Biorasi
Mid-size, full-service contract research organization (CRO) with 20+ years of experience delivering global clinical trials. Offers integrated clinical operations, data sciences, safety/pharmacovigilance, regulatory support, quality systems, and study rescue capabilities across multiple therapeutic areas and 48 countries, with sponsor-facing real‑time dashboards.
Industries
Nr. of Employees
large (251-1000)
Biorasi
Products
TALOS®
A clinical trial technology and program management platform that integrates with most databases to gather lab results, outcomes data, assessment results, and other data in one place.
TALOS™ dashboard
Biorasi's proprietary dashboard that incorporates machine learning and data analytics features for continuous monitoring of clinical trials.
IBM Clinical Development (ICD) platform
A single-instance, fully-integrated, SaaS clinical data management system (CDMS) designed to help reduce the cycle time to start, amend, and manage clinical studies, enabling clinical trial sponsors and site staff to reduce time and cost by centralizing and organizing information with 24/7 access via any web-enabled device.
IBM Clinical Development (ICD) CDMS Platform
IBM Clinical Development is a single, fully-integrated, SaaS Clinical Data Management System designed to help reduce the cycle time to start, amend, and manage clinical studies, enabling life sciences organizations to deliver therapies and innovations faster to their patients.
Rescue and Recovery
Biorasi's clinical trial rescue service that helps get trials back on track and across the finish line by delivering custom strategies, better outcomes, and renewed stakeholder trust.
AI-Powered Feasibility
Biorasi's AI-Powered Feasibility combines dynamic site modeling, feasibility outreach, and real-time enrollment forecasting to provide sponsors with a data-verified foundation for trial success.
TALOS®
A clinical trial technology and program management platform that integrates with most databases to gather lab results, outcomes data, assessment results, and other data in one place.
TALOS™ dashboard
Biorasi's proprietary dashboard that incorporates machine learning and data analytics features for continuous monitoring of clinical trials.
IBM Clinical Development (ICD) platform
A single-instance, fully-integrated, SaaS clinical data management system (CDMS) designed to help reduce the cycle time to start, amend, and manage clinical studies, enabling clinical trial sponsors and site staff to reduce time and cost by centralizing and organizing information with 24/7 access via any web-enabled device.
IBM Clinical Development (ICD) CDMS Platform
IBM Clinical Development is a single, fully-integrated, SaaS Clinical Data Management System designed to help reduce the cycle time to start, amend, and manage clinical studies, enabling life sciences organizations to deliver therapies and innovations faster to their patients.
Rescue and Recovery
Biorasi's clinical trial rescue service that helps get trials back on track and across the finish line by delivering custom strategies, better outcomes, and renewed stakeholder trust.
AI-Powered Feasibility
Biorasi's AI-Powered Feasibility combines dynamic site modeling, feasibility outreach, and real-time enrollment forecasting to provide sponsors with a data-verified foundation for trial success.
Services
Site selection, initiation, on-site and remote monitoring, and tailored monitoring strategies including RBM and central monitoring.
End-to-end data management, biostatistics, and statistical programming with CDISC submission packages and real-time reporting.
Global PV operations including AE/SAE case processing, signal detection, safety database management, and regulatory reporting.
QMS development, audits, CSV and SaMD validation, vendor qualification, and training to maintain inspection readiness.
AI-driven feasibility, automated feasibility form population, dynamic site readiness modeling, and enrollment forecasting.
Turnkey transition and remediation of struggling programs, including regulatory handoff, re-engagement of sites, and operational corrective plans.
Site selection, initiation, on-site and remote monitoring, and tailored monitoring strategies including RBM and central monitoring.
End-to-end data management, biostatistics, and statistical programming with CDISC submission packages and real-time reporting.
Global PV operations including AE/SAE case processing, signal detection, safety database management, and regulatory reporting.
QMS development, audits, CSV and SaMD validation, vendor qualification, and training to maintain inspection readiness.
AI-driven feasibility, automated feasibility form population, dynamic site readiness modeling, and enrollment forecasting.
Turnkey transition and remediation of struggling programs, including regulatory handoff, re-engagement of sites, and operational corrective plans.
Expertise Areas
- Clinical trial management
- Study rescue and recovery
- Data sciences and biometrics
- Pharmacovigilance and safety surveillance
Key Technologies
- Electronic data capture (EDC) / eCRF
- Clinical trial management system (CTMS) and sponsor dashboards
- CDISC standards (SDTM, ADaM)
- Statistical programming and TLF generation
News & Updates
Article discussing regulatory environment changes at FDA, escalation pathways, real-world evidence considerations, and tactical advice for sponsors.
Company-supported programs leading to five FDA approvals across multiple therapeutic areas including neurology and rare disease (examples listed on site).
Reported recovery of over $150M in struggling clinical programs through rescue and recovery engagements.
Article discussing regulatory environment changes at FDA, escalation pathways, real-world evidence considerations, and tactical advice for sponsors.
Company-supported programs leading to five FDA approvals across multiple therapeutic areas including neurology and rare disease (examples listed on site).
Reported recovery of over $150M in struggling clinical programs through rescue and recovery engagements.