All work

Case study 02 · Workflow automation · Compassionate use

Compassionate Use Workflow

Single-patient protocols have no EDC or RTSM behind them and usually run on paper. This validated system takes each dose from site weight entry to approved, dispensed kits, with every step recorded.

Role
Designed, built and owns the system
Built with
Microsoft Forms, Power Apps, Power Automate, SharePoint and Outlook
Setting
Crossbow Therapeutics, compassionate use program
Status
Validated and live in production · Recognized internally

The tool

Interactive · click through a request · illustrative data

Compassionate Use · Dose requests
Request CU-0317 · Patient 212-007 · Cycle 2 Day 8Pending approval

Request status · click a step

Try a different weight

Audit trail

  • 16:08 · Weight 75 kg submitted by site pharmacist
  • 16:21 · 10 mg/kg entered, 760.00 mg sent for approval

Approver view · Outlook and Power Apps

Dose approval required

Pending
Patient · visit
212-007 · Cycle 2 Day 8 · SC
Weight check
-1.3% · within 10%, dose on baseline
Calculation
76 kg × 10 mg/kg = 760.00 mg
Calculated dose
760.00 mg

The problem

A patient’s dose shouldn’t depend on paper forms and manual math

Compassionate use requests are single-patient protocols, so there is no EDC or RTSM to lean on. Most programs run them on paper forms, email and spreadsheets. Yet each dose still needs a current patient weight from the site, a calculated dose, sign-off from medical and executive approvers, and the right kits released to the right site for every visit. Every handoff is a chance for delay or error.

Because it touches patient dosing, the system also had to stand up to inspection: controlled inputs, recorded approvals and documented validation.

What I built

Four phases, one record

  1. 01

    Site weight entry

    A controlled form for sites to submit patient weight, creating one record per dose request.

  2. 02

    Dose calculation

    A Power Apps screen applies the weight-based dosing rules, checks weight change against baseline, and handles each route of administration separately.

  3. 03

    Approval routing

    Formatted approval notifications to named medical and executive approvers, who can approve or send a request back for edits. Each decision is written to the record.

  4. 04

    Kit dispensing

    An approved dose assigns the right kits from live inventory, then notifies the site.

Results

What changed

  • Site weight entry to approved dose and assigned kits in as little as 5 minutes
  • Every weight, calculation and approval recorded in validated SharePoint lists
  • Paper forms replaced end to end, from site entry to dispensing
  • Built to scale, and can be cloned for each new study

Next case study

Clinical Operations & Supply Command Center