Clinical Study Report (CSR)
It is not enough to be able to collect and group data, you have to be able to identify specifics and analyze the data.
Clinical Study Report
The content of CSR is detailed in the ICH guideline E3. A CSR provides an explanation of the critical design features, methodology, statistical and clinical description, individual patient data, and analysis of the completed study. ADI Intellect follow the guidelines including synoptic, abbreviated and full submission reports, and we make sure that each aspect is covered to the detail.
- Overall study design and description
- Control groups used
- Patient criterion and individual clinical trial patient data
- All aspects of treatment administered including dose and timings, treatment compliance, method of assigning treatment groups and blindings
- Efficacy and safety variables and data collected from the trials
- Data quality assurance and statistical methods used in the protocol and determination of sample size
- Changes in the conduct of the study or planned analysis that occurred during the clinical trials
- Adverse Events and Serious Adverse Events Reporting
- Information presented in tables, graphs, figures, flowcharts, and text in line with regulatory body requirements
Why ADI Intellect
ADI Intellect is a leading medical animation and medical communication company. The team working in the medical animation studio of ADI Intellect honed into animation programming who understand anatomy, biological processes, and medical science. The combination of this medical knowledge and skills in creating 3D computer animation is indispensable to produce an accurate and detailed medical 3D animation.
Whether you want to sell, explain or inspire- we can help.
Let’s Create a Video!
- Research based Approach
- Wide Technology Range
- Audience Centric Content
- Quick Turnaround and Affordable
- 17+ Years in Business
- 600+ Animations
- 4 Step Easy Process