The Experience of Big. The Advantage of Value.®
ClinDatrix is a contract research organization (CRO) that serves pharmaceutical, biotechnology and medical device industry clients globally. Founded in 2002, ClinDatrix works with small to medium-sized companies on projects ranging from simple Phase I proof-of-concept studies to multinational pivotal Phase III studies and post-marketing studies. Our experience enables us to guide our clients through the regulatory and development processes – and our repeat business demonstrates that we are a valued partner.
From our inception, the ClinDatrix vision has been to offer a full range of world class project management, clinical monitoring, data management, medical safety and regulatory affairs 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 Safety – ClinDatrix medical monitors work in collaboration with the investigator sites to provide patient safety oversight. Services include processing reported SAEs and preparing concise and accurate narratives and reports to regulatory agencies.
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.
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 CSRs 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 sponsors.
Consulting – Clindatrix experts from any of our service areas can be contracted on a consulting basis. Further, we offer medical device engineering expertise to assist with design history files, technical files and quality systems. Our network of pre-clinical product development experts can guide emerging companies from R&D to product testing.