Discover the power of statistics

Getting your new medicine, medical device or diagnostic product over the finishing line of market access and reimbursement requires solid statistical evidence all the way. Numerus are experts in the analysis of data from randomised clinical trials, observational studies and real world data sources. Our team has a wealth experience helping clients answer thorny statistical questions from regulators and payers.

Contact us to find out how we can help put wind in the sails of your development programme.

Nurse administers IV drug to clinical trial subject

Phase I-III development

Randomised controlled trials (RCTs) are the gold standard in the evaluation of treatment efficacy in medical investigations, however only if designed and implemented well.

Support from study design to CSR

Market access and reimbursement is the new fourth hurdle

Health technology assessment

Commonly referred to as the "fourth hurdle", the efforts needed to achieve market access and reimbursement can be formidable.

Compelling additional benefit narratives

Real world evidence for healthcare decison making

Real world
evidence

Real-world evidence (RWE) has established itself as an important tool for global regulators as they look for new and innovate ways to inform healthcare decision-making.

Unlocking the value in your data

Safeguard your phase I-III development

Statistics play a vital role at every step of the clinical trial and drug development process, from study design and strategies, analysis of study data to the interpretation and reporting of results. Our biostatisticians are there to support you from the outset, carefully reviewing your study’s unique needs and determining the most effective way to analyse and present your data.

With more than a hundred years collective industry experience, Numerus's statisticians excel at combining creative thinking with their in-depth experience in the design, analysis and reporting of clinical trials. As you would expect, our work is performed according to ICH-GCP, regulatory standards and our own rigorous internal operating procedures.

Study synopsis / protocol development
Clinical trial simulation
Sample size calculation
Statistical analysis plan
Statistical / SAS / R programming
Clinical trial reporting
Interim analyses / statistical monitoring
DMC / DSMB support

Clear the hurdles to market access and reimbursement

Demonstrating to regulatory agencies a product's safety, efficacy, and quality is no longer sufficient. Manufacturers are required to evidence both clinical effectiveness as well as cost-effectiveness to ensure success in the marketplace.

To develop a compelling additional benefit narrative, Numerus combines the rigorous statistical principles and process associated with randomised clinical trials with the methods of health economics in a unified regulatory approach. The resultant robust analyses provide a solid foundation for submissions to the HTA authorities.

Generating the needed evidence for reimbursement requires forethought in early phase clinical study design. Numerus provides expert advice on the appropriate analyses to integrate into your study and provides direction in how best to address available HTA guidance.

Clinical trial data aggregation
& reanalysis
Evidence synthesis
Feasibility assessments
Meta-analysis
Network meta-analysis / Indirect treatment comparisons
Matching-adjusted indirect comparisons
Treatment switching adjustment
Investigational / unplanned analysis of clinical data

Maximise your data’s potential

Exploiting the potential of your real world data requires the use of robust and frequently complex statistical methods. Oftentimes organisations have collected or gained access to large amounts of unique and valuable data but lack the resources or skills to unlock the value within it.

Our statisticians have broad experience analysing data from a wide range of real world data sources. They are excited to take on new and challenging projects involving complex modelling and simulation methods. They have the statistical skills, imagination and flexibility needed to maximise your data’s potential and turn your real world data into real world evidence.

Real world data analysis and reporting
Disease / drug registries
Post-approval safety / efficacy studies
Medical records / claims database analysis
Publication support

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