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This whitepaper discusses the importance of observational research and patient registries in evidence generation. The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes. These often conflicting perspectives require access to a portfolio of interventional and observational research designs sub-serving different objectives … Increasingly central is the inclusion of observational studies, including registries, which provide insights missing from traditional nterventional studies encountered in the course of drug development.

Every trial starts with a budget, and a clinical trial study start-up process that can be fraught with delays. From contract negotiations, to managing a trial for a sponsor, to streamlining study start-up process, this eBook seeks to instruct others on best practices.

It is critical that partners in clinical research develop systems to maximize the potential of big data while protecting the confidentiality of patient information, to further biomedical research, continued the statement, according to a statement from the European Federation of Pharmaceutical Industries and Associations.

 ClinicalTrials.gov is a federally mandated database with a large and growing, number of required data fields.  Organizations are required to report any study being conducted under FDA auspices.  One of the mandated reporting fields is the date that the FDA receives notification of a clinical trial’s initiation, with less than 3% of the studies in the database missing that information.