Biostatistics
Unlocking the Power of Data through Precision Biostatistics.
We believe that the key to a successful clinical trial is a sound biostatistics plan that takes into account all the important aspects of the study. We understand the importance of timely, accurate, and reliable data analysis and reporting, and we strive to meet those needs.
We understand the importance of timely, accurate, and reliable data analysis and reporting, and we strive to meet those needs. At YOUV, we are committed to providing our clients with reliable and high-quality biostatistics services that support the success of their clinical trials.
Services We Offer.
Complete end-to-end Statistical Solutions to meet your Clinical trial needs.
- Preparation of Statistical analysis plans for traditional as well as adaptive clinical trials
- Randomization, Power calculation with defined sample size and Interim analysis
- Expert personnel to serve as statisticians for Data Monitoring Committees
- Designing and development of tables, graphs and listings
- Recommendation / evaluations on study design and regulatory submissions
- Interim analysis support for adaptive clinical trials
- Analysis datasets and integrated database in CDISC format thereby fulfilling electronic submission requirements
- Study Analysis and Reporting
- Analysis datasets specifcations development
- Creation of derived datasets
- Creation of tables, listings and figures (TFL)
- QA/QC/validation of datasets and TFL
- PK/PD parameter calculation
- Creation of ISS (SCS) / ISE (SCE) analysis databases
- Observational study analyses
- Data mapping
- CDISC services (SDTM, ADaM and Define.XML)
- Post-marketing data analyses and reporting
- eCTD submission support
- Patient profile listings and figures
- Patient summaries for narratives
- Regulatory queries support
Biostatistics Services in Nutshell:
Our biostatistics team is committed to providing comprehensive support from the outset of your clinical research study. By working closely with you in the study design phase, we ensure that all necessary considerations for data collection and analysis have been taken into account.
- Determine the most effective data collection points
- Develop a statistical analysis plan.
- Ensure proper data management planning.
- Provide sample size calculation and power analysis support.
- Review and provide feedback on study protocols and Case Report Forms
- Collaborate with study team to ensure appropriate statistical methods are being used
Our biostatistics team is committed to providing the highest level of support during the conduct of your clinical research study. We work closely with you to ensure that the study is progressing smoothly and efficiently, and that all data is accurate and of high quality.
- Ongoing support for data collection, management, and quality control
- Interim analysis support (if needed)
- Monitoring of study data to ensure quality and accuracy.
- Assistance with adverse event reporting and statistical analysis
- Support with protocol amendments and deviation management
Our biostatistics team is committed to providing comprehensive support throughout the entire clinical research process. By delivering high-quality final study reports and assisting with publication and regulatory submissions, we ensure that your study results are communicated effectively and efficiently.
- Perform statistical analysis.
- Prepare comprehensive final study report.
- Support with publication and presentation of results (if required)
- Provide data analysis and interpretation support.
- Assist with regulatory submissions and interactions with regulatory agencies.
- Provide ongoing archiving and maintenance of study data
Case Studies.
Adding value to your businesses through our services
Other Expertise.
Clinical Data Management
Pharmacovigilance
Medical Writing
