|
Clinfinity offers the complete range of clinical biostatistics and statistical programming services. Experienced programmers work in unison with the biostatisticians to fully support the requirements of any project. This collaborative effort is facilitated using robust and efficient processes resulting in consistent standards and quality. Team members dedicated to each project are highly-educated and experienced professionals with a keen attention to detail and a commitment to excellence. Clinfinity offers the following comprehensive services:
Biostatistics A study's foundation begins with a well-developed plan. Clinfinity works closely with the project sponsor to create a statistical analysis plan based on an established protocol. Our focus is to ensure the protocol, statistical analysis plan, and case report forms are precise and consistent. We are passionate about exceeding the client's expectations in providing each of the following:
- Protocol review, statistical power and sample size calculations, and study population definitions
- Design clear and concise Case Report Forms (CRFs) or thoroughly review existing CRFs
- Statistical Analysis Plans and Analysis Dataset Specifications
- Annotated Tables, Listings, and Figures shells
- Senior statistical review of all deliverables
Programming Clinfinity's programmers work in conjunction with the biostatisticians to ensure the production of a fully validated, quality product adhering to FDA guidelines and ICH standards. We are dedicated to meeting study timelines with accurate, dependable results. Analysis datasets and data displays are double independently programmed, and all deliverables undergo a thorough senior level statistical review. Our programming services include:
- Generation of Tables, Listings, and Figures in support of individual clinical trials or for Integrated Summary of Efficacy/Safety (ISE/ISS) packages
- Analysis Datasets creation
- CDISC (SDTM,ADaM) implementation
- Patient profiles
- Ad hoc analysis
|