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
10 South West Loop, Riverside Plaza, Suite 875, Chicago, Illinois, 60606, United States
Products
CLIN-Integrity
Quality assurance services ensuring clinical trials comply with ICH-GCP and ISO14155 standards through quality system setup, audits, and training.
CLIN-Insights
Strategic consulting for clinical trial design, regulatory compliance, risk management, and operational efficiency.
CIS² (Clinitude Integrated Site Support)
Remote site support services to assist clinical trial sites with patient recruitment, data entry follow-up, query resolution, and site documentation.
CLIN-Vision
Central monitoring service providing remote data surveillance, risk-based monitoring, query oversight, and site performance analysis.
CLIN-360°
Flexible operational support across clinical trial lifecycle including regulatory submissions, project management, site management, and data management.
CLIN-Integrity
Quality assurance services ensuring clinical trials comply with ICH-GCP and ISO14155 standards through quality system setup, audits, and training.
CLIN-Insights
Strategic consulting for clinical trial design, regulatory compliance, risk management, and operational efficiency.
CIS² (Clinitude Integrated Site Support)
Remote site support services to assist clinical trial sites with patient recruitment, data entry follow-up, query resolution, and site documentation.
CLIN-Vision
Central monitoring service providing remote data surveillance, risk-based monitoring, query oversight, and site performance analysis.
CLIN-360°
Flexible operational support across clinical trial lifecycle including regulatory submissions, project management, site management, and data management.
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.