Veristat

Veristat turns clinical development data into operational and regulatory decisions through biostatistics, data management, clinical execution, and regulatory support. Its homepage cites 105+ regulatory approvals, and its services span trial delivery, safety, quality, market access, and evidence generation.

Biometrics and Clinical Data

• Sponsors can plan analyses and produce statistical outputs through biostatistics services covering study design, protocol development, analysis, regulatory submissions, statistical analysis plans, and tables, listings, and figures. InStat is a statistical analysis product that supports submission-ready TLF production with validated statistical engines and biostatistician oversight.
• Teams can manage clinical data from protocol review and CRF design through database build, data review, query management, database lock, and archival. Veristat also develops programmed edit checks, SDTM and ADaM datasets, and Define.xml documentation in line with applicable standards and controlled terminology.

Clinical Development and Regulatory Delivery

• Sponsors can run complex Phase I–III clinical development programs with clinical trial project management, study start-up and site activation, site contracting and budget negotiations, monitoring, medical monitoring, data monitoring committees, TMF oversight, and decentralized or hybrid trial support.
• Regulatory teams can set development strategy and engage agencies using cross-functional planning, regulatory intelligence, IND and CTA support, marketing application support, regulatory writing, CMC planning, eCTD publishing, and clinical trial disclosure services. CoAuthor, its technology-enabled patient narrative writing, works from SDTM and ADaM datasets to deliver consistent narratives at scale. In the UK, EU and Switzerland, Veristat can act as MAA applicant and MA holder until a client has a local entity or partner. It also supports device and IVD regulatory affairs, including clinical evaluation documentation and EU MDR and IVDR compliance.

Safety, Quality, and Evidence Operations

• Drug safety teams can collect and process safety information, review source documentation for reportability and completeness, perform ICSR case processing, submit SUSARs, conduct literature surveillance, and prepare aggregate reports and benefit-risk assessments. Its medical information teams answer patient and HCP questions and collect adverse event reports.
• Quality teams can prepare for regulatory inspections, conduct GMP, GDP, and GVP audits, manage CAPA, deviations, change control, SOPs, complaints, and QMS work, and provide QP services and batch certification. Market access teams can conduct payer and HCP research, run advisory boards, develop HTA and reimbursement dossiers, and plan pricing and reimbursement strategies.

Best Fit

• Best suited to pharmaceutical, biotechnology, and medical-device sponsors seeking CRO delivery across complex clinical development, biometrics, regulatory submissions, pharmacovigilance, and quality activities.
• Also fits organizations needing contract staffing and talent augmentation, natural-history or observational study operations, external control groups, dose-selection planning, or quality audits for M&A, in-licensing and partnership due diligence.