cost calculator for clinical trials [beta version]

Compare the cost of using Mitra® Volumetric Absorptive Microsampling Technology (VAMS™) with that of conventional wet blood or plasma for the collection of samples for the determination of circulating concentrations of pharmaceuticals and biomarkers in drug development clinical trials.

For single site first administration to human studies (Phase I), blood and plasma samples are normally sent directly to the bioanalytical laboratory on a regular basis. However, for most multi-site studies (Phase II and III) samples are routinely sent from the various sites to a central laboratory where they are stored until the bioanalytical laboratory requires them for analysis. If your Phase I study has more than one study centre, or uses a central laboratory for the accumulation of samples prior to shipping to the bioanalytical laboratory, you may instead want to use the Phase II or Phase III models.

Select a phase to begin calculating. Note that you can use the calculators multiple times to model several study designs in different phases.

comparison of dried blood microsample collection to conventional plasma sampling

Please complete the entries for the number of shipments as indicated.

The prepopulated values can be changed by the user where indicated.

phase ISingle Site Study

Sample Numbers and Shipments

Samples per shipment ?

phase IIMulti-Site Study

Sample Numbers and Shipments

Samples per shipment from Central Lab

phase IIIMulti-Site Study

Sample Numbers and Shipments

Samples per shipment from Central Lab

Consumables

Assumes that costs for consumables for sample collection, such as alcoholic wipe, lancet, needle / cannula, etc, are the same.

Plasma Costs Cost per Unit currency in USD Total
$
$
$
$
$
Consumable Total Plasma
$ USD
Mitra Costs Cost per Unit currency in USD Total
$
$
$
Consumable Total Mitra
$ USD

Shipping

The cost of a sample shipment is normally the same regardless of the number of samples, as it is based on the cost of shipping a fixed sized container which does not vary with the number of samples. However, shipment costs do vary for domestic versus international and for frozen versus ambient temperature.

Plasma Costs Cost per Shipment currency in USD Total
$
$
Shipping Total Plasma
$ USD
Mitra Costs Cost per Shipment currency in USD Total
$
$
Shipping Total Mitra
$ USD

Storage

Assumes standard protocol involving -20 °C freezer storage for wet samples. (Mitra samples are stored at ambient room temperature provided that stability has been demonstrated.)

Plasma Costs
$
$
Storage Total Plasma
$ USD
Mitra Costs
Storage Capacity n/a
Elec. per month @ -20°C ($) n/a
Depreciation per month ($) n/a
Storage Time (months) 0
Storage Total Mitra
$0.00 USD

Disposal

Assumes biohazard transport, handling, and disposal.

Plasma Costs Costs currency in USD
$
$
$
$
$
Disposal Total Plasma
$ USD
Mitra Costs Costs currency in USD
$
$
$
Disposal Total Mitra
$ USD

Analysis

The only difference in the process between the analysis of plasma and Mitra samples is the use of tips and the volume of control matrix for calibration standards, quality control samples, and blanks. The extraction process is comparable, so the number of tubes and solvent costs for all formats are similar and therefore are not calculated for this part of the process.

Plasma Costs
Samples per run
Runs per study
Total No Runs / Study ?
 
 
 
Total Number Cals, QCs, Blanks per Study
Total Matrix Volume (mL)
Cost of Matrix ($) $
Analysis Total Plasma
$ USD
Mitra Costs
Samples per run
Runs per study
Total No Runs / Study ?
Total Number of Tips per Study
Cost of Mitra Tips ($) $
Total Number Cals, QCs, Blanks per Study
Total Matrix Volume (mL)
Cost of Matrix ($) $
Analysis Total Mitra
$ USD

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This calculator was created in association with Dr. Neil Spooner of Spooner Bioanalytical Solutions, Ltd.

This calculator is designed to be an informational and educational tool only. We accept no responsibility regarding the accuracy of any estimates generated by using this calculator, or for any decisions that result from its use.