ClinDatrix
ClinDatrix is a CRO serving the pharmaceutical, biotechnology, and medical device industries globally. They provide world-class performance and quality at a moderate price, with expertise in clinical trial management, data management, medical safety, biostatistics, medical writing, regulatory affairs, and quality assurance. Their mission is to deliver efficient, accurate data management and support to ensure successful clinical trials, leveraging advanced technology and a highly experienced team.
Industries
Nr. of Employees
small (1-50)
ClinDatrix
Irvine, California, United States, North America
Products
Clinical Trial
Proven and proprietary systems for clinical research designed to ensure the safety and integrity of client data, handling small to large amounts of data and simple to complex study designs.
Clinical Trial Medical Monitor & Medical Safety
Medical monitoring and pharmacovigilance services supporting patient safety and adverse event management in clinical trials.
Clinical Trial Project Management
Comprehensive project management services to guide pharmaceutical, biotechnology, and medical device studies through domestic or global clinical trials.
Clinical Trial Biostatistics
Biostatistical analysis and reporting services designed to ensure studies yield accurate and reliable results.
Clinical Trial Monitoring
Professional clinical trial monitoring services to ensure protocol compliance and data integrity across Phase I-IV trials.
Clinical Trial Investigator Meetings & Event Planning
Planning and execution of investigator meetings and clinical trial related events to support clinical study execution.
Clinical Trial
Proven and proprietary systems for clinical research designed to ensure the safety and integrity of client data, handling small to large amounts of data and simple to complex study designs.
Clinical Trial Medical Monitor & Medical Safety
Medical monitoring and pharmacovigilance services supporting patient safety and adverse event management in clinical trials.
Clinical Trial Project Management
Comprehensive project management services to guide pharmaceutical, biotechnology, and medical device studies through domestic or global clinical trials.
Clinical Trial Biostatistics
Biostatistical analysis and reporting services designed to ensure studies yield accurate and reliable results.
Clinical Trial Monitoring
Professional clinical trial monitoring services to ensure protocol compliance and data integrity across Phase I-IV trials.
Clinical Trial Investigator Meetings & Event Planning
Planning and execution of investigator meetings and clinical trial related events to support clinical study execution.
Services
End-to-end project management for clinical studies including planning, timelines, budget monitoring and sponsor liaison.
Monitoring services at investigator sites to ensure protocol compliance and data quality.
CRF design, validated database setup, data cleaning, edit specifications, and database delivery for clinical studies.
Protocol and statistical design, sample size calculations, SAPs, analysis and SAS programming.
Clinical medical oversight, safety surveillance, adverse event reporting and safety database management.
Regulatory support including eCTD assembly, electronic submissions and regulatory strategy guidance.
End-to-end project management for clinical studies including planning, timelines, budget monitoring and sponsor liaison.
Monitoring services at investigator sites to ensure protocol compliance and data quality.
CRF design, validated database setup, data cleaning, edit specifications, and database delivery for clinical studies.
Protocol and statistical design, sample size calculations, SAPs, analysis and SAS programming.
Clinical medical oversight, safety surveillance, adverse event reporting and safety database management.
Regulatory support including eCTD assembly, electronic submissions and regulatory strategy guidance.
Expertise Areas
- Clinical trial management (Phase I–IV)
- Clinical monitoring and site management
- Clinical data management and EDC
- Pharmacovigilance and medical monitoring
Key Technologies
- Electronic data capture (EDC) systems (on-premises hosting)
- Safety reporting / clinical safety database
- eCTD regulatory submission management
- Secure SFTP file transfer and enterprise collaboration platforms
News & Updates
Collaboration to support multinational clinical trials with local monitoring and centralized technology.
BioGentech partners with ClinDatrix for management and analysis of Phase III clinical trials of Prehistin.
ClinDatrix has formed a consortium with eight CROs worldwide to support multinational clinical trials, providing project management, monitoring, site management, and regulatory guidance.
Utilizing Oracle InForm, ClinDatrix can build electronic data capture databases in just five weeks, significantly faster than industry standards.
Louise M. Murphy and Ned Whittemore earned their CQA certifications from ASQ, emphasizing the company's commitment to quality practices.
Collaboration to support multinational clinical trials with local monitoring and centralized technology.
BioGentech partners with ClinDatrix for management and analysis of Phase III clinical trials of Prehistin.
ClinDatrix has formed a consortium with eight CROs worldwide to support multinational clinical trials, providing project management, monitoring, site management, and regulatory guidance.
Utilizing Oracle InForm, ClinDatrix can build electronic data capture databases in just five weeks, significantly faster than industry standards.
Louise M. Murphy and Ned Whittemore earned their CQA certifications from ASQ, emphasizing the company's commitment to quality practices.