Linical
Linical is a global Contract Research Organization (CRO) based in Japan, dedicated to supporting pharmaceutical and biotech companies in drug development from early clinical trials to post-marketing studies. With a mission to deliver innovative treatments worldwide, Linical emphasizes high-quality, patient-centered research and has a strong global presence, operating in approximately 20 countries/regions and expanding through partnerships to about 30 countries/regions. The company has received various awards and recognition for its contributions to clinical research, innovation, and sustainability. Linical offers comprehensive services including drug development strategy, clinical trial management, pharmacovigilance, regulatory consulting, quality assurance, medical writing, and more, covering all phases of drug development. It specializes in high-difficulty trials in areas such as oncology, neurology, immunology, and rare diseases, and leverages its extensive global network and expertise to support the development of new therapies. Linical also actively publishes research articles, white papers, and case studies, demonstrating thought leadership in the industry. The company values integrity, passion, and curiosity, fostering a diverse and inclusive workplace with a significant international workforce, including employees in Japan, India, and other countries. Linical is committed to sustainability, corporate governance, and creating value for society through innovative clinical solutions.
Industries
Nr. of Employees
large (251-1000)
Services
Strategic planning for clinical development programs, regulatory strategy, dossier preparation and regulatory consulting across development phases.
End-to-end clinical trial operational services including feasibility assessment, study start-up, monitoring, project management, and site oversight for single- and multi-country programs.
Data management operations and statistical analysis services to produce analysis-ready datasets and regulatory-ready outputs including clinical study reports.
Safety surveillance, adverse event reporting and medical affairs support for clinical development and post-marketing activities.
Services and operational models for decentralized trial components and patient-centric data collection using telemedicine, eCOA, remote monitoring and EDC/eTMF solutions.
Implementation and optimization of quality management systems and electronic TMF to support document control, regulatory readiness and faster TMF delivery.
Strategic planning for clinical development programs, regulatory strategy, dossier preparation and regulatory consulting across development phases.
End-to-end clinical trial operational services including feasibility assessment, study start-up, monitoring, project management, and site oversight for single- and multi-country programs.
Data management operations and statistical analysis services to produce analysis-ready datasets and regulatory-ready outputs including clinical study reports.
Safety surveillance, adverse event reporting and medical affairs support for clinical development and post-marketing activities.
Services and operational models for decentralized trial components and patient-centric data collection using telemedicine, eCOA, remote monitoring and EDC/eTMF solutions.
Implementation and optimization of quality management systems and electronic TMF to support document control, regulatory readiness and faster TMF delivery.
Expertise Areas
- Clinical trial management
- Protocol design and drug development strategy
- Regulatory affairs and submissions (EU CTIS/CTR and FDA-focused planning)
- Pharmacovigilance and safety surveillance
Key Technologies
- AI-driven pharmacovigilance and clinical data automation
- Cloud-based clinical data platforms
- Electronic data capture (EDC) systems
- Electronic trial master file (eTMF) systems
News & Updates
Linical marks its 20th anniversary, highlighting two decades of advancing clinical research and patient well-being.
Linical's science-based targets for greenhouse gas emissions reduction have been approved by SBTi, reaffirming its commitment to sustainability.
Linical was awarded as the Best Global CRO 2024 and recognized as a leading international CRO by Global Health & Pharma.
Linical actively participates in international conferences such as ASCO 2024 and the Japanese Society of Gastroenterology, showcasing its expertise and latest developments.
An article discussing the future of sustainability practices in clinical research by Linical.
Explores how artificial intelligence is transforming drug safety monitoring and pharmacovigilance.
Linical marks its 20th anniversary, highlighting two decades of advancing clinical research and patient well-being.
Linical's science-based targets for greenhouse gas emissions reduction have been approved by SBTi, reaffirming its commitment to sustainability.
Linical was awarded as the Best Global CRO 2024 and recognized as a leading international CRO by Global Health & Pharma.
Linical actively participates in international conferences such as ASCO 2024 and the Japanese Society of Gastroenterology, showcasing its expertise and latest developments.
An article discussing the future of sustainability practices in clinical research by Linical.
Explores how artificial intelligence is transforming drug safety monitoring and pharmacovigilance.