Nova Clinical Solutions
NOVA CLINICAL SOLUTIONS, INC. is dedicated to providing efficient clinical research and regulatory services for pharmaceutical and biotech companies worldwide. Founded in 2017, the company focuses on medical device and drug clinical development, offering a wide range of services including clinical trial management, regulatory affairs, quality assurance, and consulting. With a professional team experienced in international projects, NOVA CLINICAL aims to help clients grow their medical product development business, reduce costs, and ensure high-quality clinical data. The company emphasizes a client-centered approach, innovative methods, and strategic partnerships to facilitate successful clinical trials and product approvals in North America and globally.
Industries
Nr. of Employees
small (1-50)
Nova Clinical Solutions
San Diego, California, United States, North America
Services
Services include clinical trial project management, site monitoring, clinical data management, drug safety management, biostatistics/statistical programming, quality assurance and compliance.
Services include protocol and SOP development, pre-IND meetings, IND filing and follow-up, document preparation and submission, IRB/EC correspondence, and informed consent template development.
Advisory services covering GMP and GCP compliance, regulatory interaction and submission strategy, clinical operations planning, and drug safety management.
Outsourced management of overseas clinical programs including CRO and supplier oversight, progress tracking, and handling of urgent operational issues.
Development and maintenance of QMS documentation and processes to comply with GMP or ISO 13485 requirements, and support for inspection readiness.
Partnership arrangements with sponsors, including potential direct investment in drug development projects.
Services include clinical trial project management, site monitoring, clinical data management, drug safety management, biostatistics/statistical programming, quality assurance and compliance.
Services include protocol and SOP development, pre-IND meetings, IND filing and follow-up, document preparation and submission, IRB/EC correspondence, and informed consent template development.
Advisory services covering GMP and GCP compliance, regulatory interaction and submission strategy, clinical operations planning, and drug safety management.
Outsourced management of overseas clinical programs including CRO and supplier oversight, progress tracking, and handling of urgent operational issues.
Development and maintenance of QMS documentation and processes to comply with GMP or ISO 13485 requirements, and support for inspection readiness.
Partnership arrangements with sponsors, including potential direct investment in drug development projects.
Expertise Areas
- Clinical trial management
- Clinical monitoring and patient recruitment
- Clinical data management and biostatistics
- Regulatory strategy and submissions (IND and device registrations)
Key Technologies
- Clinical trial management systems (CTMS)
- Clinical data management platforms / Electronic data capture (EDC)
- Statistical programming for clinical trials
- Quality management system processes and documentation
News & Updates
2017年2月4日，华诺临床作为受邀企业在圣迭戈举行的SABPA前沿论坛上进行了壁报展示，介绍公司情况，获得认可。
2017年3月11日，华诺临床与Syd Labs合作举办系列讲座，介绍药物开发流程、IND申报、临床试验等话题。
2017年10月29日，华诺临床在苏州出席大会，进行临床数据全球首发，参与路演和政策论坛。
2017年11月8-10日，华诺临床在上海参加行业峰会，交流临床开发挑战与机遇，介绍团队和业务。
2017年2月4日，华诺临床作为受邀企业在圣迭戈举行的SABPA前沿论坛上进行了壁报展示，介绍公司情况，获得认可。
2017年3月11日，华诺临床与Syd Labs合作举办系列讲座，介绍药物开发流程、IND申报、临床试验等话题。
2017年10月29日，华诺临床在苏州出席大会，进行临床数据全球首发，参与路演和政策论坛。
2017年11月8-10日，华诺临床在上海参加行业峰会，交流临床开发挑战与机遇，介绍团队和业务。