Pre-Clinical & Early Phase Clinical Development Solutions in the Heart of BioBeach
Clinical Strategy & Development
Your strategic approach to the clinical stage of development is pivotal in transforming a promising drug candidate into a market-ready therapy. This function involves putting together the regulatory submissions needed to begin trials, designing and executing clinical trials that provide robust data on the safety, efficacy, and optimal usage of your product, manufacturing and developing your product, vendor selection and oversight, and more.
Our professionals serve as an in-house extension of your internal team to craft tailored clinical development plans that align with regulatory expectations and market needs, ensuring your trials are efficient, cost-effective, and poised for success.
San Diego, CA info@Totellinc.com
Regulatory Affairs & Technical & Medical Writing
Regulatory Strategy
Submission Preparation
Technical & Medical Writing
Formatting
eCTD Publishing
Document Changes & Maintenance
Government Agency & Health Authority Representation
**see Regulatory Affairs in Clinical Trials Section for more information
CMC
Process Development
Analytical Development
Drug Formulation Development
Quality Contol (QC) & Quality Assurance (QA)
Supply Chain Management
Technology Transfer
Risk Management
CDMO Selection & Oversight
Lifecycle Management
Optimization
Scale-Up
**see CMC in Clinical Trials section for more information
Clinical Operations
Clinical Strategy
Trial Design
Protocol Development
Statistical Design
Trial Execution
Project Management & Monitoring
Compliance Monitoring
CRO Oversight
**see Clinical Operations in Clinical Trials section for more information
Medical Oversight
Protocol Development and Review
Investigator Training and Support
Safety Monitoring
Informed Consent
Medical Review
Clinical Assessment
Patient Recruitment and Retention Strategies
Exclusion & Inclusion Criteria
Data Review & Compliance
Regulatory Compliance
*see Medical Affairs in Clinical Trials section for more information
Biometrics
Clinical Pharmacology
PK/PD
Bioinformatics
Data analysis
Computational biology
Biostatistics
Protocol Review
SMR Charter
Safety Monitor Meetings
Clinical Bioinformatics
Machine Learning Engineering
Statistical Programming
Generation of Shell Tables, Listings, and Figures
Generation of Repeat Tables
Quality Check
**see Biometerics in Clinical Trials section for more information
Quality Contol (QC) & Quality Assurance (QA)
Compliance
GxP Auditing
Inspection Readiness
**see QC & QA in Clinical Trials section for more information
CRO/Vendor Selection & Oversight
Selection & Qualification
Auditing
Data Management (DM)/Clinical Data Management (CDM)
**see CRO/ Vendor Oversight in Clinical Trials section for more information
Related Topics
