End-to-End Biostatistics support for Clinical Trials :

Our cutting-edge expertise for better outcomes

Data Statistics

Clinical trials are the key part of any pharmaceutical research.

They provide they only way to test the safety and effectiveness of new drugs, treatments, and medical devices before they are made widely available to the public.

There are several stages of clinical trials, ranging from small, early-phase studies (phases I – II) that involve a few participants to large, late-phase studies (phases III – IV) that involve thousands of participants. Each phase has a different goal and helps researchers learn more about the product being tested.

Clinical trials generate evidence-based data on the safety and effectiveness of a new product, ensuring that only safe and effective treatments are made available to patients.

They also help researchers understand how a new product works in the body and how it is metabolized. This can provide important information on potential side effects and potential drug interactions.

Head-to-Head trials allow researchers to compare the new product to existing gold standard treatments and determine if it is more effective or has other advantages.

Our expert team in Biostatistics and Statistical Programming  provide full-service support in Clinical Trials data analyses, at every step of your research :

  • Design the study: We help your team to determine the appropriate study sample size, randomization scheme, interim analyses and all statistical methods needed to answer the research question.

 

  • Write the Statistical Analysis Plan (SAP): A Statistical Analysis Plan outlines the statistical methods that will be used to analyze the data collected during the study. We will work with your study team to develop a thorough and accurate statistical analysis plan.

 

  • Analyze the data: We use the adapated statistical software  (SAS or R) to analyze the collected data and provide insights into the study results.

 

  • Creation of the Tables/Figures/Listing (TFLs) : We provide high-quality TFLs with a format that helps readers understand and interpret complex datasets, and highlight key trends and patterns in the data.

 

  • Interpret the results: Our Biostatistician experts also help to interpret the statistical results of the study and provide guidance on how to communicate the findings to stakeholders.

 

  • Support the regulatory submission process: We provide support during the regulatory submission process, including preparing statistical summaries and responding to questions from regulatory agencies.
CONTACT US

SIGNIFIENCE

PariSanté Campus

2 – 10 Rue d’Oradour-sur-Glane

75015 Paris

contact@signifience.com