Biostatistics. [***] will initially be responsible for biostatistics matters with respect to the Shared Products including the performance of the biostatistics activities set forth in the Global Development Plan in accordance with the Global Development Plan. [***] upon [***], as determined by the JDC [***]
Biostatistics. Provide shells of tables and listings • Raw data • Summary statistics • Inferential statistics Statistical Analysis Plan • Provide template (including table of contents of statistical appendices) • Preparation • Review • Approval of final version MASTER CLINICAL SERVICES AGREEMENT FORENAP PHARMA – TARGACEPT III – After Study activities SPONSOR INVESTIGATOR CENTER (Forenap-pharma)
Biostatistics. Sponsor will be responsible for the Biostatistical aspects of this trial. Medical Writing TKL will assign a lead medical writer to write all SAE narratives that occur during the study.
Biostatistics. 76) Biostatistical support to the study will be provided by CNS’s Biostatistics team based in Australia. CNS Biostatistician will join the initial team kick-off meeting with the PM and lnCannex to confirm service expectations and timelines.
Biostatistics o Randomization/ Kit list/ Interactive Response Technologies Review List 2.00 6,024.00 12,048.00 o Data Management Specifications Protocol 1.00 6,574.55 6,574.55 o Statistical Analysis Plan & Mock Shells Plan 1.00 17,893.58 17,893.58 o Study Data Tabulation Model (SDTM) Datasets Dataset 25.00 2,688.39 67,209.84 o Analysis Datasets Dataset 15.00 3,353.40 50,300.93 o Define.xml and Data Reviewers Guide for SDTM, Annotated CRF Specification 5.00 5,084.93 25,424.65 o Deliver Final Database & Table, Figures & Listings Delivery 1.00 7,643.93 7,643.93 Final Unique Study Tables Unique Table 25.00 1,544.01 38,600.23 Final Repeat Study Tables Repeat Table 50.00 608.63 30,431.36 Final Unique Study Listings Unique Listing 25.00 944.60 23,614.97 Final Unique Study Figures Unique Figure 10.00 2,833.80 28,337.97 Final Repeat Study Figures Repeat Figure 10.00 936.55 9,365.46 o Statistical Input to Clinical Study Report (CSR) CSR 1.00 6,425.06 6,425.06 o Delivery Dry Run Database & Table, Figures & Listings Delivery 1.00 15,315.15 15,315.15 Sub-Total Biostatistics 339,185.68 Medical Writing o Model Inform Consent Form(s) (ICF(s)) ICF(s) 3.00 8,204.00 24,612.00 Sub-Total Medical Writing 24,612.00 Clinical Assessment Technologies o Scale Identification and Acquisition Scale 6.00 1,029.00 6,174.00 o Creation of Source Documents Language* Scale 12.00 429.63 5,155.50 o Rater Training Plan Plan 1.00 2,805.00 2,805.00 o Rater Experience Verification Rater 43.00 96.75 4,160.25 o Rater Training and Certification Rater 34.00 182.50 6,205.00 Page 42 of 47 Service Agreement Budget Services Unit # Units Unit Cost USD Total Cost USD o Applied Skill Assessment (ASA) not at Investigator Meeting ASA*Rater 34.00 275.88 9,379.75 o Didactic Presentation Presentation 1.00 1,438.38 1,438.38 o Web Portal Portal 1.00 6,043.10 6,043.10 o Data Surveillance Plan Plan 1.00 13,985.50 13,985.50 o Set-up of Clinical Assessment Technologies EDC Data Monitoring System System 1.00 9,837.50 9,837.50 o Clinical Assessment Technologies Data Management Reports Month 24.00 398.57 9,565.71 o Electronic Data Capture (EDC) Flag Clinical Review Visit 384.00 215.41 82,715.84 o Collection & Review of Source Documents Visit * Scale 244.00 151.25 36,905.00 o Clinical Assessment Start-up & Planning Month 5.00 1,798.25 8,991.25 o Clinical Assessment Maintenance & Reporting Month 24.00 938.13 22,515.01 o Clinical Assessment Technologies Virtual Training Session WebEx 2.00 6,306.00 12,612.00 Sub-Total Clinical Assessment T...
