{"id":13,"date":"2015-01-23T14:42:47","date_gmt":"2015-01-23T14:42:47","guid":{"rendered":"http:\/\/beasleypharmabio.com\/?page_id=13"},"modified":"2016-02-04T19:36:53","modified_gmt":"2016-02-04T19:36:53","slug":"services","status":"publish","type":"page","link":"https:\/\/beasleypharmabio.com\/?page_id=13","title":{"rendered":"Services and Areas of Expertise"},"content":{"rendered":"
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Dr. Beasley\u2019s combined medical and computer science background, along with his training in basic statistical analyses methods provides him with the ability to effectively communicate with and coordinate the activities of medical experts, data management scientists, and statisticians in the design, execution, analysis, interpretation of results,\u00a0and reporting of complex studies with novel endpoints. His experience with large sets of safety\u00a0data\u00a0from complex development programs makes him well suited to the sensitive review of such safety data with an eye toward noting matters requiring focused, in-depth analyses.\u00a0 He\u00a0can work well\u00a0with the technical expert teams necessary for such\u00a0activities and is\u00a0well suited for interpreting the results of such work.<\/p>\n\n\t\t<\/div> \n\t<\/div>

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Key areas of consultation<\/h2>\n\n\t\t<\/div> \n\t<\/div>
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Planning or Authorship of Reports and Manuscripts<\/h3>

Consultation on the planning of\u00a0or\u00a0primary authorship of\u00a0regulatory reports of\u00a0individual studies, integrated analyses, and post-hoc analyses for topics of special interest across\u00a0multiple therapeutic areas as well as academic manuscripts\u00a0in neuropsychopharmacology.<\/p>\n<\/div><\/div>\n\t<\/div> \n\n\t

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Study \/ Development Program Design<\/h3>

Consultation on individual study and\/or development program design in neuropsychopharmacology. This service can include collaboration with your statisticians \/ statistical consultants on the design of the Statistical Analysis Plan; specific analyses; tables, listings, and figures; and the development and authoring of regulatory reports for individual studies and\/or integrated development program results.<\/p>\n<\/div><\/div>\n\t<\/div> \n\n\t

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Consultation on Topics of Special Interest<\/h3>

Consultation on topics of special interest regarding the safety of a compound in development or an approved drug. This can include review of existing data or consultation on analyses designed to explore the specific topic of interest across multiple therapeutic areas.<\/p>\n<\/div><\/div>\n\t<\/div> \n<\/div>

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Analysis<\/h3>

Consultation on methods for analyses of various safety data.\u00a0 Assistance with development and writing of the Statistical Analysis Plan for Safety and \/ or Efficacy for regulatory submissions.<\/p>\n<\/div><\/div>\n\t<\/div> \n\n\t

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Data review<\/h3>

Review of efficacy and\/or safety data for a study and\/or development program with regard to estimation of likelihood of technical success in development across multiple therapeutic areas.<\/p>\n<\/div><\/div>\n\t<\/div> \n\n\t

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Product Liability<\/h3>

Consultation on product liability matters related to safety.<\/p>\n<\/div><\/div>\n\t<\/div> \n<\/div>

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Assistance in Preparation for Regulatory Advisory Committee Documents and Presentations<\/h3>

Review of Integrated Summary Documents (efficacy and safety) as well as summaries for Regulatory Advisory Committees in order to highlight areas of potential concern to regulators and \/ or Advisory Committee members and consultation on potential additional analyses with existing data that are\u00a0intended to potentially mitigate such concerns.<\/p>\n<\/div><\/div>\n\t<\/div> \n\n\t

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\n\n\t<\/div> \n<\/div>\n","protected":false},"excerpt":{"rendered":"Dr. Beasley\u2019s combined medical and computer science background, along with his training in basic statistical analyses methods provides him with the ability to effectively communicate with and coordinate the activities of medical experts, data management scientists, and statisticians in the design, execution, analysis, interpretation of results,\u00a0and reporting of complex studies with novel endpoints. His experience [...]","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/beasleypharmabio.com\/index.php?rest_route=\/wp\/v2\/pages\/13"}],"collection":[{"href":"https:\/\/beasleypharmabio.com\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/beasleypharmabio.com\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/beasleypharmabio.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/beasleypharmabio.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=13"}],"version-history":[{"count":37,"href":"https:\/\/beasleypharmabio.com\/index.php?rest_route=\/wp\/v2\/pages\/13\/revisions"}],"predecessor-version":[{"id":293,"href":"https:\/\/beasleypharmabio.com\/index.php?rest_route=\/wp\/v2\/pages\/13\/revisions\/293"}],"wp:attachment":[{"href":"https:\/\/beasleypharmabio.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=13"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}