BASi® has an outstanding regulatory record. You will be more confident in meeting your targets and having a successful review and audit of your data by working with our experienced scientific team.
All of our facilities are inspected by the U.S Food and Drug Administration (FDA). Unannounced inspections have always resulted in either no findings or have required voluntary actions for correction. Those steps are documented in a form 483. To date, all of BASi®’s responses to 483s have been accepted by the FDA, resulting in no further action.
o Individuals participating in clinical studies with sample analysis conducted at Bioanalytical Systems Inc. contracts should be aware of the following:
o Bioanalytical Systems Inc. study information is provided by study contract to the Pharmaceutical Industry organization that sponsors the study; no routine disclosure of information to third parties is conducted unless the sponsor has identified (e.g. a Central Laboratory) in their contracts
o Bioanalytical Systems Inc. recognizes the rights of individuals participating in the studies to access their personal data, however since Bioanalytical Systems Inc. does not received personal identifiers for the samples (other than accession numbers or similar) we are unable to identify what sample corresponds to what subject, therefore we encourage individuals to contact the sponsor of their study to access their information.
o As indicated above Bioanalytical Systems Inc. does not receive or maintain personal data so we comply by only providing the results of the samples we test to the study sponsor or their contract indicated third parties
o Bioanalytical Systems Inc data is transferred as per Data Transfer Agreements that include the level of security determined by the sponsor appropriate to their studies, therefore e.g. the use of encrypted data transfers and/or password protection reduces Bioanalytical Systems Inc. liability in cases of onward transfers to sponsors or third parties