Clinitude
Provider of clinical trial services and consultancy focused on integrating remote monitoring, site support and adaptive operational solutions. Headquartered in Belgium with offices in the US and the Philippines, the company offers clinical operations, data management, regulatory submission support and project management with experience across oncology, immuno‑oncology, neurology and medical device studies.
Industries
Nr. of Employees
medium (51-250)
Clinitude
Chicago, Illinois, United States, North America
Products
CLIN-360°
Flexible operational support solutions providing hands-on support across the entire clinical trial lifecycle, including full-service execution or targeted functional support to streamline operations while maintaining compliance and quality.
Clinitude Integrated Site Support (CIS²)
A flexible, high-performance remote site support model tailored to meet the needs of academic research institutions, independent sites, and site networks, providing proactive, real-time support to boost site performance, reduce site burden, and accelerate study timelines.
CLIN-Integrity: QA as a Service
Clinitude's QA services ensure clinical trials meet the highest ICH-GCP & ISO14155 standards and are fully inspection-ready, supporting quality systems with practical, risk-based solutions.
CLIN-TELLIGENCE
A division within Clinitude dedicated to building AI and software tools that help clinical trial professionals work smarter, faster, and with greater confidence.
Oracle Clinical One
A unified platform by Oracle Life Sciences for advanced data collection, randomization, and trial supply management (EDC & RTSM) capabilities, used by Clinitude to streamline clinical data management services and maximize operational output.
CLIN-Vision
Clinitude's dedicated central monitoring team designed to strengthen clinical oversight, reduce risk, and ensure data integrity by serving as a bridge between data managers, CRAs, and sites.
CLIN-360°
Flexible operational support solutions providing hands-on support across the entire clinical trial lifecycle, including full-service execution or targeted functional support to streamline operations while maintaining compliance and quality.
Clinitude Integrated Site Support (CIS²)
A flexible, high-performance remote site support model tailored to meet the needs of academic research institutions, independent sites, and site networks, providing proactive, real-time support to boost site performance, reduce site burden, and accelerate study timelines.
CLIN-Integrity: QA as a Service
Clinitude's QA services ensure clinical trials meet the highest ICH-GCP & ISO14155 standards and are fully inspection-ready, supporting quality systems with practical, risk-based solutions.
CLIN-TELLIGENCE
A division within Clinitude dedicated to building AI and software tools that help clinical trial professionals work smarter, faster, and with greater confidence.
Oracle Clinical One
A unified platform by Oracle Life Sciences for advanced data collection, randomization, and trial supply management (EDC & RTSM) capabilities, used by Clinitude to streamline clinical data management services and maximize operational output.
CLIN-Vision
Clinitude's dedicated central monitoring team designed to strengthen clinical oversight, reduce risk, and ensure data integrity by serving as a bridge between data managers, CRAs, and sites.
Services
Centralized liaison and remote monitoring services that integrate with CRA activities to improve monitoring efficiency and site relationships.
CRA services including site initiation, monitoring visits, protocol training and targeted SDV focused on patient safety and data quality.
Design and implementation of study databases, CRF design, edit checks, reporting and adjudication support.
Preparation, review and compilation of clinical trial regulatory dossiers and submission documents aligned with ICH‑GCP and local regulations.
Project planning, risk assessment, budget and resource management, and program oversight to deliver clinical studies on schedule and on budget.
Feasibility assessments and selection services to identify sites with adequate patient populations, facilities and motivated investigators.
Centralized liaison and remote monitoring services that integrate with CRA activities to improve monitoring efficiency and site relationships.
CRA services including site initiation, monitoring visits, protocol training and targeted SDV focused on patient safety and data quality.
Design and implementation of study databases, CRF design, edit checks, reporting and adjudication support.
Preparation, review and compilation of clinical trial regulatory dossiers and submission documents aligned with ICH‑GCP and local regulations.
Project planning, risk assessment, budget and resource management, and program oversight to deliver clinical studies on schedule and on budget.
Feasibility assessments and selection services to identify sites with adequate patient populations, facilities and motivated investigators.
Expertise Areas
- Clinical trial management
- Site monitoring and site management
- Remote central monitoring and RBM
- Clinical data management and database programming
Key Technologies
- Remote central monitoring
- Risk‑based monitoring (RBM)
- Clinical Trial Management Systems (CTMS)
- Electronic Trial Master File (eTMF)
News & Updates
Announced participation in BIO International Convention 2025 (Boston, June 16‑19).
Announced participation at AACR 2025 in Chicago to present site support and oncology trial solutions.
Planned participation in an oncology site solutions summit in Atlanta (April 9‑10, 2025).
Described a strategic collaboration to strengthen clinical data management and analytics capabilities using cloud‑based vendor solutions.
Reported that a global study with over 37,000 patients closed recruitment one month ahead of schedule, attributed to integrated remote monitoring and CRA liaison approach.
Reported reduction of overall monitoring costs by approximately 60% through introduction of a liaison‑based remote monitoring model while maintaining data quality.
Announced participation in BIO International Convention 2025 (Boston, June 16‑19).
Announced participation at AACR 2025 in Chicago to present site support and oncology trial solutions.
Planned participation in an oncology site solutions summit in Atlanta (April 9‑10, 2025).
Described a strategic collaboration to strengthen clinical data management and analytics capabilities using cloud‑based vendor solutions.
Reported that a global study with over 37,000 patients closed recruitment one month ahead of schedule, attributed to integrated remote monitoring and CRA liaison approach.
Reported reduction of overall monitoring costs by approximately 60% through introduction of a liaison‑based remote monitoring model while maintaining data quality.