Solvay Pharmaceuticals conducts clinical trials worldwide to assess the safety and effectiveness of our compounds. Solvay Pharmaceuticals is committed to publicly disclose information on Solvay sponsored clinical trials. We feel that by doing so, we contribute to the transparency of the conduct of clinical trials and provide information that will be beneficial to patients, doctors, and the public.
Clinical Trial Registry
Solvay Pharmaceuticals has registered all Solvay sponsored interventional clinical trials in patients, including phase 1 studies, in a public clinical trial registry starting in July 2005 (ClinicalTrials.gov). Solvay follows industry wide commitments on trial registration as given in the Joint Position Statement on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases, as originally issued by IFPMA, PhRMA, EFPIA, and JPMA in January 2005 and its revision in September 2005.
Solvay discloses all clinical trial information, so-called data elements, as required by the FDA Amendments Act of 2007. Solvay will also register retrospectively any clinical trial for which we will post results in compliance with the different new worldwide legislations. On ClinicalTrials.gov the Solvay Pharmaceuticals sponsored studies can be recognised by Solvay being the information provider. In addition, on ClinicalTrials.gov there are trials registered by development partners and investigators supported by Solvay, but for which Solvay is not the trial sponsor and, therefore, also not indicated as the provider of the trial information.
Clinical Trial Results disclosure
Solvay Pharmaceuticals is committed to also comply with the new U.S. federal legislation (FDA Amendment Act of 2007), the State of Maine legislation and other new laws that will be installed in the future regarding the disclosure of clinical trial results. This means that the results of all clinical trials corresponding to one of these laws are posted in a publicly accessible website such as www.ClinicalTrials.gov or another website defined within the law.
