Our expertise

Non-clinical information

  It is a well-known fact that non-clinical pharmacology and toxicology reports, among other documents, are often written using a specialised scientific vocabulary. For instance, pharmacokinetics is a science which poses vocabulary difficulties for translators. Thanks to its wide experience, ARGOS Pharma has become an expert in the specific terminology used in this field.
Pharmacokinetics: See our article on the translation of the term “half‑life”

Clinical information

 

To enable appropriate decision-making on the safety, efficacy and value of a new drug, it is clearly of the utmost importance that the information submitted is of the highest quality. The three phases of clinical research usually take several years because each phase has a different goal. As a consequence, the information to be translated, which includes research protocols, phase I, II and III clinical trial reports, informed consents, expert reports, etc., is very cutting-edge because it is based on the research of new medical, biological or other concepts.

See our article on the term “Lapp lactase”

Quality information (chemistry, manufacturing and quality control)

 

Modules 3.2.S (active substance) and 3.2.P (drug product) of the CTD are increasingly important in the pharmaceutical sector, mainly because of safety issues. Moreover, as a result of globalisation, manufacturing operations may take place in different sites located in different countries (or even continents), turning control mechanisms into a real challenge for both health authorities and pharmaceutical companies, and therefore increasing the amount of documentation.

In addition to medical research which leads to the discovery of new drugs, manufacturing and quality control are two important aspects which give significant added value to pharmaceutical companies. As such, innovation is continuous in this area. Every year, new testing techniques (for assay, identity, separation, etc.) are discovered, improving control and therefore drug product safety.


One of ARGOS Pharma’s specialties is the translation of technical dossiers on drug product quality.

 

In pharmaceutical translation, there is a trend to favour the clinical part at the expense of quality information.
In my opinion, clinical research and quality are two equally important pillars for drug product approval.

Philippe Ciazynski, Co-founder and Managing Director of ARGOS TSP

 

Biostatistics: another of ARGOS Pharma’s specialties

 

Statistics play an essential role in the design and development of clinical trials, as well as in the analysis and interpretation of the results. The future of research in areas such as molecular biology and gene therapy lies in biostatistics and bioinformatics.

Since statistical concepts may be difficult to grasp, these disciplines can be truly challenging for translators who lack a mathematical or scientific background. Twenty years ago, the “biostatistics” section represented no more than five lines in a clinical trial protocol, while nowadays it takes several pages to explain methods chosen for data analysis and interpretation. Statistical analysis provides a framework for deciding whether a new drug is effective and safe, two key conditions for a market launch, thus explaining the importance of biostatistics.

 

Information technology has considerably contributed to the progress of mathematics, especially in the field of biostatistics. In clinical trials, statistics are becoming increasingly important for drug product approval due to the discovery of new concepts. Since most of the scientific literature about biostatistics is published in English, it is essential to perfectly understand state-of-the-art concepts when translating them into other languages.

 

The last 20 years have confirmed the value of prospective, controlled, randomised and double-blind clinical trials for drug product evaluation. The use of these kinds of protocols leads to a constant refinement of statistical methods and to an improved harmonisation of regulatory dossiers.

 

  ARGOS Pharma’s internal team understands biostatistics concepts in clinical trials thanks to its scientific background. Our passion for science enables us to keep abreast of statistical advances where, thanks to computer science, much progress has been made.