Statistical analysis and reporting

Services for Clinical Trials

• Study design, sample size estimations and power calculations
• Database design, data entry and validation
• Data warehousing for clinical trials
• Medical writing
• Clinical trials information systems

Related services

• Toxicity and safety models
• Regulatory guidance and consulting
• Biomarker discovery and validation
• Pre-clinical pharmacokinetics
• In vivo disease models

Company statistician services

We provide our customers with experienced pharma professionals to support you in statistics. We act in senior roles to plan activities, to supervise other service providers and to communicate with your partners and regulatory authorities. We promote the use of statistical methods from drug discovery to phase IV studies, marketing and production.

Operative statistics

We provide our customers with statistics of single studies, including:

• Study planning and protocol writing
• Sample size calculations
• Randomisation
• Statistical programming
• Statistical analyses
• Report writing
• Interpretation of the results
• Writing of statistical report, study report and publications
• Statistical contribution to data and safety monitoring board
• Interim and meta analyses
• Statistical contribution to regulatory meetings
• Integrated summary of safety and efficacy (CTD, NDA)
• Deployment of novel statistical methodology

Training

We provide our customers tailored training in statistics from basics to advanced statistical methods.
All our studies are tailored on customer’s request. For more information, contact us from this link.