statistical consultancy services
”Whatever your statistical consultancy needs are, whether you’re looking for short term input for a specific piece of work or a lead statistician to provide long term support to your study teams, we can find a flexible solution to meet your requirements.
Emily Wood, Head of Statistical Consultancy
Flexible and collaborative statistical support
We provide a wide range of flexible statistical consultancy services to suit your needs. Whether you require full-scale trial design, a single Statistician for short term interim analyzes, or strategic advice when entering post trial submission, we’re able to support your needs. Our high quality, collaborative approach ensures you with access to a robust network of industry experts that are able to act as an extension to your team.
Learn more about our process and how we’ve helped clients below.
- Setup activities
- Midstream activities
- Analysis and reporting
- Post reporting / Submission activities
- Regulatory Support
Setup activities
- Clinical study design – Supporting the clinical team to develop the right study design, whether that is a standard or novel design. Our statisticians have experience in both adaptive and Bayesian methods so as to optimize the probability of study success.
- Simulations – Providing study simulations to improve the understanding of how unknown factors may impact on the clinical trial results – endpoint variability, recruitment and drop out, treatment effects, and so on.
- Protocol – Statistical support in the development of the clinical trial protocol (and amendments) with consideration to the recent ICH E9 addendum around estimands.
- Randomization – Producing randomization lists and advising on the most appropriate randomization method for a particular study.
Midstream activities
- Vendor oversight – Providing third party vendor oversight by managing timelines and reviewing statistical deliverables to ensure the highest quality for your trial.
- Interim Analyzes – Offering expert advice on the design, management and implementation of an interim look at the data, whether blinded or unblinded.
- Data Monitoring Committee Services – Our experience and expertise, combined with our processes, planning and technologies mean we can be trusted to seamlessly and independently service a DMC on your behalf, delivering with quality and integrity – on time.
Analysis and reporting
- Statistical Analysis Plans – Developing and/or reviewing clear and detailed SAPs and supporting mock output shells, in accordance with ICH E9, for clinical study reports, interims and DMCs.
- Statistical Analysis Expertise – Our statisticians have experience across most common and advanced statistical methodologies. Of particular note:
- MMRM – Extensive design experience of fixed and mixed effects models across phases and indications. Experience in handling non-convergence of models and assessing the best choice of model options.
- Multiple Imputation (incl. Pattern Mixture Models) – Experience of various types of missing data models, including hot deck imputation and tipping point methods.
- Multiple Testing Strategies – Knowledge in applying hierarchical testing due to multiplicity. In-house statistical expertise in assessing strategies to control type I errors in adaptive designs and standard trials, along with experience of closed testing procedures to illustrate type I error control.
- Multiple Failure Time Models – Application of Poisson, zero-inflated Poisson and negative binomial event models.
- PK/PD analysis – Modeling ling the relationship between exposure and response using non-linear models and non-linear mixed effect modeling.
- Clinical study reports (CSR) – Supporting the development of the clinical study report to ensure the statistical accuracy of the conclusions drawn from your study.
Post reporting / Submission activities
- Integrated summaries of safety & efficacy (ISS/ISE) – Guiding and assisting in the integration of safety and efficacy data across multiple studies prior to regulatory approval.
- Publication planning – we provide support throughout the publication process, from the concept, identification and implementation of appropriate analyzes, right through to the interpretation of the results.
Regulatory Support
We can provide expert input into regulatory support for strategic planning as well as support for regulatory submissions and other interactions, including:
- Review and input into briefing documents and other materials
- Involvement in meetings with regulatory agencies
- Supporting ISS/ISEs
- Responses to regulatory questions
Adapting to fluctuating demands
The bio-pharma industry is becoming increasingly fast-paced and demanding, causing sudden and even extreme changes to business and clinical trial needs. We understand the pressure our clients face and need to be flexible and adaptive to project needs, which is why we are able to provide on-hand expert statistical consultancy support at a moment’s notice.
Get in touch today to learn more about our flexible and collaborative approach to statistical consultancy.
Broad experience
Our experts combine knowledge in innovative statistical design and analysis, RWE, HTA, data visualization and more with the business understanding needed to help you build strategic solutions.
Range of skills
We pride ourselves on combining innovation with technical expertise, business and therapeutic understanding. In providing a diverse range of skills, we seamlessly act as an extension to our client’s teams.
Rigorous oversight
We have rigorous project management and governance procedures in place and communicate openly and honestly with clients so you’re always aware of progress and up to date with the latest project developments.
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