How we work

Outsourcing Your Biostatistics & other Data-related Services with Us

Our expertise can be outsources for both R&D and clinical trials projects. There are 3 ways of working with us:

  • Service subscription.
  • Project-based outsourcing
  • Functional service provision (FSP)

Each of these options may include biostatisticians, bioinformaticians, statistical programmers, other technical experts, or a combination of these domains. In all cases you will be introduced to the team members working on your data.

What is the difference between these 3 options?

Service Subscription

  • This option has similar elements to both project-based outsourcing and FSP.
  • The focus is not limited to a pre-specified project but on flexible availability for the contract duration.
  • Deliverables may or may not be well-defined in advance.
  • Anatomise Biostats takes full-ownership for deliverables which will benefit from the insights of our consulting team.
  • While total contract hours are pre-defined, hours spent on projects may vary week-to-week as needed.

Advantage: Full-availability to work on any biostatistics (or bioinformatics, as stated in the contract) tasks for the duration of the contract. This means you can request tasks that might be outside the scope of the original project deliverables. There is not need to have every task well-defined in advance. We have full ownership of the work which allows us to apply advanced methodology where necessary and optimise methods to get to your goals more efficiently. Additional team members with specific technical skills can contribute where necessary. Service subscription allows for flexible allocation of hours from week-to-week to vary availability with the eb and flow of project demands.

Disadvantages: While the cost is known up-front, the price of individual deliverables may be less tangible at the outset. Timelines may be less well specified in advance of the contract commencing.

Project-based Outsourcing & Consulting.

  • The project and specified deliverable is the focus.
  • While decisions will be made with the wider company goals and pipelines line in mind, deliverables will pertain to a specific project and be well-defined.
  • Pricing will be on a per project basis.
  • Necessary data will be received by us, stored on our secure servers for the duration of the project. Consultants and service providers, such as biostatisticians and statistical programmers, will be working in-house and remotely for us for the duration of the project.
  • While we do provide the option of pre-packaged deliverables, our project-based outsourcing is by no means limited to this. It is also possible to have a project contract completely tailored to your needs.
  • Anatomise Biostats takes full accountability for project deliverables.

Advantages: Clear deliverables, faster service, transparent cost. No need to set up required IT infrastructure, nor on-board contractors nor induct into your existing workflow systems.

Disadvantages: Service is limited to what has been pre-defined in the proposal. ad hoc tasks on other projects will require a re-negotiation of terms and possibly an additional cost.

Functional Service Provision (FSP).

  • The team member is the focus.
  • The service provider is embedded within the client’s existing biometrics team and is managed by the client.
  • Decisions will be made by the project team of the client with the wider company goals and pipelines in mind, not consulted on by Anatomise Biostats.
  • Deliverables will be similarly determined and may or may not be well-defined.
  • Pricing will be on the basis of contract duration and include an hourly rate.
  • The client must provide the IT infrastructure required for the duration of the project.
  • Consultants and service providers, such as biostatisticians, will usually be working remotely for the duration of the contract.
  • Weekly hours are consistent and are usually full-time equivalent.

Advantage: Data is kept on clients own servers. You have control and ownership of task QC.

Disadvantage: significant onboarding of contractors and integration into existing teams is required, as is the set-up and maintenance of all necessary IT infrastructure such as servers and software. Expertise limited by the individual contractor/s at the direction of your team.

Benefits of outsourcing biostatistical services for medtech and biopharma 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Optimised 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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 biostatistics expertise of Anatomise Biostats, companies can enhance the quality and efficiency of their clinical trials, facilitating the successful development and market entry of their novel therapeutic