Drug Safety Navigator (DSN) as a contract research organization (CRO) that, on behalf of our customers, collects and processes data regarding adverse events related to our customers marketed or investigational products as part of their regulatory compliance requirements to governmental regulatory agencies such as the European Medicine Agency (EMA) and the Food and Drug Administration (FDA).
Regarding serious adverse event reports from sites participating in clinical trials in the United States of America (USA), Canada and the European Union (EU): DSN, as a CRO, has no direct relationship with medical research subjects participating in a clinical trial and as such does not directly collect patient data or maintain the original source of this data. Regarding adverse event reports for marketed products from the EU, DSN does not directly collect that information and the data we receive does not contain identifiable consumer information. Therefore, patient or consumer data DSN receives does not include any identifiable information and thus is not entered or maintained in our database.
If DSN receives clinical investigator or healthcare professional data as part of an adverse event report, DSN shall enter it and maintain the information in our database. DSN does not transmit that data to our customers or to regulatory agencies or to any other third parties. If a regulatory agency requests information related to a clinical investigator or a healthcare professional’s data, as part of their regulatory oversight or due to public health issues, DSN would provide name and contact information as required. DSN would not provide that information to any third party and since we are not the original source or collector of the information, it is not foreseeable that there would be a need to provide that information to a customer for any law suites.
For the Unites States of America and Canada, when DSN collects Personal Information directly from Individuals, on behalf of our customers and related to their marketed products, DSN shall explain the purpose for which it collects this information and how Personal Information will be used. The only third party this information is provided to is the customer if the individual requests or agrees to be contacted so more information can be obtained related to their inquiry or complaint. Otherwise individual data is not transmitted to any third party or to regulatory agencies. If a regulatory agency requests one of our customers to provide information as part of their regulatory oversight or due public health issues, we would provide that information as required. DSN does not provide information to any other third party.
DSN shall, on request, provide an Individual with confirmation regarding whether DSN has processed Personal Information about them. In addition, upon request from an Individual, DSN shall take reasonable steps to correct, amend, or delete their Personal Information that is found to be inaccurate, incomplete or processed in a manner non-compliant with this Policy or the Privacy Shield Principles, except where the burden or expense of providing access would be disproportionate to the risks to that Individual’s privacy, where the rights of persons other than the Individual would be violated or where doing so is otherwise consistent with Privacy Shield Principles.
Unless prohibited by applicable law, DSN reserves the right to charge a reasonable fee to cover costs for providing copies of Personal Information requested by Individuals. DSN, as a CRO, has no direct relationship with medical research subjects participating in a clinical trials and any such Individuals who seek access, or who seek to correct, amend, or delete their inaccurate Personal Information shall be required to direct his or her query to the relevant study Sponsor or investigator who transferred such Personal Information to DSN for processing.
Privacy inquiries can be sent to
In the context of an onward transfer, a Privacy Shield organization has responsibility for the processing of personal information it receives under the Privacy Shield and subsequently transfers to a third party acting as an agent on its behalf. The Privacy Shield organization shall remain liable under the Principles if its agent processes such personal information in a manner inconsistent with the Principles, unless the organization proves that it is not responsible for the event giving rise to the damage.
DSN has certified as part of EU U.S. Privacy Shield Framework. If any request remains unresolved, Individuals may have a right to invoke binding arbitration under Privacy Shield. The Federal Trade Commission has jurisdiction over DSN' compliance with the Privacy Shield. For further information about Privacy Shield visit https://www.privacyshield.gov.