Clinical trials | medicine | pharmacy
Clinical Trials? Sure!
• Our medical translators are only MDs and PhDs. Many have clinical experience or clinical trials background
• We are aware of what the trials are, both being study site’s Investigators or clinical study unit’s associates in pharmacological companies. We are familiar with GCP, GLP, GMP and other GxPs
• Mere translation is not our way. Being involved, we deeply read your materials, and we are pleased to find any discrepancies, if any. Wу are proud to have initiated some protocols’ amendments after revealing some mistakes contained therein
• Our Certificates of Translation contain full and correct names of documents, not just ‘MHRA approval’ which impels a complete re-do before an FDA inspection
• We respect your pass-through expenses
• We know that time is an issue. Especially pressing time. Rely on us
• We blind discharge epicrises within urgent SAEs translations
• We know how the drugs are manufactures.
• We are experienced with medical equipment
• We notarize pares
• When billing the invoice, we split the costs for your convenience
What is our working practice?
Carefully. When translating protocols for clinical trials, we do not discard “extra” lines from the study flow-chart. We do not forget to put a tick in front of the ECG where it should be on the "Week 36" visit. We do not confuse the document versions in the footers. We blind the names and details of patients in the discharge records. We carefully and completely translate all footnotes describing procedural assumptions or any issue "at the discretion of the investigator."
Thoughtfully. Clinical trials experience of being the Investigators and Big Pharma associates clearly shows that the researcher's brochure, clinical study protocol or laboratory manual require deep reading, not just mere translation.
Qualitatively. We do our job well. We are pleased to make doctors comfortable working with our translated materials. We are happy if there are no discrepancies in the instructions for the equipment. We are happy when CRAs in other countries use local versions of the protocol with no worries to find any mistake there. We are frank and open. That’s our essence
We can deal with
Investigator brochures, Informed Consent Forms and their back-translations, study protocols and their amendments and track-changes, submission letters to regulatory authorities, discharge epicrises, safety reports (DSUR, PSUR), clinical study reports (CSR), and others types of documents that are essential for CROs and Pharma. For sure, we are familiar with any documents included in the dossier upon initial submission to Regulatory Agencies: preclinical data, stability studies’ results, certificates of analysis, of manufacturing process description, GMP certificates, etc. On top of that we can render an urgent translation of a SAE-package documents (medical extracts, death certificates, autopsy reports, examination results, etc.) i.e., everything that the Sponsor may request as part of the accompanying documents to the SAE.
Our qualification
Our associates have medical education, clinical trials experience, are familiar with medical equipment; also, some translators are fond of veterinary medicine, aesthetic medicine, cosmetology, etc.
Upon your request, we can prove our qualifications providing you with the diplomas, medical licenses, GCP certificates, etc.
Experience determines the work. In other words, rheumatological protocols are translated by rheumatologists, and oncological - by oncologists.