Statistical Sections for Regulatory

Statistical Sections for Regulatory

Statistical Sections for RegulatoryIn order to ensure the healthy growth of the pharmaceutical market, while encouraging innovation and research, the US Food and Drug Administration (FDA) has developed a series of comprehensive measures and management tools. After the preclinical study is completed, when the drug manufacturer has sufficient data to prove that the drug is safe, it is ready to submit an investigational new drug (IND) application to the FDA. If the FDA approves the IND application, a clinical trial (a study involving human subjects) is allowed to start.

In the process of research and development of a new drug, when the third phase of human trials is completed, a set of information can be issued to the FDA to apply for a new drug marketing license. The main purpose of the NDA is to ensure that the drugs listed are safe, effective and of controllable quality.

Application materials include Chemistry, Manufacturing and Controls (CMC) data, non-clinical pharmacology and toxicology data, human pharmacokinetics and bioavailability data, microbiological data, clinical data, safety data update reports, statistical data, case reports, related patents, samples, packaging and labels. Persuasive statistics are required when applying for NDA.

Our Services

Our statistical experts will help you to solve the statistical problems involved in the NDA submission process, as well as the statistical section of the Integrated Safety Summary (ISS) and Comprehensive Effectiveness Summary (ISE). Our statisticians can also solve the issues involved in the publication of the study, including statistical method design, data analysis and biometric related verification for you.

  • Security analysis

Factors affecting drug safety include adverse drug reactions, drug interactions, patient factors, and medical staff factors. Identifying and evaluating adverse events reported in clinical trials is an important step in safety assessment. In addition, safety data analysis work includes analysis of adverse event rates, risk-time assessment, exploration of potential differences between subgroups, and identification of risk factors associated with serious events.

  • Efficacy analysis

Our experts will help our clients with various efficacy analyses. For example, we are experienced in calculating drug effectiveness indicators: 1. Elimination half-life: the time required for plasma drug concentration to fall by half. Its length can reflect the elimination rate of drugs in the body. 2. Biological half-life: The time required for the drug effect to fall by half.

We guarantee the confidentiality and sensitivity of our customers' data. We are committed to providing you timely and high-quality deliverables. At the same time, we guarantee you cost-effective, complete and concise reports.

If you are unable to find the specific service you are looking for, please feel free to contact us.

1. Johnston, D. (1994) 'Demonstrating the effectiveness of the quality systems for an FDA pre-NDA approval inspection', Revista Brasileira De Medicina Do Esporte, 28(4), 991-995.
2. Yao, L. X., Li, M. Z., Dong, J. P., Shao, Y., & Zheng, Q. (2013) 'Evolution of FDA's NDA/BLA review process under PDUFA', Chinese Journal of New Drugs, 22(10), 1143-1156+1169.
3. Cocchetto, D. M. (2008) 'Best practices for communication between FDA and applicants during the NDA review cycle: a PhRMA white paper', Drug Information Journal, 42(1), 3-8.

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