Biostatistical Services

The FDA shoulders high responsibility for ensuring the protection of public health by assuring the safety, effectiveness and security of drugs, and other biological products. The Pharmaceutical industry produces and markets licensed drugs for medical usage. They are subjected to various laws and regulations in ensuring the patenting, testing and marketing of drugs. The Life Sciences industry is dependent on reliable data to run clinical trials and get quick approvals on drug safety and effectiveness. The role of Biostatisticians has become imperative in delivering appropriate statistics to increase the chances of successful trials, create precise clinical study reports and perform various data monitoring analysis to maintain data safety and integrity.

Element’s services aid biostatisticians with access to accurate information that complies with the current regulatory standards. The data can be quickly and readily reported that leads to successful clinical trials and faster drug approvals. We have great expertise in the SAS platform, and our clientele is a testament to our years of experience in delivering successful analysis and reporting on various clinical studies across different therapeutic areas.

Biostatistics, Clinical SAS Programming, and Program Management:

  • Statistical input to Protocol
  • Sample size Estimation
  • Randomization
  • Development of SAP and Mock TLF shells
  • Statistical section writing for CSR
  • Safety & Efficacy Analysis and Reporting
  • Interim Analysis
  • PK/PD Analysis
  • Exploratory Analysis
  • Meta-Analysis
  • Analysis Dataset (ADaM/Sponsor defined) creation
  • QC of analysis and reporting
  • Integrated Summary Support (ISS/ISE)
  • Integration of data
  • Analysis and Reporting
  • Application development (SAS Programming)
  • SAS Visual Analytics (Authorized SAS partner)
  • SAS installation and administration support (Authorized SAS partner)



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    Biostatistics Consulting Services


    Public health is closely related to using statistical data in the healthcare industry. The quantity of information that can be used to explain healthcare choices and the application of data science in the medical field has given the industry a boost, unlike anything else. In addition, biostatistics is crucial for public health because it helps scientists make judgments about patient care while maintaining a single-minded focus on the study area. This makes it important for scientists to utilize its potential fully. The data set will also make sense as a whole.


    Decision-making requires a thorough understanding of the statistical and scientific ideas involved. But how effective is biostatistics in the medical field, and how can we convey its significance in actual situations? All basic questions about biostatistics have their answers here. 


    What Exactly is Biostatistics?


    Biological and statistical issues are covered in biostatistics. Conventional statistical methods are used for accuracy in clinical trials and public health. Biostatisticians are the brains behind this interdisciplinary endeavor. Along with being science specialists, they are also keen observers of deficiencies. They provide information about a disease’s cause or if a particular therapy is effective. A progressive viewpoint is also necessary to obtain the desired data from data clusters.


    To put it simply, a biostatistician is a force behind transforming public health data into an application-friendly format.


    We can assist you with your research from initial concept to final writing by using biostatistics clinical trials & clinical biostatistics services.


    Biostatistics in Clinical Research and Public Health: A Critical Perspective


    Because of biostatistics, clinical researchers can now use the data at their disposal to make references. Biostatistics assists the field of clinical research in various ways, from trial design to protocol creation. Just a few examples are shown below.


    Development of the study framework’s design


    Element Biostatisticians are typically brought on board in the beginning stages of clinical research studies to help the research team analyze the goals, techniques for data analysis, and overall study design for a better outcome. For example, the sample size is crucial for a research design example.


    The research results that use a small sample size may not be satisfactory. A big sample, on the other hand, would be a waste of time and money.


    Surveillance and Control of Data 


    Biostatisticians, who also identify potential problems with data gathering, aid the development of data management strategies. In collecting and analyzing data, this, unfortunately, adds much tangibility. 


    Analysis of the data and Reporting


    Biostatisticians use statistical tools to analyze the data they have collected as part of a clinical research study to draw conclusions and identify any unexpected data trends. As part of the collaborative process between biostatisticians and researchers, clinical research reporting includes statistical methodologies, the approach’s briefing, data interpretations, and visual depiction.


    Applications of Biostatistics


    Regarding Anatomy and Physiology 


    • Determine what constitutes a population’s normal or healthy behavior.
    • To determine the upper and lower bounds of normalcy for population-level variables like weight and pulse rate. 



    • To determine a drug’s effect, it is administered to humans to ascertain if any changes are brought about by the medication or by coincidence.
    • To contrast the results of two doses of the same medicine or two doses of a different drug.
    • To determine a new drug’s relative potency compared to an existing one.

    In Medicine 


    • Statistical approaches are used to compare the proportion of patients who were healed, alleviated, or died in the experiment and control groups to determine if there was a difference that might have been explained by chance or another factor. 
    • To fix if there is a relationship between two characteristics, such as cancer and smoking or filariasis and socioeconomic status. 
    • To recognize sickness or condition symptoms and indicators. 
    • Typhoid cough is a chance finding, although fever is virtually always present.
    • The percentage of assaults or fatalities among the vaccinated participants is compared to that among the unvaccinated patients to determine if the difference observed is statistically significant.

    Clinical Medicine


    • The recording of illness histories in medicine.
    • Clinical study design and execution.
    • Analysing the advantages of various methods.
    • By offering approaches for defining what is “normal” and “abnormal,”


    The biostatistics consulting services can handle any project needing knowledge in a statistical field. 


    Using Biostatistics to Improve the Provision of Patient Care


    Finding practical solutions to cut expenses associated with the clients who use their services the most is one of the biggest difficulties confronting the healthcare industry. The U.S. Department of Health and Human Services highlighted research showing that 5% of patients incur 50% of all expenses and that 1% of patients treated in U.S. healthcare institutions account for more than 20% of overall costs.


    Biostatistics may help doctors with information on when to deliver preventive and targeted therapies, lowering the expenses associated with incorrect diagnoses or ineffective treatments. This is done by identifying expected outcomes. A paper issued in the Journal of Mental Research, for instance, proposes a “precision medicine” framework that develops tailored predictions about the psychiatric symptoms and events that patients are expected to encounter based on a thorough examination of their current symptoms.


    In the first stage of the framework, a Bayesian hierarchical model determines a trajectory for all symptoms and outliers representative of the population as a whole. The second stage involves applying a different model to each patient’s unique symptom trajectory to determine the chance that the patient will have that symptom in the future. For example, in a case study involving the treatment of schizophrenia that aimed to forecast the risk that the treatment plan would fail for specific individuals, the framework obtained acceptable predictive accuracy. With the help of this biostatistical tool, doctors may provide a patient-specific treatment plan that is likely to have a good impact.


    The Biostatistics consulting services can handle projects needing knowledge in any area of statistics. We can assist you with your study from the initial planning phases to the final write-up using biostatistics clinical trials & clinical biostatistics services.