The field of biostatistics plays a fundamental role in shaping the future of healthcare and medical research. As medical technologies develop and become more complex, the need for advanced statistical analysis in clinical trials, diagnostics, and therapeutic development grows significantly. Biostatistics is central to interpreting vast datasets, ensuring the accuracy and reliability of clinical trial results, and guiding decision-making processes in the medical industry. By applying rigorous statistical methods, biostatisticians contribute to enhancing patient outcomes and advancing scientific knowledge, ultimately driving improvements in health and medicine.
Sarah Seppelt Baker, the Managing Director of Anatomise Biostats Ltd, has carved a path of innovation and leadership in the field. With a strong background in psychology, neuroscience, and biostatistics, she has become a key figure in providing tailored statistical services to the healthcare and med-tech industries. Her work bridges the gap between statistical theory and its practical applications in clinical research, making her a trusted expert for clients seeking to direct the complications of clinical trials. Sarah's passion for improving patient access to effective therapies has led her to specialise in supporting MedTech start-ups with advanced biostatistical solutions.
Anatomise Biostats is at the forefront of providing comprehensive biostatistical services, specialising in clinical trial design, statistical analysis, bioinformatics, and regulatory compliance. By offering customised solutions for the MedTech sector, the company ensures that each project meets the highest standards of accuracy and efficiency. Through a personalised approach, Anatomise Biostats leverages innovative methodologies to address the unique challenges of modern healthcare, enhancing the quality and impact of clinical research.
Below are the highlights of the interview:
Can you share with us your journey into the field of biostatistics and what inspired you to found Anatomise Biostats?
I was introduced to statistics during my undergraduate studies where I majored in psychology and neuroscience. I recognised the critical role of statistical methods across research disciplines. I was intrigued by the vast range of statistical methods and their importance across virtually all fields of research. My Master of Biostatistics was an opportunity to focus on statistics applied in a medical context and expand my technical knowledge. My foray into consulting highlighted the necessity for ongoing innovation in statistical methodology to address emerging challenges in evidence-gathering in clinical research.
Initially, I began with ad hoc statistical consulting for clinicians, typically analysing real-world patient data. The variety of different therapeutic areas I was exposed to highlight the dynamic nature of the field and motivated me to establish Anatomise Biostats. At the time, the integration of bioinformatics with biostatistics was not common in clinical trials, and emerging fields like data science were not yet as prominent. It is now clear that these multi-faceted approaches are not only beneficial but essential for managing the growing complexity of therapeutic solutions in MedTech.
What motivates you in your role as Managing Director, and how did you come to specialise in pairing med-tech start-ups with biostatistical services?
What underpins our work is a commitment to delivering the best possible outcomes for patients. This is achieved through supporting the work of sponsors in enhancing patient access to effective new therapies and diagnostics, an outcome which ultimately depends on the accuracy of clinical trials. For clinical trial results to be genuinely valuable, the study must be carefully designed, transparently reported, and replicable. The role of a skilled statistical team is, therefore, essential.
Statistical methodologies vary wildly across therapeutic areas and device types. As the nature of both therapeutic and diagnostic devices evolve, so must the methods we use to evaluate them. Taking an approach of adaptability is vital. This variety and challenge is what makes biostatistics such an exciting area to work in.
What are the core values and vision that drive Anatomise Biostats?
Integrity is our top priority. We are dedicated to upholding ethical standards and transparency in reporting to deliver honest and accurate statistical analysis.
Excellence is what we aspire to when it comes to client deliverables.
Collaboration, both within a project team and with our clients, is essential to achieving optimal outcomes. We take a client-centered approach us to understand and address individual needs with solutions personalised to the product and study goals.
We are driven by innovation, continuously adapting and fine-tuning our methodologies in line with the technology under evaluation.
Our vision is to elevate the quality and impact of research in healthcare and life sciences, ultimately improving patient outcomes and advancing scientific knowledge.
By applying our core values and pursuing this vision, we aim to build lasting, trust-based relationships with our clients. We are committed to advancing health and science through exceptional statistical analysis and consulting services.
How does Anatomise Biostats differentiate itself from other companies offering biostatistical services?
Anatomise Biostats provides a distinctive range of analytics services tailored to pre-clinical and clinical trial projects. Our offerings include biostatistics, statistical programming, bioinformatics - and, so far, to a lesser extent, complex adaptive systems modelling. This multidisciplinary focus and diverse network of expertise allow us to deliver more comprehensive and innovative solutions compared to traditional biometrics CROs.
As a smaller company, we take pride in offering a highly personalised approach aimed at close collaboration and customised solutions. Our primary goal is to extract insights from data using both conventional and innovative methods tailored specifically to the goals of the project.
Could you elaborate on the comprehensive biostatistical services offered by Anatomise Biostats? How do these services enhance the accuracy and efficiency of clinical research?
