Medical and Regulatory Affairs

Headed by a MD with Cardiology training and 20+ years of experience in Clinical Research and Product Development. The Department of Medical Affairs includes 5 MDs and oversees:

Clinical writing :
Medically qualified professionals bring their experience in protocol design and writing, Investigator Drug Brochure compilation, Clinical Report and Integrated Reports writing.
Clinical writing is typically performed in English with  proof-reading performed by a native English speaking Clinical Assistant, or in other European languages whenever necessary (French, Spanish, Italian, German...).

Safety review :
Safety review includes systematic medical review of Case Report Forms, Adverse Events analysis, Serious AE notification and follow-up, writing of safety summaries and safety reports, patient profiles, etc. whenever appropriate. A medical officer is always committed to a monitoring project for permanent safety surveillance and medical support to investigators and CRAs. The medical monitor has a pivotal role in preparing submission package to Ethical Committees (Comité de Protection des Personnes), reviewing Investigator Brochure, Protocols, preparing protocol synopsis and summaries, preparing templates of Information Note to Patients and Informed Consent Form, etc.

Regulatory affairs :
Only regulatory activities related to clinical activities are performed, i.e. obtaining EuDRACT number, compiling Ethics Committee dossiers, submitting to IRBs/Ethics Committees, notifying health authorities, and maintaining the update of those dossiers.

ASCOPHARM NOVASCO Group has extensive experience in preparing and submitting package to E.C.s in France and in other European countries, under local and European regulation directives. The group has developed a solid network of relations within key Ethics Committees, in order to facilitate submission and communication with committees. Also, a large experience in preparing submission package and an important commitment of the medical team ascertain that dossier are well-prepared and that a very high level of confidence in obtaining approval is achieved.
Preparation of EC packages includes:

  • Reviewing of protocols, preparing synopsis and summaries in local language,
  • Compiling Investigator Brochure,
  • Reviewing drafts of CRF for submission,
  • Discussing with principal investigator and obtaining a letter of submission from him/her,
  • Preparing / negotiating / signing (whenever applicable) Insurance contract, and obtaining certificate of insurance,
  • Paying EC fees and obtaining legal receipt,
  • Submitting to European Authorities to obtain EuDract registration number,
  • Etc…

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