Novella
IQVIA Biotech is dedicated to supporting biotech companies from innovation to impact through full-service clinical development with specialized, dedicated teams. They focus on simplifying the journey to successful drug development by providing therapeutic expertise, strategic problem-solving, and flexible, patient-centric solutions to help bring life-saving therapeutics to market efficiently and cost-effectively.
Industries
Nr. of Employees
large (251-1000)
Novella
Morrisville, North Carolina, United States, North America
Services
Full-service clinical development (end-to-end CRO services)
Integrated clinical development services from protocol design through regulatory submission and commercialization support, delivered by dedicated therapeutic teams.
Decentralized trial platform and digital tools
Provision and integration of eConsent, eCOA/ePRO, patient portals, and device connectivity to enable decentralized or hybrid study designs and patient-centric data collection.
Biomarker and central laboratory services
Lab-based biomarker testing and assay development using high-sensitivity platforms to support CNS and other therapeutic-area studies, with guidance on biomarker selection and regulatory considerations.
Regulatory submission and CTR/CTIS support
Regulatory planning, submission preparation, CTIS/CTR transition support, and training to meet evolving regional regulatory requirements.
Project management and clinical operations
Global program management, operational oversight, risk management, and coordination across functional teams to deliver clinical programs on time and on budget.
Full-service clinical development (end-to-end CRO services)
Integrated clinical development services from protocol design through regulatory submission and commercialization support, delivered by dedicated therapeutic teams.
Decentralized trial platform and digital tools
Provision and integration of eConsent, eCOA/ePRO, patient portals, and device connectivity to enable decentralized or hybrid study designs and patient-centric data collection.
Biomarker and central laboratory services
Lab-based biomarker testing and assay development using high-sensitivity platforms to support CNS and other therapeutic-area studies, with guidance on biomarker selection and regulatory considerations.
Regulatory submission and CTR/CTIS support
Regulatory planning, submission preparation, CTIS/CTR transition support, and training to meet evolving regional regulatory requirements.
Project management and clinical operations
Global program management, operational oversight, risk management, and coordination across functional teams to deliver clinical programs on time and on budget.
Expertise Areas
- Clinical trial management
- Oncology clinical development
- Cell and gene therapy development
- Central nervous system (CNS) trials
Key Technologies
- Electronic clinical outcome assessments (eCOA/ePRO)
- Electronic consent (eConsent)
- Connected devices and wearables (remote biometric monitoring)
- Telemedicine and remote visit platforms