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Veristat
About CRO
Veristat is a global clinical research organization and consultancy supporting complex drug, biologic, and medical device development programs. The company partners with emerging, small, and mid-sized biopharmaceutical organizations across the clinical development, regulatory registration, and commercialization lifecycle.
Veristat combines scientific consulting, clinical operations, biometrics, medical writing, regulatory affairs, and safety expertise within flexible full-service, functional service, and strategic resourcing models. Its teams have particular experience navigating scientifically challenging programs, complex indications, and regulatory pathways where integrated planning and execution are critical.
Technology & Expertise
Veristat applies regulatory, clinical, statistical, and operational expertise to help sponsors design development strategies, execute clinical studies, analyze trial data, and prepare submission-ready documentation. Key areas of expertise include: Complex and adaptive clinical trial design Biostatistics and statistical programming Clinical data management and standards implementation Regulatory strategy and agency interactions Regulatory and clinical medical writing Clinical operations and site management Medical monitoring and patient safety Pharmacovigilance and post-marketing surveillance Quality management and inspection readiness Drug, biologic, cell and gene therapy, and medical device development Veristat’s technology capabilities include InStat™, an automated biostatistics platform designed to produce submission-ready tables, listings, and figures using validated statistical engines and expert biostatistician review. The company also uses electronic quality-management infrastructure to support controlled documentation, training management, compliance reporting, and audit trails.
Core Services
Clinical Development Consulting Development planning, protocol strategy, study design, statistical power assessment, adaptive designs, and program-level decision support. Full-Service Clinical Trials Integrated support for clinical trial planning, project management, monitoring, site management, patient recruitment, retention, and decentralized trial activities. Biometrics Biostatistics, clinical data management, statistical programming, data monitoring committees, CDISC and regulatory standards implementation, analysis, and regulatory reporting. Regulatory Affairs Global regulatory strategy, regulatory consulting, agency meeting support, marketing applications, regulatory approvals, CMC support, publishing, and submission management. Medical Writing Protocols, clinical study reports, investigator brochures, regulatory briefing documents, safety narratives, agency communications, disclosure documents, and marketing applications. Medical Affairs and Patient Safety Medical monitoring, safety oversight, data monitoring committees, risk management, and clinical trial safety services. Pharmacovigilance Pre-approval and post-marketing safety surveillance, case processing, aggregate reporting, signal management, and safety-system support. Quality Assurance and Compliance Quality-management-system development, SOP creation, audit programs, vendor qualification, inspection readiness, CAPA management, computer-system validation, and European regulatory representation. Functional Service and Resourcing Flexible access to clinical, regulatory, statistical, medical-writing, safety, and operational specialists through functional service provider and strategic resourcing models.
Accreditations & Compliance
Veristat operates within global GxP and data-protection frameworks applicable to clinical research and regulated product development. Its quality and compliance programs support requirements and expectations from agencies including the FDA, EMA, Health Canada, and Swissmedic. Compliance capabilities include: Good Clinical Practice, including ICH E6 and applicable FDA and European requirements Good Manufacturing Practice support Good Distribution Practice and supply-chain quality oversight GDPR, HIPAA, and global data-protection compliance ALCOA data-integrity and documentation principles Validated systems and electronic audit trails Quality-management-system and SOP development Regulatory inspection preparation and support Vendor qualification, internal audits, CAPA, and change control Regulatory submission publishing and validation Veristat also reports maintaining Swissmedic-licensed pharmaceutical entities and establishment licenses supporting pharmaceutical and advanced therapy medicinal product activities in Switzerland. Its quality infrastructure includes the MasterControl electronic quality-management platform for controlled documentation, electronic training, compliance reporting, and audit-trail management. Specific certifications, licenses, and inspection records should be confirmed directly with Veristat when required for vendor qualification or procurement.
