a local representative, supporting companies without a physical presence in Japan. The ICCC responsibilities, as required by Japan Good Clinical Practice (J-GCP), include regulatory submissions, liaising with the PMDA, and overseeing clinical trial activities to ensure compliance with Japanese regulations.
Regulatory Strategy and Consultation
Navigating Japan’s regulatory environment requires expertise and local insight. Aurora Clinical offers comprehensive regulatory consultation services, including:
- PMDA Consultations: Facilitating formal interactions with PMDA to gain endorsement of development strategies.
- Clinical Trial Notifications (CTNs): Preparing and submitting CTNs in accordance with Japanese requirements.
- Orphan Drug and other Designation Applications: Assisting in the preparation and submission of applications for Orphan Drug, Sakigake and Special Use status.
Strategic Key Opinion Leader Engagement and Asset Awareness
We facilitate targeted engagement with influential Key Opinion Leaders (KOLs) in Japan to maximize awareness and credibility of clients’ assets. Together with our clients, we develop strategic approaches to define the unmet medical need, effectively communicating the therapeutics’ value, driving adoption and support throughout the clinical and commercial lifecycle.
Clinical Development Planning and Implementation
We provide end-to-end support for clinical development in Japan, encompassing:
- Study Design and Protocol Development: Crafting study designs that meet both global standards and local expectations.
- Site Selection and Management: Identifying and managing clinical trial sites across Japan.
Vendor Oversight: Coordinating with local vendors to ensure quality and compliance.
Pharmacovigilance
Our pharmacovigilance services ensure continuous safety monitoring and compliance with local regulatory requirements. We manage safety reporting, risk management plans, and periodic safety updates to protect patients and maintain regulatory integrity.
Market Analysis and Pricing
Through our close collaboration with Aurora Partners, we offer comprehensive market research, including assessments of target product profile, treatment and competitive landscapes, reimbursement pathways and pricing strategies. We leverage deep market insights to develop optimal positioning and pricing structures tailored specifically to the Japanese market.
Facilitation and Negotiation with Japanese Licensing Partners
Also, through Aurora Partners, we can support international companies in identifying, engaging, and negotiating with suitable Japanese partners. With our extensive local network and negotiation expertise, we ensure favorable and sustainable partnerships that drive long-term success.