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Home > Clinical Trial Transparency and Data Sharing > Chiesi Clinical Trial Data Request Portal

Autorizzo al trattamento dei miei dati personali
ai sensi del D.L. 30 giugno 2003 n. 196
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Chiesi Clinical Trial Data Request Portal

Sharing Clinical Trial Data with Qualified Researchers

Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR of Chiesi Farmaceutici S.p.A.-sponsored interventional clinical trials in patients for medicines and indications approved by EMA and/or FDA after 1st January 2015.

Chiesi provides access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.

Fundamental conditions for providing the requested clinical trial data are that qualified Researchers agree to sign a Data Sharing Agreement, to use the data only for non-commercial purposes and to seek publication of their research results.

Nevertheless, the access to clinical trial data is not be granted if any of the following apply:

  • There is a reasonable likelihood that individual patients could be re-identified: for example, clinical trials of rare diseases, single-centre clinical trials, or clinical trials with a very small number of subjects (< 50 subjects);
  • The external research has the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling;
  • There are substantial practical and/or technical constraints to provide data access;
  • There are contractual or legal or patients’ informed consent provisions that prohibit the transfer of clinical trial data to third parties;
  • There is a potential conflict of interest or an actual or potential competitive risk;
  • Lack of necessary documentation related to the request.
Clinical Trial Data Request Process