Our research commitment

As partner of the ENCePP network, ApHER is committed to providing reliable results based on sound and scientific handling of data, from data management to the reporting of study results.

The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) is a network coordinated by the European Medicines Agency (EMA). The ENCePP network has produced a number of outputs, which ApEHR uses during conduct of PAS studies. This includes a checklist for study protocol conducted in accordance with the ENCePP Code of Conduct.

Since 2011, ApHER has been a research centre in the ENCePP network. ENCePP provides a unique opportunity for collaboration to improve pharmacoepidemiological research and post-authorisation safety surveillance of medicinal products in Europe through access to a robust network of resources working in a transparent and independent manner and support to conduct joint studies.

Scientfic Quality Management

ApHER has conducted several register based studies in accordance with the ENCePP code of conduct. We participate in the development of new standards for pharmacoepidemiological research and continuously adjust our processes to reflect any change in the regulatory & academic environment

ApEHR operates within the framework of the Nordic transparency & anti-corruption legislation. These include the guidance issued by the Nordic governments in relation to interactions with civil servants, public employees and the dedicated transparency guidance for medical doctors (including those advising public-sector officials or making decisions related to treatments on patients).

In all our research contracts, ApHER ensures execution compliant with transparency regulations, Good Pharmacovigilance Practice, Anti-Bribery/ Anti-Corruption requirements from Sponsors/ Clients and other parties as applicable for a given study.

ApHER enters into contracts with sponsors and scientists (including physicians) in compliance with these legislations, when conducting observational research. Regardless if the research is a safety commitment invoked by regulatory authorities or proposed by a manufacturer itself.

ApHER is committed to results reporting and a publication processes in accordance with the International Committee for Medical Journal Editors (ICMJE).

Quality focus across research projects

We conduct our research in alignment with applicable regulatory frameworks. Our commitment to provide sound and reliable results is consistent across all projects.

  • ENCePP Coordinating study entity – Please visit the ENCePP study database for a full list of studies conducted by ApHER

  • PASS – Facilitating the conduct of high quality, independent post-authorisation studies (PAS) through clinical and national health registers

  • Governance principles – Developing and maintaining methodological standards and governance principles for pharmacovigilance & pharmacoepidemiology

  • ApEHR is a partner to the ENCePP Network and authorized as research institution by Statistics Denmark and the National Danish Data Agency.

  • ApEHR has a quality management system to ensure that activities and work carried out in the company is done to a high level of quality and ethics and according to state of the art practices for QMS

  • Our quality management system is a collection of business processes reflecting our organizational structure, procedures and resources required to work against external policies and customer needs

  • ApEHR operates in compliance with national and international regulatory requirements