Competencies Consulting Services
Biometrics
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Quick delivery of reliable, high-quality data is essential to make the right decisions at the right moment in the trial.
Our data science experts and state-of-the-art technologies will support you with insightful solutions in all aspects of handling and analysis of clinical study from database design and set-up through data collation to its reporting across all phases of your study.
All that we do is being strongly focused on delivery of study results on-time, on budget, in line with your needs and expectations, utilizing an integrated solution proprietary of Accelsiors combining purposeful databases supported by expertise in statistical design, analysis and reporting and proactive operational leadership.
Our team of experts in Data management, Biostatistics, Clinical programming and Medical writing will support you with flexible solutions and our integrated clinical trials technologies across all phases of your development program from the planning of data management through the proper data recording to the moment when it’s reported.
We provide a full-service data and analytics solution for an on-time, on budget study execution:
- Study design (including adaptive study designs) / protocol development with medical / scientific consultation
- Custom method development
- Sample size and power calculations
- Simulation studies
- PK / PD modelling
- Drug interaction evaluations
- Randomization schemes
- Statistical Analysis Plan (SAP)
- Clinical and statistical programming
- Designing statistical tables, data listings and figures for clinical study reports
- Regulatory guidance, planning, and meeting representation
- Integrated summary of safety and efficacy analyses (ISS/ISE)
- Data Monitoring Committee services
- CDISC-compliant datasets
- Assessment of Bioequivalence/Bioavailability
Let us accelerate your clinical drug development program!
Are you interested in learning more about how Accelsiors can create solutions to help you accelerate your clinical trials? Our team is ready to answer your questions. Get in touch with our experienced drug development experts!
