Book a 1-1 with Emily

Book a 1-1 with Emily

Emily Wood

Head of Statistical Consultancy

Emily has over 20 years of experience as a Statistician in the pharmaceutical industry and a proven track record in leading projects across all clinical phases. Set up a free 15 minute chat with Emily to discuss how we can find a collaborative, flexible solution to fit your statistical needs.

BOOK A 1-1

Flexible and collaborative statistical 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 optimise 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.
  • Randomisation – Producing randomisation lists and advising on the most appropriate randomisation 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 Analyses – 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 – Modelling the relationship between exposure and response using non-linear models and non-linear mixed effect modelling.
  • 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 analyses, right through to the interpretation of the results.
  • Launch and CommercialisationGet the strategic and collaborative support you need to help maximise launch impact and ensure commercial success for your remedy.
    • Real World Evidence: We develop high-quality observational studies – both prospective and retrospective – to complement clinical trials with real-world data.
    • Strategic consultancy: We offer full-day, comprehensive strategic workshops to help you best prepare your remedy for launch. Avoid common pitfalls and understand the strengths and limitations of your trial data.
    • Strategic evidence planning: We partner with you to develop a keen understanding of how your new therapy fits into the existing medical landscape based on your company’s internal and competitive intelligence data.
    • Data mining: Our data mining and network meta-analysis services maximise the value of existing internal or external data.
    • HTA submissions: Our experience with HTA submissions on a global scale will help you to prepare HTA dossiers efficiently and to the highest quality.
    • Customer interactions: Ensure high quality interactions with all your external customers including key opinion leaders (KOLs), practicing physicians, key accounts, and patients.

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