Our statistical analysis services are comprehensive, encompassing everything from basic descriptive statistics to advanced techniques, including Bayesian methods and complex modelling and simulation. This breadth is necessary to meet the evolving needs of modern clinical trials, supporting impactful research and informed decision-making.
Our process starts with a thorough consultation with the sponsor before study design and protocol development takes place. The more we can plan in advance, the more we can reduce bias and have a study that produces meaningful results.
Statistical programming in SAS and, increasingly, R supports the accuracy and efficiency of the biostatistics component.
Keeping the needs and standards of regulatory agencies in mind is pivotal to maintaining efficiency. Study designs and statistical analyses comply with the requirements of agencies such as the FDA and EMA, and this facilitates a smoother approval process. Detailed guidance in interpreting statistical findings ensures that insights are effectively utilised. Additionally, we develop training materials for biostatisticians targeted at the unique needs of MedTech.
How do bioinformatics, machine learning, and complex adaptive systems modelling play a role in your services?
These methods can complement traditional biostatistics approaches in certain situations.
We customise the application of bioinformatics, machine learning, and complex adaptive systems (CAS) modeling to address the specific needs of each project.
For example, bioinformatics techniques can be used to analyse omics data—such as genomics, proteomics, metabolomics, or transcriptomics—for biomarkers that influence disease progression, diagnostic targets, or treatment responses. Machine learning can be used to enhance diagnostic precision or predict patient outcomes by analysing a vast array of potentially competing factors. The relevance and effectiveness of these techniques depend on the quality and volume of the available data.
The uptake of CAS modelling has been slower but is particularly valuable for multi-system analysis when other methods fall short. This approach can hypothetically integrate data from various scales, such as molecular, cellular, tissue, organ, environmental, and economic levels. For example simulating long-term outcomes and understanding chronic effects. In medical device development, it could help with integrating multiple scales to improve device performance, modelling long-term interactions with biological systems, and refining designs for more effective and personalised healthcare solutions.
How do you identify and pair the right biostatisticians with specific med-tech start-ups or SMEs?
We adopt a strategic and personalised approach to aligning biostatisticians with our clients’ specific needs. Our process begins with a detailed consultation to understand the study’s goals and challenges, allowing us to optimise project aspects such as study design and set both short-term and long-term milestones.
When assembling a project team, we evaluate relevant technical skills, prior experience in the therapeutic area, and familiarity with the study phase to match the project’s requirements.
Our detailed technical expertise provides us with a nuanced understanding that distinguishes us from professional recruiters.
How does Anatomise Biostats ensure that the biostatistical services provided meet regulatory requirements?
Handling confidential data is a major component of our work, and we prioritise data security and regulatory compliance, including adherence to GDPR. We recognise the critical importance of safeguarding our clients’ intellectual property and patients’ sensitive information, and we have implemented stringent measures to protect it.
We adhere strictly to GDPR guidelines and maintain comprehensive records of our data processing activities for transparency and accountability.
Data is stored on secure servers with advanced encryption to protect it during transmission, use, and storage. We maintain an audit trail to track all data access and modifications, enhancing transparency. User management is crucial; access controls are in place to ensure that only authorised personnel can access client data, and only when necessary.
Our services also support clients in meeting regulatory requirements during product development, as accurate biostatistics is essential to this process.
Before new therapeutic devices or diagnostics can be introduced to patients, they must demonstrate compliance with regulatory standards for safety and efficacy. This is achieved through pre-clinical and clinical trials. For the evidence from these studies to be reliable and accurate, the study design must be well-thought-out bias minimised. This expertise in study design and analysis is our core competency.
How do you integrate bioinformatics and machine learning into your approach to R&D and clinical trials?
We address each project on a case-by-case basis, tailoring our approach to meet the specific requirements of each client.
Bioinformatics plays a role in diagnostics and predicting patient responses to treatment. By employing multi-omics techniques, we can assist clients in uncovering valuable insights that drive diagnostic and therapeutic development. This supports the identification of diagnostic biomarkers, optimisation of device designs, and customisation of solutions for individual patients.
In diagnostics, particularly with methods like liquid biopsies, our bioinformatics expertise is useful in identifying key biomarkers. This capability aids in the creation of advanced diagnostic tools, leading to more accurate and personalised patient care.
What advice would you give to start-ups and SMEs in the med-tech sector seeking biostatistical services?
Begin engaging a biostatistician as soon as possible. Early involvement allows them to address opaque statistical and study design factors that could affect the entire clinical study protocol, including site selection and patient recruitment. By addressing these considerations upfront, you may avoid the need for protocol amendments later in the process. Keep in mind that this is a collaborative effort; evolving feasibility factors will also impact the statistical design of the project.