- overview
- our advantages
- ClinDatrix QUALITY
- infrastructure
Our Advantages
What Sets Us Apart?
What differentiates our clinical research services from the others? Why are our clinical trial consultants unique?
- COMPREHENSIVE >> Everything. From beginning to end.
- FLEXIBLE >> What you want when you need it.
- FAST >> Efficient and streamlined.
- FOCUSED >> As dedicated to your clinical trial success as you are.
- COST EFFECTIVE >> High quality clinical research on a reasonable budget.
- EXPERTISE >> The experience and knowledge that you need.
- INTEGRATED >> Collaborative work. Seamless Environment.
- SYSTEMS >> Parallel processing.
- SECURITY >> Validated clinical data management systems environment.
The Experience of BIG.
Our Senior team has 200 plus years of diverse therapeutic experience in the Pharmaceutical, Biotechnology, and Medical Device Industries.
The Advantages of Boutique
We are a champion of quality results, maintaining a focus on your needs only a boutique CRO can offer. All critical operations in clinical trial management, clinical monitoring, clinical data management, biostatistics, and report writing are carefully governed to comply with ICH guidelines and FDA regulations. You will find ClinDatrix's clinical trial services faster, more flexible, more responsive, and less costly than large CROs.
Our comprehensive and complete range of clinical trial services. ClinDatrix can provide and implement multiple or single clinical research services to the biotechnology, medical device, and pharmaceutical industries – locally, nationally or internationally. Partnering with its customers, ClinDatrix applies knowledge and experience to the goals of managing, monitoring, collecting, validating, analyzing, reporting, and delivering quality clinical data with efficiency and accuracy. You may only need a subset of our offerings to accomplish your clinical investigation objectives – perhaps only one – but our flexible customized approach and range of our complementary services are what distinguishes ClinDatrix from other CROs.
Our arsenal of cutting edge clinical investigation capabilities is extensive. It includes a full range of Product Development, Data Management, Biostatistical, Project Management, and Clinical Monitoring services and a host of related complementary processes, systems and standards. The dynamic possibilities, integration, and range of these complementary products and services are what separates us from the rest.
Our focus on quality. ClinDatrix emphasizes quality in all our activities. Using leading-edge management practices, we have implemented systems and processes for ensuring performance excellence. We constantly monitor and measure ourselves against best practice standards. Our fully validated database management system complies with 21 CFR Part 11. Our experienced and knowledgeable personnel, proven systems, established processes, and carefully implemented standards are enforced throughout our organization and ensure extremely high quality deliverables to our customers.
Our integrated capabilities. We don't just offer our clients options. We offer capabilities that effectively work together. At ClinDatrix we apply our knowledge and experience, enhanced by teamwork, speed, and single-minded focus on your project, to the goals of total customer satisfaction and successful completion of your clinical investigation.
Our clinical knowledge. We specialize in clinical investigation management, leveraging our knowledge and years of experience with investigations both large and small, to the goal of delivering quality clinical data. Using our expertise enables our clients to achieve their objectives effectively and expeditiously. Clinical investigations are our passion – it’s all we do.
Our sense of urgency. ClinDatrix is aware of your need for rapid collection, cleaning, and analysis of data, and of the pressing urgency to get your drug or medical device to market. Our technology is a proven performer that enables parallel processing to streamline data processing operations. Combined with our personnel’s expertise and skills, our system accelerates clinical investigations, producing quality data faster, expediting data analysis, and speeding successful protocol completion.
Our people. Our skilled and talented team is comprised of the cream of CRO practitioners, with extensive experience in achieving successful results for clinical investigations of all levels of size, complexity, and scope in the biotechnology, medical device, and pharmaceutical industries.
Our solutions work. Customized data collection and processing strategies are applied to solve each client’s particular needs. Every client is different, every clinical investigation is different, and therefore every solution must be different.
Our expertise. Our experience. A combined 200 years experience in our core team provides the expertise and experience needed to manage a simple or complex clinical investigation and oversee the substantial demands of data collection and processing. We’ve solved real-world clinical investigation problems across protocol designs, therapeutic indications, and geographic boundaries. We've done it successfully for both large and small companies and we can do it for you.
Our emphasis on details. We look at every detail, not merely a general overview, because we know that in clinical research the devil is in the details. We stay actively involved as your partner throughout the entire clinical investigation, providing you feedback on investigation progress and issues as they arise.
Our methodology. Our methodology incorporates a comprehensive quality control program that includes quality control SOPs, < 0.05% error rate for non-critical data, approaching 0% error rate for critical data, tight change controls, peer / managerial reviews, and established signoff's and approvals. We deliver Quality – guaranteed.
Our technology solutions. Our fully validated (IQ/OQ/PQ) clinical database management system provides a secure, parallel processing environment that meets all regulatory agency requirements. Our network infrastructure management includes defined Standard Operating Procedures, backup and disaster recovery planning, software change control, and system validation support.
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