What We Do
Hard work and effective communication lead to a great working relationship
Based on our experience, a quality product delivered on time and on budget is a necessity for our clients. We also strongly believe that relationship building, problem-solving, flexibility and highly qualified team members are the basis for repeat business. Clinfinity uses a lean management process to guarantee a high level of communication with our clients. Our project managers are also full team members, allowing us to ensure our projects are completed on time and on budget. Our top priority is to minimize the amount of re-work and reduce the number of review cycles to streamline the path to approval.
Clinfinity offers a complete range of clinical biostatistics and statistical programming services. Experienced programmers work in unison with 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:
Core Services
Statistical Programming
- 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
Biostatistics
- 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
Medical Writing
- Components of clinical trial clearance applications
- Study protocols
- Investigator brochures
- Clinical and nonclinical summaries
- Annual reports
- Full, abbreviated, and synoptic clinical study reports
- Subject medical narratives
- Clinical and nonclinical summary and overview components of product approval applications
- Regulatory briefing packages and response documents
- Product license renewals (EU)
- Orphan drug applications
- Pediatric investigation plans and waiver requests
- Manuscripts, posters, and abstracts
Regulatory
- Clinical Trial Services
- Regulatory strategy
- Regulatory Submissions
- FDA (and other Health Authorities) Liaison
- Project planning and management
- Labeling
