The Experience of Big. The Advantage of Value.®
ClinDatrix is a privately held, full-service contract research organization (CRO) founded in 2002 to help drug and medical device innovators advance their therapeutic products toward regulatory approval. Over the past decade, ClinDatrix has grown to offer contract research expertise from preclinical development guidance through regulatory filings and post-marketing studies. We continue to work primarily with small to mid-sized companies, which is a subset of biomedical innovators that we know and serve very well. We also are a reliable resource to large pharma and medical device companies seeking to outsource specialized tasks for timely completion.
From our inception, the ClinDatrix vision has been to offer a full range of world-class project management, clinical monitoring, medical safety, data management, biostatistics, medical writing, regulatory affairs, and quality assurance capabilities. Through our network of U.S.-based consultants and global affiliates, we are a trusted choice for firms conducting trials domestically or around the world.
Our core strengths enable us to guide our clients so that their studies yield clean, reliable data. Our workflow processes and procedures are governed by a full suite of SOPs that are compliant with GCP, ICH, and FDA guidelines. Our equipment and systems, which include Oracle Clinical, Oracle RDC Onsite, Oracle Argus Safety, LORENZ docuBridge eCTD submissions, and SharePoint/Montrium document management are fully validated. Everything we do, from protocol review and CRF design to database setup and regulatory submissions, helps advance our clients along their product development pathways.
Clinical Project Management – Our project management services include protocol review, investigator selection and recruitment, site evaluation, investigator meetings, onsite training and more.
Clinical Monitoring – From site initiation to closeout, ClinDatrix clinical research associates (CRAs) monitor the protocol implementation, data collection, regulatory document maintenance, and a battery of clinical study performance metrics.
Medical Monitoring and Patient Safety – From site initiation to closeout, ClinDatrix clinical research associates (CRAs) monitor the protocol implementation, data collection, regulatory document maintenance, and a battery of clinical study performance metrics.
Data Management – Through the application of quality processes and standards – and project-specific data management documentation – we produce accurate clinical databases for analysis and reporting. We use Oracle RDC to enable our clients to harness the power of global EDC for the most complex clinical trials.
Biostatistics – Our statisticians and statistical programmers provide a full range of statistical services including sample size calculations, randomization schedules, blinding and unblinding procedures, statistical analysis plans, and statistical analyses.
Medical Writing – From protocol development to clinical study reports and regulatory documents, ClinDatrix medical writers ensure clear written communications with sites, investigators, and regulatory agencies throughout the product development process.
Regulatory Affairs – ClinDatrix offers a full range of global regulatory services for pharmaceuticals, biologics, and medical devices, ranging from simple advisory capacity to preparation and submission of IND, NDA, BLA, IDE, and 510(k) filings, including eCTD format (Lorenz docuBridge software).
Quality Assurance – ClinDatrix offers independent auditing of clinical investigator sites or other service providers as requested by our clients. Through these services, we can assist you in your due diligence activities as well as preparations for regulatory audits.
Preclinical Development Consulting – Through the ClinDatrix Preclinical Development Consortium, we tailor teams of experts to help our clients manage the preclinical development and regulatory aspects of their innovative drug, medical device, or diagnostic projects.
Other Consulting Services – Clindatrix experts from any of our service areas can be contracted on a consulting basis. Our event planner offers proven Investigator Meeting planning expertise. Further, we offer medical device engineering expertise to assist with design history files, technical files, and quality systems.
Adverse Event Management/Software, Clinical Trial Monitoring, Consulting, Data Management, Electronic Data Capture, Electronic Submissions Preparation, Medical Writing, Protocol Development, Regulatory Affairs/Regulatory Strategy, Statistical Services/Meta Analysis