Celerius Clinical Research is a contract research organization (CRO) that provides comprehensive clinical trial services to pharmaceutical and biotechnology companies. They manage all phases of clinical research, from study design and patient recruitment to data management and regulatory submissions, helping clients bring new therapies to market efficiently.
Funding
Funding not disclosed
Founders
Product
Problem
Pharmaceutical and biotechnology companies face challenges in efficiently conducting clinical trials, including complexities in study design, patient recruitment, data management, and regulatory compliance, which can delay the time it takes to bring new therapies to market. Managing these trials requires expertise across multiple domains and adherence to stringent regulatory guidelines.
Solution
Celerius Clinical Research is a contract research organization (CRO) that offers comprehensive clinical trial management services to pharmaceutical and biotechnology companies, streamlining the process of bringing new therapies to market. They provide support throughout the entire clinical trial lifecycle, from initial study design and protocol development to clinical data management, biostatistics, and regulatory submissions. Celerius leverages technology and experienced project management professionals to ensure trials are conducted efficiently, within budget, and in compliance with Good Clinical Practice (GCP) guidelines and regulatory requirements. Their services also include pharmacovigilance, laboratory services, and site selection from their network of wholly-owned sites.
Target Audience
Celerius Clinical Research primarily serves pharmaceutical and biotechnology companies seeking to outsource clinical trial management, as well as sponsors and other CROs looking for specialized expertise and access to clinical trial sites.
Features
- Clinical operations and study monitoring, including protocol design, site management, and study closeout
- Clinical data management, including database setup, data validation, and quality management
- Biostatistics and SAS/R programming for data analysis
- Medical writing and review for regulatory submissions
- Pharmacovigilance services for patient safety monitoring and adverse event reporting
- Regulatory affairs support with expertise in FDA, EMA, and international regulatory requirements
- Bioanalytical services with CLIA/CAP certified laboratory, including method development & validation, PK/PD analysis and biomarker analysis
- Access to wholly-owned clinical trial sites with diverse patient pools