Safety Writing Services

Safe­ty Writing/Pharmacovigilance has evolved to be a dis­ci­pline of its own. With the new Euro­pean GVP leg­is­la­tion both process­es and doc­u­ments become stream­lined, which cre­ates a need for pro­fes­sion­al­ly com­piled and har­mo­nized con­tent. Util­is­ing pooled resources from the Med­ical Writ­ing and Phar­ma­covig­i­lance depart­ments, we have spe­cialised in pro­vid­ing qual­i­ty writ­ing, con­sult­ing and edi­to­r­i­al sup­port ser­vices for the cre­ation and main­te­nance of Phar­ma­covig­i­lance doc­u­ments. Our ser­vices cov­er phar­ma­covig­i­lance in the pre- and post-mar­ket­ing settings.

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Pharmacovigilance Services

  • Set-up & main­te­nance of val­i­dat­ed safe­ty databases

  • SAE/AE Report­ing

  • Expe­dit­ed Reporting

  • Month­ly Line Listings

  • Med­ical Safe­ty Reviews

Safety Writing Services

  • Devel­op­ment Safe­ty Update Reports (DSURs) / Annu­al Safe­ty Reports (ASRs)

  • Peri­od­ic Safe­ty Update Reports (PSURs) / Peri­od­ic Ben­e­fit Risk Eval­u­a­tion Reports (PBR­ERs)
  • Peri­od­ic Ben­e­fit Risk Eval­u­a­tion Reports (PBRER)
  • Risk Man­age­ment Plans (RMPs)
  • Adden­dum to Clin­i­cal Overviews (ACOs)
  • Sig­nal Man­age­ment Doc­u­ments (SMDs)
  • Patient nar­ra­tives
  • Ben­e­fit-risk assessments
  • Lit­er­a­ture search­es and appraisals

Use of VigilanceOne (eDrug Safety Database)

  • Devel­oped in coop­er­a­tion with the Ger­man reg­u­la­to­ry author­i­ties Paul-Ehrlich-Insti­tut (PEI) and Fed­er­al Insti­tute for Drug and Med­ical Devices (BfArM)

  • Com­pli­ant with ICH-E2B and require­ments of reg­u­la­to­ry author­i­ties (e.g. BfArM/PEI/EMA)
  • Sup­ports the E2B data exchange via the Eudravig­i­lance gate­way or oth­er E2B com­pli­ant gate­way interfaces
  • Offers exchange for­mats that guar­an­tee effi­cient data exchange between Vig­i­lanceOne and exter­nal receivers and reg­u­la­to­ry authorities

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