Biostatistics Advisory and Consulting Services

High-level advisory and consulting services to optimise your clinical development strategy

Helping our clients to solve unique and complex clinical development challenges

StatisticaMedica provides highly effective, tailored biostatistics advisory and consulting services to help pharmaceutical, biotechnology and medical devices companies to solve unique and complex clinical development challenges.

In the pharmaceutical, biotechnology and medical devices industries, the practices are strict, the standards are extremely high, and there is a necessity to constantly adapt to new needs in the market. These industries require rigorous methods, robust evidence and effective use of resources. StatisticaMedica adapts these industry practices and standards in all the steps of the process.  This approach increases the quality of the outputs and their transferability to patient-oriented results. It helps to advance the development of new therapy protocols and innovation in diagnostics and medical devices.

StatisticaMedica skilfully guides clients through the planning, conduct, analysis and reporting of clinical trials in a range of therapeutic areas including cardiovascular, respiratory, neurology, oncology, dermatology and urology.  Our expert Regulatory Biostatistics Consultants provide high-level strategic advisory and consultancy services that span the entire clinical development process, from innovative study design and protocol writing through to regulatory submission.

Synergistic approach

A key differentiator for StatisticaMedica is our synergistic approach, which combines methodological, regulatory and strategic expertise, to assess and recommend pathways for regulatory approval and successful market access. We assess in parallel the regulatory, methodological, and business requirements of the product to enable us to identify the ‘lean’ pathway, in which the interaction with the regulatory bodies is minimal, the study design is tightly targeted to minimise time and costs, and the evidence gathered is clear and effective for valid claims in the market. 

StatisticaMedica also draws on the expertise of our broad network of medical consultants, who add clinical proficiency and provide patient-oriented advice and facilitate the scale-up of early phase trials. This approach significantly reduces the time and resources required in setting up and implementing a trial, interacting with relevant bodies, and analysing and reporting accurate evidence-based results.

At the cutting edge of the translational research environment

Strategic and effective collaboration with our global network of contacts in academia and research on the most innovative and rigorous statistical methods for data collection, analysis and modelling places StatisticaMedica at the cutting edge of the translational research environment. Our team transfers the knowledge gained from these highly regarded sources to clinical trial programmes and industry projects to improve efficiency and quality of output in the clinical development process. This reduces cost and optimises utilisation of resources.

Comprehensive Services to support your Clinical Development Strategy

StatisticaMedica’s expert Biostatistics Consultants provide high-level strategic consultancy services ranging from clinical trial design and protocol development to regulatory submission, including FDA/EMA meeting representation. Our broad range of regulatory biostatistics advisory and consultancy services includes:

  • Prepare and review regulatory agency meeting requests and biostatistical aspects of the briefing packages
  • Prepare for and participate in FDA/other regulatory agency meetings as a Senior Biostatistical Advisor on behalf of clients
  • Ensure that the clinical trial hypothesis is correctly and completely translated into a statistically logical and valid set of trial-specific statistical tests and analyses that meet the criteria for acceptance by the FDA/relevant regulatory authority
  • Confirm that the statistical design of the clinical trial is in line with the trial objectives
  • Assist with selection of primary and secondary endpoints
  • Ensure that the trial size is optimal to answer the clinical research question specific to the trial
  • Determine optimal format for analysis dataset creation (e.g., CDISC, non-CDISC) 

For further details on our Clinical Trial Design, click here.