Execute your clinical research project with greater clarity, efficiency & accuracy.
Biostatistics expertise for the design & analysis of your R&D and clinical trials.
Biostatistics is the application of statistical methods to biological, biomedical, and public health research. In clinical trials, biostatisticians are responsible for planning study designs, determining sample sizes, developing randomisation schemes, and conducting statistical analyses of data collected during the study. Application of correct biostatistical methods in these areas ensures that a clinical study is appropriately powered to detect meaningful effects, and the the data analysis is able to draw valid conclusions about the efficacy and safety of the interventions being studied. Biostatisticians also help interpret the results, assess the statistical significance of findings, and communicate the outcomes to the research team and regulatory authorities.
Biostatistics help for R&D or exploratory studies
Whether you are a pharma or medical device start-up or SME, the analysis of early-stage testing and the biostatistical design of pre-clinical R&D studies for your therapeutic can help to provide insight and pre-clinical validation sufficient for entry into clinical trials. We can also perform initial research and comparative studies of existing therapeutics as a preparatory step towards evaluating the efficacy and safety of a novel therapeutic under development.
Biostatistical design & analysis of pharma & medtech clinical trials
Up-to-date biostatistical methods and clinical study design techniques ensure that your research is as innovative as your therapeutic. Assistance in the development of a statistical analysis plan for your trial, including sample size calculations, adjustments for missing data, and establishing early-stopping conditions are just some of the ways our biostatistical expertise could add value to your project.
Biomarker-related components can be woven into your clinical trial alongside traditional biostatistical approaches. Particularly in the context of pharmaceutical therapeutics, biomarker-guided clinical trials allow a novel therapeutic to be tailored to the patient, or a study population to be restricted to specific biomarkers. In either case, this increased precision improves the chance of a successful trial and allows treatment efficacy to be more clearly determined.
An adaptive clinical trial design, in the case of medical device trials, ensures that modifications can be made to your device during the trial. For pharmaceutical trials, they provide the flexibility to end an unproductive trial early or update treatment doses without running subsequent dose-finding trials. These services can help to establish the reasonable assurance of safety & effectiveness for your therapeutic.
Biostatistics Services for Pharma Start-ups & SMEs
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Biostatistics Services for MedTech Start-ups & SMEs
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We help you to develop and implement a clear plan of action from the outset of your project to ensure you remain on your optimal trajectory for the project duration.
In the initial stages we refine you research questions, fine tune your hypotheses for precise testing and enable a statistical analysis plan that optimizes your study results. Study power and required sample size can vary wildly as a function of statistical test and data type. Determining a statistical analysis plan up front is key as it enables us to calculate the most appropriate sample size and power for your study.
We advise on data collection and inputting techniques that reduce the need for data cleaning and preparation at the analysis stage, whether STDM and ADaM for clinical trials or the collation of RWD for modelling purposes. This helps to streamline the study process and enables a more efficient investigation of your research questions.
We use a rigorous approach to ensure the most appropriate statistical methodology has been implemented at the final analysis stage. We will fine tune your statistical analysis plan as needed in line with any unexpected developments arising from the nuances of real-world data. We follow protocol to ensure your final analysis is as accurate and free from bias to every possible extent. We then write up the results of your study and guide your interpretation to fully ensure that any conclusions are correct and concise.
Benefits of outsourcing biostatistics services for med-tech start ups and SMEs
Outsourcing biostatistics services can offer numerous advantages to med-tech start-ups and small to medium-sized enterprises (SMEs) engaged in R&D, product development, and clinical trials. Here are some of the key benefits:
- Specialised Expertise: Biostatistical consulting firms possess highly specialised expertise in the design and analysis of clinical trials. By outsourcing to these firms, start-ups and SMEs can tap into the knowledge and experience of seasoned biostatisticians, ensuring their studies are robust, statistically sound, and compliant with regulatory standards.
- Cost-Effectiveness: Building an in-house biostatistics team can be expensive for smaller companies. Outsourcing allows start-ups and SMEs to access top-notch biostatistical services without the overhead costs associated with hiring and maintaining a dedicated team.
- Access to Adjacent Experts: In the case of Anatomise Biostats, adjacent experts such as statistical programmers, bioinformaticians, data scientists can be added to projects without the hassle and cost of sourcing, recruiting and managing multiple temp employees or contractors to internal teams. This means that a project benefits from a broader range of experts at an expense that is limited to input needed for the project at hand.
- Faster Study Start-Up: Biostatistical consulting firms are well-versed in the intricacies of clinical trial design and planning. Their expertise streamlines the study start-up process, reducing delays and accelerating the time to market for novel therapeutics.
- Optimized Resource Allocation: Outsourcing biostatistics services enables start-ups and SMEs to focus on their core competencies, such as R&D and product development. It allows them to allocate their resources efficiently while leaving the complex statistical aspects of clinical trials to experts.
- Improved Study Design: Proper study design is crucial for obtaining meaningful results. Biostatistical consultants can guide start-ups and SMEs in choosing the most appropriate study design, sample size calculations, and statistical analyses, increasing the likelihood of successful outcomes.
- Mitigation of Risks: By working with experienced biostatisticians, start-ups and SMEs can identify potential risks and challenges early in the planning phase. This proactive approach helps mitigate risks and ensures a smoother trial process, reducing the likelihood of costly mistakes.
- Regulatory Compliance: Anatomise Biostats is well-versed in regulatory requirements and industry standards. Outsourcing biostatistics services to us ensures that clinical trials are conducted in compliance with relevant regulations, streamlining the regulatory submission and approval process.
- Data Quality and Integrity: Biostatistical consultants play a vital role in data quality and integrity, including monitoring data for inconsistencies, missing values, and outliers. Their involvement enhances the reliability and credibility of the study results.
- Interpretation of Results: Biostatisticians possess the skills to interpret complex data, providing valuable insights from clinical trial outcomes. Their expertise helps start-ups and SMEs understand the significance of study findings and make informed decisions for future development strategies.
- Flexibility and Scalability: Outsourcing biostatistics services offers flexibility, allowing start-ups and SMEs to tailor the level of support to their specific needs. As projects evolve, the scope of biostatistical services can be easily adjusted, providing scalability without long-term commitments.
Outsourcing biostatistics services provides med-tech start-ups and SMEs with access to expert knowledge, cost-effective solutions, and streamlined trial processes. By leveraging the expertise of biostatistical consulting firms, companies can enhance the quality and efficiency of their clinical trials, facilitating the successful development and market entry of their novel therapeutics.
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