Flexible and collaborative statistical support, from study to submission, and beyond
Whether you need full‑scale trial design, a dedicated statistician for short‑term analyses, strategic guidance as you navigate post‑trial submission or longer-term support to help you oversee the statistical and programming aspects of your trials, we tailor our support to meet your specific requirements.
Our high quality, collaborative approach provides you with access to
a robust network of industry experts that act as a trusted extension to your team.
Partnering with Veramed means more than just access to tailored solutions, it’s about gaining a collaborative partner dedicated to your success. Our approach is built on proactive listening and genuine partnership, ensuring that each engagement is shaped around your ambitions and the unique challenges you face.
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 of your team.
We provide rigorous project management and governance procedures and communicate openly so you’re always up to date with project developments. We also have extensive experience providing statistical oversight for deliverables from other vendors, and integrate into your study teams to ensure statistical integrity and regulatory compliance.
We bring extensive experience in innovative trial design and advanced methodologies, including adaptive and Bayesian designs, MMRM, multiple imputation, PK/PD modelling, and event‑time analyses, to optimize your study success.
In the fast‑moving biopharma environment, we understand the pressure our clients face and the need to be flexible. We can adapt quickly to your changing needs, providing on‑hand expert statistical consultancy support at a moment’s notice.
Smaller biopharma companies often lack dedicated in-house statistical teams or may not have the capacity to meet critical milestones such as moving into Phase 2 or preparing for submission. Others have internal statisticians but need additional, flexible support to address workload peaks or specialist requirements.
In many cases, you may not need the scale of ongoing support offered by a Functional Service Provision (FSP) model. Instead, what you need is access to expert statistical advice and delivery on a flexible, as-needed basis, like having a trusted member of your team available on speed dial.
Our statistical consultancy service gives you exactly that.
Here are four ways we typically support our clients.
WHEN
At the outset of a trial to ensure the design will generate the right evidence to answer the research question efficiently. Involving a statistician early helps select the most appropriate design, minimize risks, and maximize the chances of success.
WHAT
Provide input on traditional, adaptive, or Bayesian design options; deliver sample size estimates; and run simulations to assess the impact of different scenarios on trial size and length.
HOW
Flexible consultancy support, available at short notice, acting as a virtual arm of your internal team to advise and help with trial design.
WHEN
When you’ve outsourced statistical and programming activities to a CRO but still need to meet your oversight obligations as a sponsor. Independent statistical review helps maintain quality standards and reduces the risk of delays caused by errors.
WHAT
Review Statistical Analysis Plans, dataset specifications, and outputs; identify quality issues; and provide clear feedback to the vendor to resolve problems quickly and keep projects on track.
HOW
We provide statisticians and programmers at short notice to review deliverables and maintain quality and efficiency across projects of any size.
WHEN
For important interactions with regulatory agencies, such as design reviews, end of Phase 2 meetings, or submissions, where statistical expertise can influence successful outcomes.
WHAT
We prepare briefing materials, conduct simulations and scenario modelling to support proposed designs or analysis strategies, anticipate regulatory questions and prepare clear, evidence-based responses, and attend regulatory meetings (in person or virtually) to address statistical queries in real time and support successful outcomes.
HOW
Flexible consultancy from statisticians with direct experience in regulatory interactions, ensuring rapid, informed responses to agency queries. Support can be provided behind the scenes in document preparation, or directly in meetings.
WHEN
When you know you need statistical input but aren’t sure what type or level is required. This could include small tasks, like a sample size calculation or study design discussions, support with ad-hoc analyses to support posters, presentations or publications or advice on statistical queries that arise as part of your ongoing trials or study planning.
WHAT
We provide high-level strategic advice, targeted operational support, or both, matching the right statistician to each aspect of your study while ensuring a consistent study lead oversees the entire process. We adapt quickly to new or evolving requirements, scaling up or down as needed.
HOW
A tailored, cost-effective, pay-for-what-you-need service that gives you access to the right statisticians for the right amount of time, with costs aligned to experience level and skill set.
How Veramed statisticians supported a Sponsor by operating as an extension to its own internal clinical team and providing statistical oversight of third-party vendors.
Improve the efficiency of your clinical trial workflows using next-gen computing.
Ensuring your real-world data is interoperable, analytics-ready, and regulatory-compliant.
Validated solutions for transparent, compliant, and efficient analytics, submissions, and interactive reporting tailored to regulated pharmaceutical environments.
Statistical consultancy in clinical research involves expert guidance on study design, data analysis, and regulatory strategy to ensure scientifically sound and compliant trials. Consultants help sponsors make data-driven decisions throughout the trial lifecycle.
Veramed offers support across all trial phases, including study design, adaptive and Bayesian design, simulations, protocol development, interim analyses, statistical modelling, regulatory submissions, and publication planning.
Yes, Veramed has extensive experience in designing and implementing adaptive and Bayesian trials, helping sponsors optimise study efficiency and decision-making through advanced methodologies.
Veramed offers on-demand consultancy services that adapt to your changing needs, whether you require short-term support for study design;ad-hoc analyses or long-term statistical oversight and strategic guidance throughout your trial.
Veramed has extensive experience supporting clinical research in a range of therapeutic areas, with particular expertise in oncology, rare diseases, immunology, cardiovascular and vaccine trials.
Veramed traditionally works with clinical trial data, including complex data, and also has experience working with data from real world (RWE) settings.
