Schema Post AMM Studies EN


Formerly a major element of the pharmaceutical company’s marketing mix, post-marketing studies have now acquired a medical and scientific dimension which makes them part and parcel of the study process in the wake of pre-marketing studies of phases I, II and III.

Regulations extended to medical devices 

These studies focus mainly on watching out for the efficacy and the safety of the product and are included in the risk management plan required by the FDA and the EMA.

  • Regarding drugs, the FDA set up in 2009 a research fund related to "comparative efficacy" data, and in Europe, the EMA initiated in a first time risk management plans and more recently, the possibility to require studies on efficacy in real conditions of practice. 

  • Regarding medical devices (MD), the 2007/47/EC European guideline reinforces the need for manufacturers to provide clinical data. Consequently, a clinical follow-up after marketing must be implemented in order to collect additional data.

Laboratories are therefore requested to track, from a quantitative and qualitative perspective, all the side effects events likely to occur during the product use in real life and on a large population.

The tracking is quantitative if the side effect sought after has already been highlighted in pre-marketing studies and is qualitative for side effects unknown up to this stage of development.

Thus the emergence of those so-called « post-registration » studies whose aim is to collect additional data on epidemiological, clinical and economical aspects in real clinical practice.

Three development goals for post-marketing studies 

These studies are necessary :

  • when evaluating a health product to determine its reimbursement 

  • when renewing its reimbursement by the social health insurance 

  • when registering a medical device on the List of Products and Services Coverage (LPPR). 

So as to deal with these evolutions in the post-marketing assessments of drugs and medical devices, ICTA offers an expertise based on its experience in study design and full-service management of European post-marketing studies.

During the design phase, ICTA's expertise lies on its cross-departmental organisation where medical, scientific and biostatistical skills develop innovative study designs which stem from methodological approaches suited to the study objectives. The operational management of the study is ensured by dedicated teams who benefit from a powerful CTMS developed by ICTA via the in-company platform called i-SIT.

  • R&D consultancy
  • Design
  • Regulatory affairs
  • Logistics
  • Project management / Monitoring
  • Data-Management
  • Biostatistics
  • Modelling
  • Study report
  • Pharmacovigilance
  • Publications
  • Pharmaco-epidemiology
  • Observatories
  • Registries
  • Cohort studies
  • Case control studies

  • Pharmacoeconomics
  • Piggyback studies
  • Cost / utility studies
  • Cost / benefit studies 

  • Phase IV clinical studies
  • PASS* and PAES**
  • Frequentist
  • Bayesian
  • Mixed
  • Bootstrapping

* PASS: Post-Authorisation Safety Studies

** PAES: Post-Authorisation Efficacy Studies