Biostatistics. Protocol V4 Final Analysis: Number of Tables - Unique* *** Number of Tables - Repeat* *** Number of Listings - Unique* *** Number of Listings - Repeat* *** Number of Figures - Unique* *** Number of Figures - Repeat* *** Number of Interim Analysis: *** Number of Tables - Repeat *** Number of Listings - Repeat *** Number of Figures - Repeat *** Number of DSMBs: *** Number of Tables - Repeat *** Number of Listings - Repeat *** Number of Elapsed Weeks for Production of TLFs, After Corresponding Data Transfer or Lock *** * The unique and repeat TLF counts listed above are for the Final Analysis. All TLFs included in the Interim Analysis and DSMBs are assumed to be repeat TLFs of the Final Analysis.
Biostatistics. A Manual of statistical methods for use in Health, Nutrition and Anthropology K Xxxxxxxxxx Xxx XXXXXX 2nd 2
Biostatistics. 2.2.13 Systems biology 2.2.14 Genetic diseases
Biostatistics. Taking data to analysis requires the right partner with the correct knowledge and experience. Our highly qualified biostatistics team will partner with you and your team to plan and design the analysis which best meets your study’s needs. Each study is assigned a highly qualified biostatistician who will consult on all statistical aspects of your study. This includes helping contribute to the protocol including sample size calculations if needed as well as development of the randomization plan. A statistical analysis plan (SAP) will be created using the Xxxxxxxxx standard template, outlining the exact analysis needed for your particular study and design and will include mock table, listing and figure (TLF) shells to ensure final reporting meets your needs. Our statistical programming team is very well versed in CDISC standards and will develop the analysis datasets to XXxX standards. They will provide you with a fully annotated version of the Pinnacle21 (aka OpenCDISC) report outlining any discrepancies from the standard. They will also create the TLFs to match the shells outlined in the SAP. In collaboration with data management, the Pharmacokineticists, and you, our biostatistics team offers a data review meeting (DRM) immediately after delivery of draft TLFs to provide topline review of data results and interpretation. This review allows you a forum to discuss the results of your study with our team and experts to ensure the study needs are complete prior to delivery of the draft clinical study report (CSR). Upon final approval of the TLFs our statistician collaborates with the study’s medical writer to draft the statistical interpretation portion of the CSR. Electronic submission (eSUB) needs are becoming more prevalent in our industry and Xxxxxxxxx Clinical has the knowledge and expertise to support all of your needs. The CDISC eSUB standard is referred to as the case report tabulation (CRT). Our biostatistics team will create all components of the CRT, including the SDTM annotated CRF (aCRF), define.xml for both SDTM and XXxX as well as the study data reviewer’s guide (sDRG) supporting SDTM and the analysis data reviewer’s guide (aDRG) supporting XXxX. Clinical Pharmacology/Pharmacokinetics (PK) There are multiple and complex considerations that must be contemplated when designing, executing, analyzing, and reporting clinical studies that involve pharmacokinetic evaluations. Our PK team will help the sponsor’s team to find the best solutions for your...
Biostatistics. Units Number of Tables - Unique* †† Number of Tables - Repeat* †† Number of Listings - Unique* †† Number of Listings - Repeat* †† Number of Figures - Unique* †† Number of Figures - Repeat* †† Number of DMCs (15 Tables and 10 Listings) †† Number of Elapsed Weeks for Production of TLFs, After Corresponding Data Transfer or Lock 4 weeks * The unique and repeat TLF counts listed above are for the Final Analysis. All TLFs included in the DMCs are assumed to be repeat TLFs of the Final Analysis.
