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Sheet1
| Attachment A: Pricing Worksheet for Sample Task Order | | |
| Sample Task Order - Bioequivalence of generic oral products coadministration with acid-reducing agent in Healthy Volunteers | Performance Duration: | 3 years |
Please provide the breakdown of the cost separately - own format can be used. When applicable, please include the plan and reports for each item.
| Anticipated Labor Categories (Fully Burdended Labor Rates) | Unit cost | # of unit | Total |
| Project Manager | | | |
| Contract Manager | | | |
| Total | | | |
| Per Study Price ($) | # | Total |
| Study document preparation (protocol/informed consent form/SDs/eCRFs) | | | |
| Regulatory document preparation (TMF) | | | |
| Institutional Review Board (IRB) fees and other fees | | | |
| Lab set-up/transfer Fees | | | |
| Study plans (Recruitment, TMF, RM, DM, etc; list in the breakdown) | | | |
| Total | | | |
| Per Subject Price ($) | # |
| Informed consent process | | |
| Standard screening cost (Medical history, Prior/concomitant meds, physical exam, etc) | | |
| Vital signs | | |
| Standard safety laboratory tests (list tests or include details in the breakdown) | | |
| Misc (list in the breakdown) | | |
| Total for Screening | | |
| In-house day/overnight stay | | |
| Meals (1 day) | | |
| Vital signs | | |
| Standard safety laboratory tests (list tests or include details in the breakdown) | | |
| Outpatient visit | | |
| Study agent preparation, dispensing & administration - oral | | |
| Blood draw (per time point) | | |
| Monitoring including Adverse event assessment | | |
| Sample processing and storage (per sample) | | |
| Misc (list in the breakdown) | | |
| Total for Treatment | | |
| EXAMPLE PASS THROUGH PRICES ($) | Per Subject Price ($) | # |
| Stipend - Screening | | |
| Stipend per visit - Outpatient blood draw | | |
| Stipend per visit/period - in-house | | |
| Stipend (Stand-by) | | |
| Total | | |
| Total for per subject cost | | |
| Per study Price ($) | # |
| Database cost per month | | |
| DM activities (list items in the breakdown) | | |
| Total | | |
| Price ($) | # |
| Bioanalytical assay method development & validation - small molecules, 2 analytes | | |
| Bioanalytical per sample - 2 analytes | | |
| Bioanalytical per sample - 2 analytes for Incurred Sample Reanalysis | | |
| Bioanalytical plan and report | | |
| Total | | |
| Price ($) | # |
| Randomization | | |
| Listings and Reports including TLFs | | |
| Biostatistical activities (List activities) | | |
| Total | | |
| Per Study Price ($) | # |
| Supplies | | |
| Document retention (15 years) | | |
Total
| Price ($) | # |
| Progress reports | | |
| Clinical study report | | |
| Final presentation | | |
| Total | | |
