Biostatistics and Data Analysis
Advanced analytics directly drive smart decision-making
Data is key to product development, clinical trials and regulatory submissions in the life sciences industry. BioBoston Consulting Biostatistics and Data Analysis services empower life sciences companies with advanced statistical expert support enabling you to make balanced, data-informed decisions that are reliable, compliant, and transformative for your business.
Why BioBoston Consulting for Biostats and Data Analysis?
Besides subject matter knowledge in life science data
Our experienced team of biostatisticians specializes in understanding and analyzing complex datasets from pharmaceutical, biotech, and medical device studies. We know clinical data and preclinical research, we understand product development — and we provide expertise in transforming your readouts into insights.
Full-Service Data Analysis Solution
Tailored level of service: We are there with you from study design to final analysis, so that your data is analysed appropriately, and in line with regulatory requirements. We will work hand-in-hand with you to create tailored statistical models for your specific study or development project.
Compliance and Reporting
Our biostatistics team certifies full compliance with US FDA, EMA and ICH guidelines for all data analysis and reporting Our services in this space enable to you achieve robust outcomes that conform to the regulators expectations and arm yourselves for regulatory submissions.
Tailor-Made Statistical Solutions
Our biostatistical services are customized and personalized to cater for your needs, from early-stage research to opportunities to conduct clinical trials and prepare Market Approval. Our solutions are created with the end in mind of reducing study design bottlenecks, lowering risks and increasing data value.
Data-Driven Decision Making
We will enable life sciences companies to make educated data-driven decisions through accurate, trusted and on-time analysis. With a wealth of experience in data management, statistical modeling and interpretation, we provide you with the information that informs your product development and regulatory strategy.
Biostatistics and Data Analysis Services Provided By Us
- Research Design and Statistical Consultation
- Data Management and Cleaning
- Statistical analysis and model building
- Clinical Trial Data Analysis
- Regulatory Submission Support
- Real-World Data Analysis and Post-Marketing
- Leverage your Data with BioBoston Consulting
Contact Us Today
Contact us to discuss your biostatistics and data analysis requirements and how BioBoston Consulting can help.
All Services
- Quality Assurance and Regulatory Compliance
- Investigational New Drug (IND) Application
- Regulatory Strategy & Submissions
- Investigational Device Exemption (IDE) Application
- Vendor Selection & Qualification
- Project & Risk Management
- Technology Transfer
- Quality Management Systems (QMS)
- Gap Assessment and Remediation
- Funding and Investment Strategies
- Research and Development (R&D)
- Biostatistics and Data Analysis
- Lab Operations and Efficiency
- Medical Writing
- CDMO Vendor Selection Qualification & Oversight
- CRO Selection & Qualification
- CTO Selection & Qualification
- Data Integrity and Software Implementation
- Clinical Operations
- Clinical Trial Monitoring
- FDA Inspection Readiness
- Internal and Supplier Audits
- Regulatory CMC Support
- Qualification and Validation
- GxP Training
- Computer System Validation (CSV)
- Strategic Advising
- Process Optimization
- Health Authority Meeting Support
- Recruitment