At data and validation using SASTailored statistical backingWriting specifications

At RPM, we have expert biostatisticians team with specific therapeutic expertise and extensive regulatory knowledge that provides deliverables of high quality for clinical development plan and design, effective analysis and reporting and regulatory support that match our client needs. Our biostatistics experts ensure uncompromised validation and accurate analysis of data with quality control processes to provide flexibility, speed and accuracy with trial reporting.Our biostatistician’s expert team are proactively involved and informed throughout the trial phase. With the years of experience in clinical trials and strong analytical background, we are able to tackle various complex trials to meet our client’s desired expectations.Efficient cost-saving clinical trial designProtocol developmentStatistical consultingSample size calculationsInclusion/exclusion criteriaStudy endpoints developmentRandomization schedule/blinding/unblindingStatistical input in study synopsisStatistical analysis plan (SAP) developmentAdaptive design and analysisPatient profile reportingInput in CRF/eCRF designIntegration of CDISC into entire studyStatistical Analysis and ReportPharmacokinetic and pharmacodynamic analysesRegulatory strategy for biostatisticsRegulatory submissionsFinal Statistical Reports/Clinical Study ReportIntegrated safety and efficacy analyses (ISS/ISE)Data and safety monitoring board (DSMB) outputBlinded/unblinded interim analysisInvestigational new drug (IND) safety updatesData Monitoring Committee (DMC) supportCDISC-compliant datasets (SDTM and AdaM) development and validationFinal data analysisData conversion and validationStatistical analysis of clinical data and validation using SASTailored statistical backingWriting specifications document (SPD)Creation and validation of tables, listings and figures for the Clinical Study Report (CSR) as per standard operating procedures (SOPs) to statistical input to the CSRIndependent quality assurance through external and internal consultingMeta-AnalysisCollaboration with clinical scientists and medical writers to ensure significant analysis of quantitative resultsPublication supportSAS ProgrammingRPM SAS certified clinical programming team have ability to turn inexplicable data into something significant in order to make informed decisions, demonstrate drug efficacy, improvement in patient safety and faster introduction of drugs in the market. Our programming expert team also have detailed knowledge of therapeutic areas and all the phases of clinical trials.Our SAS programming services include:Clinical and statistical programming supportSAS programming compliant to CDISC/CDASH standardsDatabase Specification creationCDISC standards: SDTM and ADaM, annotated CRF, define.xml file implementation and programming for regulatory submissionsGenerating programming specifications for SDTM and ADaM datasetsProgramming and validation of SDTM and ADaM datasets, tables, listings and figuresCustom Report ProgrammingCreation of Case Report Tabulations using CDISC standardsSAS Mapping SpecificationSAS-Macros design, development and validationStatistical Analysis Plan (SAP) and Mock-up ShellsWriting and maintaining specifications and SAS analysis programs based on SAPData Management ListingsSAS Edit Checks programmingData Analysis and Report GenerationStatistical analysis validationCreation of documentation for integrated databasesISS and ISE programming support and quality control for ISR (Integrated Summary Report)Statistical analysis modellingSubject profiles and medical review listing programmingStudy rescue and legacy data requestsRisk based validation, double-independent programmingInterim Analysis supportStatistical Meta-AnalysisAnnual Safety UpdatesData Monitoring Committee (DMC),  Safety Committee  and Endpoint Committee Support


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