News - Page 3

International Translation Day

Journée Internationale Traduction

September 30, 2021

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The CONSERVE 2021 Statement for reporting changes in studies

CONSERVE 2021 statement

September 7, 2021

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First International Neonatal Screening Day

International Neonatal Screening Day

June 28, 2021

Neonatal screening, also called newborn screening (NBS), allows the early detection and clinical management of newborns with a range of health conditions.

The date for this international NBS day was chosen in honor of Dr. Robert Guthrie, whose birthday is June 28th. In the United States in the 1960s, Dr Guthrie developed the first NBS test for phenylketonuria (PKU), using a drop of blood collected on blotting paper. This blotting paper technique is still used today in all NBS programs. The blood sample is usually collected in the first 3 days of life from the newborn’s heel, or sometimes from their hand.

Technological advances now allow the screening of up to 50 disorders from just a few dried blood spots! Most of these are congenital metabolic disorders and endocrine disorders.

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World Microbiome Day

World microbiome day

June 24, 2021

June the 27th is World Microbiome Day. This yearly event aims to raise awareness of the diversity of human, animal and environmental microbiomes, and of their effects on health.

Our medical writers at Santé Active Edition – Synergy Pharm have participated in the writing of several scientific articles and reviews on the skin and intestinal microbiomes, highlighting their vital importance for human health, most notably in acne, atopic dermatitis, rosacea, wound healing, and in intestinal disorders. In addition, microbiomes in the environment play a fundamental role in maintaining the balance needed for healthy ecosystems.

MedComms Day

MedComms

June 9, 2021

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!

World No Tobacco Day

World No Tobacco Day

May 31, 2021

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.

Fight against Malaria

Fight against Malaria

April 27, 2021

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.

Medical articles, preprints, and peer review

AMWA-EMWA-ISMPP_Publications

April 15, 2021

Updated PRISMA guidelines

PRISMA 2020 statement

March 30, 2021

Every medical writer at Santé Active Édition – Synergy Pharm pays particular attention to keeping informed of new medical writing recommendations, including those concerning medical and scientific article writing.

Our Contributions to Publications on Memory

Nos réalisations sur la mémoire

March 15, 2021