TriRadial Solutions
TriRadial Solutions is a global life science advisory firm dedicated to helping biopharma and medical device companies navigate scalable growth and bring therapies to patients faster. They focus on improving productivity, partnerships, and compliance through deep domain expertise, innovative solutions, and targeted support in areas such as vendor oversight, inspection readiness, clinical program management, and IT architectures. Their mission is to deliver practical, high-quality People, Process, and Technology solutions to enable clients to build robust, integrated capabilities for scalable growth.
Industries
Nr. of Employees
small (1-50)
TriRadial Solutions
Mahwah, New Jersey, United States, North America
Products
Clinical Readiness Checklist (downloadable)
A checklist resource outlining key factors to assess and maintain clinical and regulatory readiness throughout the life of a trial.
Fact sheets (vendor oversight, QMS, CAPA, inspection and commercial readiness)
Series of downloadable fact sheets summarizing methodologies and frameworks for vendor oversight, quality systems, CAPA, inspection readiness and commercial execution planning.
Clinical Readiness Checklist (downloadable)
A checklist resource outlining key factors to assess and maintain clinical and regulatory readiness throughout the life of a trial.
Fact sheets (vendor oversight, QMS, CAPA, inspection and commercial readiness)
Series of downloadable fact sheets summarizing methodologies and frameworks for vendor oversight, quality systems, CAPA, inspection readiness and commercial execution planning.
Services
Consulting to define sourcing strategy, run competitive RFPs, evaluate vendors, negotiate commercial and MSA terms, and implement governance and performance measurement.
Assess readiness across people, processes, partners and systems; deliver prioritized remediation plans to shorten study start-up and improve operational compliance.
Process mapping, SOP authoring, and right-sized compliance frameworks that balance performance and regulatory requirements for scalable operations.
Inspection readiness assessments, tailored mock inspections, back-room organization and inspector interaction training, plus remediation support.
Define KPIs, connect operational systems, and deliver dynamic dashboards for performance management and inspection-readiness visibility.
Integration planning and execution playbooks to harmonize development, quality, regulatory, and vendor functions across acquired or divested entities.
Consulting to define sourcing strategy, run competitive RFPs, evaluate vendors, negotiate commercial and MSA terms, and implement governance and performance measurement.
Assess readiness across people, processes, partners and systems; deliver prioritized remediation plans to shorten study start-up and improve operational compliance.
Process mapping, SOP authoring, and right-sized compliance frameworks that balance performance and regulatory requirements for scalable operations.
Inspection readiness assessments, tailored mock inspections, back-room organization and inspector interaction training, plus remediation support.
Define KPIs, connect operational systems, and deliver dynamic dashboards for performance management and inspection-readiness visibility.
Integration planning and execution playbooks to harmonize development, quality, regulatory, and vendor functions across acquired or divested entities.
Expertise Areas
- Clinical trial management and execution
- Vendor selection, contracting and lifecycle governance
- Quality management systems (QMS) design and remediation
- Inspection and audit readiness (GCP/GLP/PV)
Key Technologies
- Computer systems assurance (CSA) and validated EDC
- Cloud-based analytics and KPI dashboards
- Master data management (MDM)
- Clinical trial management systems (CTMS) and eConsent
News & Updates
GCP Quality Inspection Readiness Assessment
Assessment for a biotech company preparing for GCP inspection, focusing on quality oversight and compliance with ICH E6 R2.
PV Inspection Readiness Assessment
Evaluation of a biotech company's pharmacovigilance organization ahead of inspection, emphasizing vendor oversight and risk management.
GxP Inspection Readiness Training
Training program for a biopharma company to prepare their team for GxP inspections, including gap assessment and mock inspections.
Clinical Process Transformation
Review and redesign of clinical processes for a biotech company to improve efficiency and compliance.
Clinical Project Management Org and Process
Development of a clinical project management framework for a biotech with multiple assets in development.
Sourcing Strategy
Strategy development for internal vs. outsourced activities in biopharma R&D.
GCP Quality Inspection Readiness Assessment
Assessment for a biotech company preparing for GCP inspection, focusing on quality oversight and compliance with ICH E6 R2.
PV Inspection Readiness Assessment
Evaluation of a biotech company's pharmacovigilance organization ahead of inspection, emphasizing vendor oversight and risk management.
GxP Inspection Readiness Training
Training program for a biopharma company to prepare their team for GxP inspections, including gap assessment and mock inspections.
Clinical Process Transformation
Review and redesign of clinical processes for a biotech company to improve efficiency and compliance.
Clinical Project Management Org and Process
Development of a clinical project management framework for a biotech with multiple assets in development.
Sourcing Strategy
Strategy development for internal vs. outsourced activities in biopharma R&D.