Your Success Begins with Elite
“Consulting is the art of turning complexity into clarity, and vision into action—together.”
Original quote: Elite Clinical Data Diagnostics, LLC
About Elite Clinical Data Diagnostics
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Elite Clinical Data Diagnostics (ECDD), LLC offers comprehensive data management services to the CRO, Pharmaceutical and Small Biotech sectors. Our scope includes oversight of data management services, successful oversight of transitional/rescue studies, data vendor qualification audits, SOP creation and documentation, Third Party Vendor management/oversight and general data management consultancy.
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With nearly 60 years of combined experience, the owners have managed clinical data and teams/departments from Phase I to Phase IV, Registry, Observational, and Post-Market studies through study startup (ensuring CDISC compliance), study conduct, and study closure. This experience spans across various therapeutic areas including, but not limited to Oncology, Cardiovascular, Ophthalmology, Rare Disease, Device, and Vaccines.
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Our organization understands the evolution in clinical research data collection where more often critical data is collected through external data sources and therefore brings great experience in handling of external data such as Electronic-Patient-Reported-Outcomes (ePRO), Electronic- Clinical- Outcome- Assessments (eCOA) and critical lab data such as Pharmacokinetic, Pharmacodynamic, local lab data and biomarkers, and the innate complexity in ensuring the integrity of said data. System experience and expertise spans beyond various EDC platforms to other data collection systems and tools such as ePRO/eCOA vendors, Imaging, Rave Safety Gateway, IRT vendors, RTSM and TSDV, enabling the team to provide optimal guidance on system implementation, integration and overall methodologies for clinical trials.
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Elite Clinical Data Diagnostics leverages its experience beyond the data management discipline. Data cannot be managed in a silo. Therefore, our organization offers exceptional collaborative skills, which promote a one team mentality of transparency and respect across the various business units (i.e. Project management, Clinical Operations, Biostats, etc.).
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We are committed to keeping ICH/GCP and GCDH compliance, data integrity and patient safety at the forefront of all we do, managing critical risks and mitigation implementation along the journey.
Our Mission
Our mission is to make our clients stronger and better every day as we support your vision and goals through our offerings and dedication.
Our Values
We believe protecting patient safety starts with high-quality data. By reimagining data structures and streamlining workflows, we enable biotech and pharma organizations to make faster, more informed decisions—accelerating time to market and driving safer, more effective outcomes.
Our Services
Data Management Oversight
We provide strategic oversight of existing, and developing clinical data management teams and processes, ensuring alignment with regulatory standards and study objectives. Our expertise supports both steady-state and rescue study environments, driving quality and consistency across the data lifecycle.
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Strategic oversight of clinical data management from Phase I–IV, Device, Registry or Post approval studies
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Ensuring CDISC-compliant study startup, conduct, and closure
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Facilitating and driving data management activities for rescue/transitional studies through successful handover and robust documentation.
Data Quality & Integrity Consulting
We specialize in safeguarding the integrity of complex clinical data, particularly from external sources such as ePRO, eCOA, and specialty labs. Our consultation ensures that high-quality data underpins every decision, minimizing timeline risk and maximizing patient safety.
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External data handling and system alignment integration expertise (ePRO, Imaging, IRT, Safety, eCOA, PK/PD, biomarkers, and central and specialty labs)
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Data management systems assessment and recommendations
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Proactive risk management assessment and mitigation strategies
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Data integrity assurance across platforms and vendors through metrics and pre-defined KPIs.
Process & Compliance Implementation
We help organizations build and refine data management SOPs, guidance documentation, and operational workflows that meet ICH/GCP and GCDH standards. Our focus on quality-driven processes ensures regulatory readiness and operational excellence at every stage of the trial.
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Collaborative development of data management plans, validation plans, eCRF completion guidelines, third-party reconciliation plans, data finalization checklist, etc.
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Development of data management SOPs and workflows.
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We offer specialized audit services to ensure data vendor qualification, regulatory compliance, and data integrity across clinical trials. Our team conducts thorough audits of data management processes, third-party vendors, and systems, providing actionable insights and recommendations to strengthen quality and mitigate risk.​
Designing a Next-Generation Data Infrastructure
Partnering with you to reimagine the data management organizational structure and necessary skills sets for the future.
This involves rethinking and rebuilding the systems, technologies, and processes that support data collection, storage, integration, governance, and analysis.
The goal is to create a flexible, secure, and future-proof environment that enables real-time insights, supports advanced analytics (like AI/ML), and aligns with business objectives.
Building the Future of Data: Designing a Next-Generation Infrastructure
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CONTACT
Tel: 307.289.4870
Email: info@eliteclinicaldata.com
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