statistical consultancy services

Veramed provides a comprehensive statistical service, from study design through to submission and beyond.

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 analyses, or strategic advice when entering post trial submission, we’re are 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.

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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

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.

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Broad experience

Our experts combine knowledge in innovative statistical design and analysis, RWE, HTA, data visualisation 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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CONTACT

Have you found what you are looking for? Learn more about our other services below or get in touch.

Study Reporting & Analysis

We offer a range of outsourced and insourced Study Reporting & Analysis services.

Data Monitoring Committees (DMC)

We provide a wide variety of DMC offerings, from one-off consultation to full end-to-end Statistical Data Analysis Centre with administrative and logistical support.

Functional Service Provider

Our bespoke FSP relationships allow us to partner with you to understand your requirements, build trust, enhance quality and develop long-term, collaborative relationships.

Launch & Commercialisation

We will support you with a range of strategically-focused, collaborative services that help maximise launch impact and ensure commercial success.

Biotech Due Diligence

A Veramed & Weatherden partnership, we offer data driven due diligence of your assets to help you better seek potential acquirees or partners.

Automation

Our Automation, Efficiency and Standards group helps you to assess, evaluate and implement enhancements to your clinical trial workflows.

The team are competent statisticians and programmers, but also personable and friendly and very easy to work with. We have full and frank communication, we work as closely with them as if they were internal staff.

FSP client since 2017

Many thanks to all of you for your hard work on these outputs. I don’t think I’ve ever done QC with so few comments. It's been a pleasure to work with your excellent team.

Client since 2015

I am very impressed at your professionalism and very grateful for your careful and effective management of this significant project issue. Many thanks for your hard work.

FSP client since 2018

I knew you guys were good. That’s perfect. Not every vendor is. The SAP and shells were in very good shape if those are my only 3 comments about those two documents. You did a wonderful job.

FSP client since 2018

Functional Service Provider

Study Reporting & Analysis

Biotech Due Diligence

Data Monitoring Committees (DMC)

Launch & Commercialisation

Automation