We manage all aspects of your data—from study startup to submission and closely collaborate with Data Management and Clinical teams to ensure that the timelines and milestones of the trial are met.
Well-designed clinical trials are essential to successful clinical development. Many compounds do not reach market because of flaws in the design stage. To optimize your study, you need a partner who will help you plan the course of your clinical trial, proactively improve predictability, reduce risks and help you reach Go/No-Go decisions faster. Our experienced biostatistician will partner with you to provide the optimal clinical trial design, looking for efficacy signals to achieve better outcomes for the resources spent. This includes developing the synopsis and the full protocol document, calculating the sample size for conventional, group-sequential or adaptive designs (including Bayesian designs), running trial simulations, and proposing innovative solutions to expedite and optimize chances of success of your clinical trial.
Study Design Services include:
Selection of the patient population;
- Choice of efficient and reliable endpoints, as well as validation of surrogate endpoints
- Sample size calculation
- Sample size re-assessment during the study (blinded or unblinded using DMC)
- Trial simulations
- Adaptive trial set-up
- Factorial and cross-over designs for selected situations
- Statistical analysis using of state-of-the-art and novel methods
- Interim analysis
- Experience in assisting clients in dealing with regulatory authorities, including the FDA and EMA, to discuss the study design or to defend the study results
Biostatistics-Driven IRT/IWRS: Unbiased Assessment of Outcomes in Clinical Trials
We will provide the most appropriate randomization methodology to meet your trial’s specific needs – this could be dynamic randomization (minimization), preplanned schedule (balanced or unbalanced), stratified randomization according to prognostic factors, multi-stage or any other method to help customize your study goals. The IRT/IWRS is fully integrated with our EDC system, and is adjustable throughout the clinical trial with no downtime.
Comprehensive Data Monitoring Committee Services
A DMC—Data Monitoring committee or DSMB—Data Safety Monitoring Board, is an independent panel of experts who periodically review clinical trial data to ensure integrity, scientific rigor and patient safety in clinical studies. To support this critical function, Bioforum provides comprehensive Data Monitoring Committee services designed for pharmaceutical and biotech companies.
- Data Monitoring Committee expertise:
- Provide an independent blinded/un-blinded statistician
- Charter design or review
- Safety and interim efficacy analyses
- Design of output templates
- Data transfer from all parties: Sponsor, CROs, central laboratory, etc.
- Data quality review
- Blinded or unblinded analyses
- Produce and distribute tables, figures and listings for interim analyses
- Writing of blinded/unblinded reports
- Secure Data Sharing:
- A secure data sync and sharing service with flexible storage options and access rights
- Encrypts data over the web integrating stringent security requirements
Find out more about Our Expertise.