Our Services — celeriuscr

Clinical and Functional Services

Clinical Operations and Study Monitoring

Study Protocol Design
Pre-study planning
Site Management (Site Selection and study initiation)
Study conduct and site monitoring
Study Closeout
Resource Management

Clinical Data Management

• Study Data Management Planning

• Study Database setup (EDC and Manual)

• Data Validation and Quality Management

• Data extraction and Locking

Clinical Biostatistics & SAS/R Programming

Medical Writing & Review

Pharmacovigilance

• The Pharmacovigilance system master file (PSMF) for European agencies
• Patient safety monitoring and AE reporting
• Drug safety and PV
• Life Cycle Safety and Management

Regulatory

Regulatory oversight in clinical trials is crucial to ensure the safety, efficacy, and ethical conduct of studies involving human participants. With over 20+ years of experience with FDA, EMA, European and international regulatory authorities, our Regulatory affairs team helps you proactively plan your regulatory strategy, Streamline your regulatory compliance systems and processes with our end-to-end regulatory services.