ClinVigilant Clinical Research -Global Clinical Trial Solutions Provider
Clinvigilant Research is dedicated to providing comprehensive clinical trial solutions, including consulting, data management, biostatistics, regulatory compliance, and innovative eClinical platforms. Their mission is to streamline clinical research processes, ensure regulatory compliance, and accelerate the development and market entry of medical products across various industries such as pharmaceuticals, medical devices, nutraceuticals, and cosmetics. With a global reach and a team of experienced experts, Clinvigilant aims to deliver high-quality, efficient, and compliant clinical trial services to help sponsors achieve successful study outcomes and bring new treatments to patients faster.
Industries
Nr. of Employees
small (1-50)
ClinVigilant Clinical Research -Global Clinical Trial Solutions Provider
Dartford, Kent, United Kingdom, Europe
Products
Clinical trial management software (CTMS)
Modular CTMS supporting study planning, site management, participant tracking, document management, budgeting and integrated reporting with EDC and other eClinical systems.
Electronic data capture platform (EDC)
Study design and data capture platform with form builder, workflow scheduling, validation rules, query management, monitoring dashboards and export capabilities.
Electronic consent platform (eConsent)
Digital informed consent system supporting multimedia content, comprehension checks, electronic signatures, version control, accessibility and remote consenting.
Electronic Trial Master File (eTMF)
Document repository for trial documentation with access control, versioning, CDISC reference model support, audit trails, search and retrieval, integration with eClinical systems and features to support regulatory submission readiness.
ePRO and eCOA platforms
Patient-facing platforms to collect patient-reported and clinical outcome assessments with reminders, multilingual support, analytics and integration to EDC/CTMS.
eSource platform
Electronic source capture with direct data entry at point-of-care, audit trails, electronic signatures, remote monitoring support and device integration for automatic data ingestion.
Clinical trial management software (CTMS)
Modular CTMS supporting study planning, site management, participant tracking, document management, budgeting and integrated reporting with EDC and other eClinical systems.
Electronic data capture platform (EDC)
Study design and data capture platform with form builder, workflow scheduling, validation rules, query management, monitoring dashboards and export capabilities.
Electronic consent platform (eConsent)
Digital informed consent system supporting multimedia content, comprehension checks, electronic signatures, version control, accessibility and remote consenting.
Electronic Trial Master File (eTMF)
Document repository for trial documentation with access control, versioning, CDISC reference model support, audit trails, search and retrieval, integration with eClinical systems and features to support regulatory submission readiness.
ePRO and eCOA platforms
Patient-facing platforms to collect patient-reported and clinical outcome assessments with reminders, multilingual support, analytics and integration to EDC/CTMS.
eSource platform
Electronic source capture with direct data entry at point-of-care, audit trails, electronic signatures, remote monitoring support and device integration for automatic data ingestion.
Services
End-to-end clinical trial services from protocol design to regulatory submission and post-market surveillance for drugs and medical devices.
eCRF design, EDC implementation, data validation/cleaning, coding and secure database management with regulatory-standard exports.
Protocol statistical review, SAP authoring, statistical programming, TLF generation and regulatory statistical consulting.
On-site and remote monitoring, source data verification, and risk-based monitoring strategies.
Regulatory strategy, eCTD publishing, application authoring, health authority meeting preparation and global submission planning.
Quality management system development, compliance audits, inspection readiness, CAPA and training support.
End-to-end clinical trial services from protocol design to regulatory submission and post-market surveillance for drugs and medical devices.
eCRF design, EDC implementation, data validation/cleaning, coding and secure database management with regulatory-standard exports.
Protocol statistical review, SAP authoring, statistical programming, TLF generation and regulatory statistical consulting.
On-site and remote monitoring, source data verification, and risk-based monitoring strategies.
Regulatory strategy, eCTD publishing, application authoring, health authority meeting preparation and global submission planning.
Quality management system development, compliance audits, inspection readiness, CAPA and training support.
Expertise Areas
- Full-service CRO clinical development
- Clinical trial monitoring and site operations
- Clinical data management and EDC
- Biostatistics and statistical programming
Key Technologies
- Electronic Data Capture (EDC)
- Clinical Trial Management Systems (CTMS)
- Randomization and Trial Supply Management (RTSM)
- Electronic Consent (eConsent)
News & Updates
Clinvigilant supported a randomized clinical trial to validate dietary supplements, ensuring regulatory compliance and efficient data management.
Clinvigilant helped accelerate clinical success for a weight management metabolism booster through strategic trial design and regulatory support.
Clinvigilant enabled global clinical success for a gut health study by supporting regulatory submissions across multiple regions.
Over 100 Successful Regulatory Submissions
Clinvigilant has supported over 100 regulatory submissions worldwide, expediting approvals and market access.
120+ Satisfied Sponsors
Trusted by industry leaders across pharmaceuticals, medical devices, nutraceuticals, and cosmetics.
100% Regulatory Compliance
Ensuring all trials meet international standards, avoiding delays and ensuring data integrity.
Clinvigilant supported a randomized clinical trial to validate dietary supplements, ensuring regulatory compliance and efficient data management.
Clinvigilant helped accelerate clinical success for a weight management metabolism booster through strategic trial design and regulatory support.
Clinvigilant enabled global clinical success for a gut health study by supporting regulatory submissions across multiple regions.
Over 100 Successful Regulatory Submissions
Clinvigilant has supported over 100 regulatory submissions worldwide, expediting approvals and market access.
120+ Satisfied Sponsors
Trusted by industry leaders across pharmaceuticals, medical devices, nutraceuticals, and cosmetics.
100% Regulatory Compliance
Ensuring all trials meet international standards, avoiding delays and ensuring data integrity.