Global Clinical Trials
Full-service contract research organization providing end-to-end support for Phase I–V clinical studies, medical device investigations and post-marketing activities. Services include study start-up, clinical operations, regulatory submissions, safety/pharmacovigilance, data management, quality assurance, medical writing and multi-country operational coordination across the USA, Europe and Asia.
Industries
Nr. of Employees
medium (51-250)
Global Clinical Trials
Headquartered in Princeton, USA; regional office addresses available on country pages
Products
Clinical Trial Management
Management and support services for clinical trials across all phases, including regulatory approval, project management, monitoring, and site administration.
Study Start-up
Services to initiate clinical trials, including site selection, regulatory submissions, and preparation activities to begin study execution.
Scientific and Medical Writing
Preparation of clinical trial documents such as protocols, reports, and regulatory submissions.
Regulatory Affairs
Support for regulatory submissions, compliance, and interactions with health authorities during clinical trials.
Quality Assurance and Quality Control
Oversight and auditing services to ensure clinical trial processes comply with regulatory and quality standards.
Safety Management
Monitoring and management of patient safety data and adverse event reporting during clinical trials.
Clinical Trial Management
Management and support services for clinical trials across all phases, including regulatory approval, project management, monitoring, and site administration.
Study Start-up
Services to initiate clinical trials, including site selection, regulatory submissions, and preparation activities to begin study execution.
Scientific and Medical Writing
Preparation of clinical trial documents such as protocols, reports, and regulatory submissions.
Regulatory Affairs
Support for regulatory submissions, compliance, and interactions with health authorities during clinical trials.
Quality Assurance and Quality Control
Oversight and auditing services to ensure clinical trial processes comply with regulatory and quality standards.
Safety Management
Monitoring and management of patient safety data and adverse event reporting during clinical trials.
Services
Feasibility, site selection, initiation and activation services to achieve study start-up milestones.
Regulatory strategy, dossier preparation and submission support for national and regional authorities.
GCP compliance support, audit readiness and QA/QC activities across clinical studies.
Pharmacovigilance and safety oversight for clinical trials, including SAE processing and reporting workflows.
Clinical data collection, validation and database management services.
Regulatory and scientific document preparation including protocols, reports and clinical overviews.
Feasibility, site selection, initiation and activation services to achieve study start-up milestones.
Regulatory strategy, dossier preparation and submission support for national and regional authorities.
GCP compliance support, audit readiness and QA/QC activities across clinical studies.
Pharmacovigilance and safety oversight for clinical trials, including SAE processing and reporting workflows.
Clinical data collection, validation and database management services.
Regulatory and scientific document preparation including protocols, reports and clinical overviews.
Expertise Areas
- Clinical trial management (Phase I–V)
- Study start-up and site activation
- Regulatory strategy and submissions (national and EU-level)
- Clinical data management and EDC
Key Technologies
- EU Clinical Trials Information System (CTIS)
- National regulatory e-submission portals
- ClinicalTrials.gov and national trial registries
- Investigator and site registry databases
News & Updates
Claims of 20+ years in clinical research, 12 international offices, a global investigator/site database and over 400 completed trials worldwide.
Reported history of passing 90+ audits and maintaining compliance with ICH-GCP, EMA and FDA guidance.
Claims of 20+ years in clinical research, 12 international offices, a global investigator/site database and over 400 completed trials worldwide.
Reported history of passing 90+ audits and maintaining compliance with ICH-GCP, EMA and FDA guidance.