ClinChoice:Your Premier Partner for Investigator-Initiated Studies (IIS)
At ClinChoice, we understand the unique challenges and opportunities associated with Investigator-Initiated Studies (IIS). Our dedicated team of experts is committed to providing comprehensive support tailored to the specific needs of investigators and academic institutions. With our extensive experience and robust infrastructure, we empower investigators to advance their scientific discoveries and achieve successful study outcomes.
Strengths of ClinChoice
- Expert Consultation and Study Design:
- Our seasoned professionals offer in-depth consultation services to help investigators refine their research questions and develop robust study designs.
- We assist with the preparation of detailed study protocols that align with regulatory requirements and scientific best practices.
- Regulatory Support:
- ClinChoice provides comprehensive regulatory support, including guidance on navigating complex regulatory landscapes and obtaining necessary approvals from Institutional Review Boards (IRBs) and Ethics Committees (ECs).
- We facilitate PMDA consultations and ensure compliance with all relevant regulations.
- Feasibility and Site Management:
- Our team conducts thorough feasibility studies to identify optimal study sites and ensure successful patient recruitment.
- We manage site selection, contract negotiations, and maintain strong relationships with leading research institutions and clinical sites.
- Operational Excellence:
- ClinChoice offers end-to-end support for study initiation, including the establishment of research and clinical trial coordination offices.
- We provide seamless management of study logistics, from protocol development to study close-out, ensuring efficiency and compliance throughout the study lifecycle.
- Data Management and Analysis:
- Our comprehensive data management services include case registration, CRF design, data cleaning, coding, and the development of EDC and ePRO systems.
- We prepare high-quality analysis datasets and support investigators in generating robust and reliable results.
- Safety and Quality Assurance:
- We ensure rigorous safety information management and reporting, supporting the establishment of safety committees and effective communication with central laboratories.
- Our monitoring and auditing services include the development of monitoring plans, onsite and offsite monitoring, and comprehensive auditing to ensure data integrity and regulatory compliance.
- Administrative and Financial Support:
- ClinChoice assists with administrative tasks such as jRCT registration, clinical research insurance procedures, and the setup and operation of research portal sites.
- We manage payment processing for research funds, allowing investigators to focus on their research without administrative burdens.
- Central Laboratory Management:
- We offer comprehensive central laboratory management services, ensuring effective coordination and communication with central labs for specimen handling, testing, and reporting.
- Regional Experience:
- Beyond Japan, ClinChoice has a strong track record of successful Investigator-Initiated Studies in other Asian countries, including China, Vietnam, the Philippines, Indonesia, Singapore, India, and Thailand.
- Our regional experience allows us to navigate diverse regulatory requirements and cultural nuances effectively, providing tailored support to investigators across Asia.
Commitment to Excellence
At ClinChoice, we are dedicated to supporting investigators in their pursuit of scientific innovation. Our comprehensive services, expert guidance, and unwavering commitment to quality make us the premier partner for Investigator-Initiated Studies. Together, we can advance medical research and improve patient outcomes by translating innovative ideas into impactful discoveries.
For more information about how ClinChoice can support your Investigator-Initiated Study, please visit our website or contact our team.