Anova Enterprises, Inc. (Anova), a leading technology-enabled Clinical Research Organization (CRO) focused on accelerating and reducing the cost of clinical development, today announced the launch of ...

A trial master file is a collection of important documents pertaining to a study, clinical trial or other form of research. Periodically, the trial master file must undergo audits to ensure the ...

The SD File format offers benefits for KASA and cheminformatics to support regulatory submissions. Drug Master File (DMF) holders provide a hazard assessment for impurity classification to comply with ...

The US Food and Drug Administration (FDA) is exploring the use of model master files (MMFs) to enable sponsors to use the same modeling approach to support different generic drug development programs, ...

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial ...

A collection of transaction records. The data in transaction files is used to update the master files, which contain the data about the subjects of the organization (customers, employees, vendors, etc ...

FDA has developed a new set of requirements for documenting the safety of dietary supplement ingredients. Manufacturers are able to market products with new ingredients without preapproval as long as ...

The administration of the non-transactional data in an organization, such as customers, vendors, employees and products. Such data is contained in "master files," although the term master file has ...