Biostatistics

Our customized clinical data management services, including EDC, Clinical Data Review, Coding, CDISC Conversation & Data Standardization enables complete utilization of the collected clinical data.

The complementary biostatistical services, including SAP Development, SAS Clinical Programming, Analysis, Submission-Ready Services and Statistical Reports are customized and designed specifically to meet the project requirements

Advanced Biostatistics for More Efficient Clinical Trials

Today, a small portion of new compounds succeed to reach the market. There is an increasing need for advanced biostatistics and efficient clinical development strategies to shorten timelines, reduce costs and risks, and improve the quality of submissions. High level advanced statistical methods play a key role in every step of the drug development process.

In Bioforum we believe that the most efficient and cost-effective way to conduct and control clinical trials is to make the best possible use of advanced and innovative statistical methodology.

Various Services in Advanced Biostatistics

  • Study Design
  • Choice of endpoints
  • Statistical Analysis Plan
  • Sample size calculation
  • Trial simulations
  • Statistical Analysis
  • Comprehensive Data Monitoring Committee Services
  • Meta-analysis
  • Representation at meetings with the Regulatory Authorities
  • Integrated summaries of safety and of efficacy
    (ISS,  ISE or PASS, PAES) and statistical sections of NDAs/EU submissions

In working with sponsors:

  • We give special attention to the objectives of the protocol in order to fit the right statistical methodology.
  • We communicate with clinicians to determine the possible outcomes and make sure we optimize your clinical trial by developing the right study design with optimal size and length.
  • We assess the inherent risk in the study design and ensure robustness and consistency of clinical trial results.
  • Help make better data-driven decisions, mitigate risks, and improve the quality and success probability for study submissions by employing advanced methodologies (e.g., Bayesian methods, modelling and simulations, biomarkers validation etc.
  • We ensure high quality throughout all stages of drug development thanks to our experience and profound understanding of ICH GCP, regulatory requirements and ADaM analysis datasets

Our expert biostatisticians offer flexible and innovative solutions for clinical research, and are not afraid to challenge the status quo. With strong science background and in-depth clinical and regulatory experience, our team understands the scientific issues, anticipating and overcoming potential challenges specific to your clinical trial.

1. Study Design

Well-designed clinical trials are essential to a successful clinical development. Many compounds do not get into the market because of flaws in the design stage. To optimize your study, you need a partner who will carefully help you plan the course of your clinical trial, proactively improve predictability, reduce risks, and help you reach Go/No-Go decisions faster. Bioforum biostatistician will partner with you to provide the optimal clinical trial design, looking for efficacy signals and 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.

Clinical Trial Design Services Include:

    • Selection of the patient population;
    • Randomization
    • 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.

2. Randomization

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.

3. 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:
    • Independent statistician
    • Charter design or review
    • Safety and interim efficacy analyses:
    • Design of templates
    • Data transfer from all parties: Sponsor, CROs, central laboratory, etc
    • Data quality review
    • Blinded or unblinded analyses
    • 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