Clinart has an extensive experience to develop a statistically rigorous and customized plan for each project. Working as your partner, Clinart’s expert biostatisticians work closely with clients to determine the ideal methods for collecting, analyzing and presenting data, all in compliance with regulatory guidelines.
- Consultation or strategic advice
- Study randomization
- Sample size calculation, justification
- Statistical coordination of SAP implementation
- Develop Statistical Analysis Plan
- Interim Analysis, Analysis Datasets, TLFs
- Design mock data displays
- Program derived datasets and TFLs
- Perform statistical analysis, and produce SDTM, ADaM, TLFs
- Analysis of statistical issues (e.g., interaction effects, assumptions, exploratory analysis)
- Documentation of databases
Medical writing is an established core function at Clinart. The medical writing team is fully integrated with the medical monitoring, pharmacovigilance, and biostatistics teams.
Medical Writing Services
- Protocol design and development.
- Clinical Study Report & Manuscripts
- Produce prototype informed consent.
- Prepare skeleton report and write patient narratives.
- Customized Writing (i.e. Training Manuals, IB, PIL/ SmPC) including rewriting service, substantive editing and proofreading.
- Poster design and creation.
- Slide deck design and creation.
- Journal selection, publication feasibility, journal submission and publication management
- Full scope Advisory Board Meetings management and report generations.
- Full scope Delphi Panel management.