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Santé Active Edition – Synergy Pharm: Medical Writing Solutions

We have been serving the pharmaceutical industry, and more generally the scientific research community, for more than 30 years.

We work accurately and efficiently to meet your deadlines, while our compliance with international standards (CONSORT, ICH, etc.), systematic proofreading between medical writers, and attention to detail guarantee that your documents will be of the highest quality. Our adaptability and responsiveness lead us to develop privileged and ongoing relationships with our clients.

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MedComms Day

Today is MedComms Day! We would like to take this opportunity to tell you about our core business activity: medical and scientific writing.

Our medical communication agency has been serving the pharmaceutical and cosmetics industries, biotech companies, manufacturers of medical devices, healthcare professionals, and the wider scientific research community for more than 30 years. How? Medical communication, and particularly the writing of regulatory and clinical documentation related to the development of drugs and other healthcare products, is an integral part of these sectors.

  • Setting up a clinical study requires the submission of a Clinical Trial Authorization (CTA) application to the health regulatory authorities. Many documents need to be written for this application: an Investigational Medicine Product Dossier (IMPD), an investigator’s brochure, a synopsis and a clinical trial protocol, an informed consent form (ICF), etc. In addition, a Clinical Study Report (CSR) needs to be written after each trial phase to communicate the results to the regulatory authorities, and a lay summary must also be published in the European database of clinical studies.
  • Preparing a drug Marketing Authorization Application (MAA) also requires specific skills, involving the writing of a Common Technical Document (CTD, clinical and nonclinical), and a Pediatric Investigation Plan (PIP), if applicable. After submitting the MAA dossier, national (e.g., the French Agency for the Safety of Medicines and Health Products, ANSM) or international (European Medicines Agency [EMA], Food Drug Administration [FDA]) health agencies usually require detailed responses to answer specific questions about the drug being assessed.
  • Pharmacovigilance documents (e.g., Periodic Safety Update Reports [PSURs], Development Safety Update Reports [DSURs] are also essential documents that need to be written at various points during the “lifespan” of a drug.

Our team is passionate about scientific and medical writing: our profession is diverse and enriching with many various missions on many various themes!

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World No Tobacco Day

Did you know that tobacco is the main risk factor for bladder cancer?

In 75% of cases, bladder cancer is non-invasive but 5-year progression (0.8% – 45%) and recurrence (31% – 78%) rates are high. Patients with this type of cancer must therefore undergo regular examinations to enable early treatment.

Several urinary tests have been developed to overcome the drawbacks of reference examination methods;  in particular the invasive nature of cystoscopy, and the problems of sensitivity and of intra- and inter-observer reproducibility associated with cytology.

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Fight against Malaria

Malaria is caused by Plasmodium parasites. Among the 5 disease-causing parasite species, Plasmodium (P.) falciparum and P. vivax are the most widespread. They are transmitted to people through the bites of infected female Anopheles mosquitoes.

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