Biostatistics

Biostatistics and data reporting have been the pillars of BioClever’s business as a Contract Clinical Research Services provider since 2005.

At BioClever CRO, we perform data statistical analyses according to international standards and traceability, based on the reference SAS® statistical package.

All our studies are conducted according to standard operating procedures that comply with the ICH guidelines E9 (Statistical Principles for Clinical Trials) and E3 (Structure and Content of Clinical Study Reports), from protocol writing, statistical analytical planning (randomization, sample size calculation, etc.), statistical programming (reports and statistical analyses), to providing statistical consultancy services to the medical community.

We perform:

• Study design and protocol review
• Sample size and power calculations
• Randomization schemes and IWRS services
• Statistical analysis plan
• Adaptive trial design
• Biostatistics consulting services
• Feasibility studies
• CDISC (SDTM and ADaM)
• Data Safety Monitoring Board (DSMB) support
• Interim analyses
• Statistic analyses/TLF production 
• Independent/unblinded analyses and support
• CSR input
• Patient profiles
• Data conversion and integration
• Submission strategy, planning, and analyses
• Expert testimony, regulatory support/meetings
• Ad hoc and conference support
• Post-marketing manuscript support
• Pharmacoeconomics
• Competitive analysis
• Late phase solutions