Pre-Clinical & Early Phase Clinical Development Solutions in the Heart of BioBeach
Biometrics
Biometrics is the cornerstone of data integrity and statistical rigor in clinical development. The collection, analysis, and interpretation of every piece of data must be accurate, reliable, and statistically sound to meet stringent regulatory standards and pave the way to commercialization.
Whether it’s biostatistics, data management, statistical programming, bioinformatics, computational biology, machine learning engineering, record keeping, compliance, or vendor selection and oversight, our professionals bring their years of experience to provide you comprehensive support and drive your pipeline forward.
Data Management/Clinical Data Management (CDM)
CDM System Implementation
Electronic Data Capture (EDC)
Data Collection Design & Entry
Data Validation & Cleaning
Data Monitoring
Vendor Oversight
Biostatistics
Protocol Development & Review
Curating Statistical Analysis Plans (SAPs)
Data Analysis & Interpretation of Results
Developing Clinical Study Reports (CSRs)
Safety Monitoring Review Meetings
Development & Review of SMR Charters
Adverse Event Analysis
Statistical Programming
Data Preparation
Generation of Tables, Listing, & Figures (TLFs) & Repeat Tables
Validation of TLFs & Repeat Tables
Data Visualization
Data Analysis & Correlation
Clinical Bioinformatics & Bioinformatics
Genomic Data Analysis
Biological Data Integration
Biomarker Identification
Patient Data Analysis
Pharmacogenomics & Personalized Medicine
Clinical Pharmacology
Study Design & Protocol Development
Pharmacokinetic (PK) Analysis
Pharmacodynamic (PD) Analysis
Drug-Drug Interactions (DDIs) Analysis
Adverse Event Analysis
Modeling and Simulation
Collaboration on Regulation Submissions
Clinical Trial Monitoring
San Diego, CA info@Totellinc.com
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