By design, ClinDatrix fills a critical need for pharmaceutical, biotechnology and medical device innovators who are advancing their products. We offer the expertise and systems of a large CRO with the attention and guidance sponsors deserve.
The Experience of Big
Our operations team managers have more than 200 combined years of diverse therapeutic experience in the pharmaceutical, biotechnology and medical device industries. We offer product development, project management, clinical monitoring, medical safety, data management, biostatistics, medical writing, regulatory affairs and quality assurance services. We provide and implement single or multiple clinical research services locally, nationally or globally while overseeing the substantial demands of data collection and processing. Using the same systems as large CROs, we address real-world clinical investigation challenges across protocol designs, therapeutic indications and geographic boundaries.
The Advantage of Value
At ClinDatrix, we offer capabilities that work effectively together. We specialize in clinical investigation management, leveraging our knowledge and expertise to deliver quality clinical data. We stay actively involved throughout our clients’ clinical investigations, providing feedback on investigation progress and issues as they arise. Drawing on our expertise, our clients achieve their objectives effectively and expeditiously. ClinDatrix is flexible, responsive and less costly than large CROs – and the uncompromised quality and value we deliver has ensured us many long-term clients.
ClinDatrix Is Different
Our people. Our skilled and talented team offers extensive experience in achieving successful results for clinical investigations of all levels of size, complexity and scope.
Our solutions. We customize data collection and processing strategies to satisfy each client’s particular needs. Our fully validated (IQ/OQ/PQ) clinical database management system provides a secure, parallel processing environment that meets all regulatory agency requirements. Our regulatory submissions systems work together to enable project team members anywhere in the world to collaborate and share critical documents via a web browser – and to achieve seamless management of electronic submissions to worldwide regulatory agencies. Further, our network infrastructure management includes defined standard operating procedures, backup and disaster recovery planning, software change control and system validation support.
Our focus on quality. ClinDatrix emphasizes quality in all our activities. We continually monitor and measure ourselves against best practice standards. Our experienced and knowledgeable personnel, proven systems, established processes and carefully implemented standards are enforced throughout our organization to ensure high quality deliverables to our clients.
Our differentiators
Comprehensive >>Everything. From beginning to end.
Flexible >>What you need. When you need it.
Fast >>Efficient and streamlined.
Focused >>As dedicated to your success as you are.
Cost Effective >>Big quality on a reasonable budget.
Expertise >>The experience and knowledge you need.
Integrated >>Collaborative work. Seamless environment.
Systems >>Parallel processing.
Security >>Validated systems environment.