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User Roles & Responsibilities

System overview — two distinct roles collaborate through the workflow

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INVESTIGATOR

Site Investigator

The site-level participant who receives the protocol from the Sponsor, performs the coverage analysis, and negotiates the budget to reflect site-specific costs and requirements.

Log in with investigator credentials to access the assigned site
View all protocols that have been shared by the Sponsor
Initiate and auto-generate the coverage analysis for a protocol
Customize payer assignments (Sponsor / Insurance / No Payer) per procedure and visit
Share the completed coverage analysis back to the Sponsor
Receive and review the Sponsor's draft budget
Create a site-specific budget (cloned from the Sponsor budget)
Compare site budget vs. Sponsor budget side-by-side
Take actions on each line item: Agree or Raise a Request
Generate and download the final agreed budget document

Investigator Steps in this Guide

2.1 Access → 2.2 Analysis → 2.3 Customize → Step 4 Budget

🔄 Complete Workflow Overview — Step by Step

Step	Role	Action	Outcome
1.1	👔 Sponsor	Register & log in (OTP)	Sponsor account activated
1.2–1.3	👔 Sponsor	Create protocol + upload procedures	Protocol document ready
1.4	👔 Sponsor	Share protocol with sites	Site Investigators receive invitation
2.1	👨‍🔬 Investigator	Log in & view shared protocol	Protocol accessible to site
2.2	👨‍🔬 Investigator	Create coverage analysis	Auto-generated procedures & visits table
2.3	👨‍🔬 Investigator	Customize & share analysis	Payer assignments sent to Sponsor
3	👔 Sponsor	Review analysis, create & share draft budget	Draft budget delivered to site
4	👨‍🔬 Investigator	Create site budget, compare, take action	Budget actions submitted to Sponsor
5	👔 Sponsor	Review actions, negotiate line items	All items agreed upon
6	✅ Both	Generate & download final budget	Final budget ready for implementation

1.1

Sponsor Account Setup

Step 1 of 6

1

User Registration Process

1 Sign up as a Sponsor user.
2 The signup process is based on data privacy. After agreeing to terms, you may proceed with signup.
3 This is an OTP-based signup process — a one-time passcode will be sent to your registered email/phone.
4 After signup is complete, log in as a Sponsor.

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Important Security Note

The signup process is OTP-based for enhanced security. Ensure you have access to the email/phone number provided during registration for verification purposes.

STEP 1.1 Sponsor signup & OTP verification screen

1.2

Protocol Creation

Steps 1.2 – 1.3

1

Creating a New Protocol

1 From the Sponsor home page, click "+Create New Protocol".

STEP 1.1 Create New Protocol

2 The Create Sponsor Study form will appear.
3 Fill in all required fields — especially Country and Condition.

STEP 1.2 Create Sponsor Study form — fill all required fields

2

Planned Visit Configuration

Choose one of the following three options for visit planning:

OPTION 1

Direct Total Count

Directly enter the total planned visit count.

STEP 1.2 Planned visit configuration — option 1

OPTION 2

Detailed Visit Planning

Enter visits per cycle. The system automatically calculates the total visits planned.

STEP 1.2 Planned visit configuration — option 2

OPTION 3

Upload Excel Sheet

Upload a visit-planned Excel sheet. Download the provided template as a reference — only the template format is accepted.

STEP 1.2 Planned visit configuration — option 3

3

Procedure Upload

1 Upload the procedure Excel sheet using the same format as the visit planned file.
2 Only the approved template format is supported — other formats will not match correctly.

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Alternative: PDF Upload with AI

You may upload a PDF of the protocol document. The AI feature will automatically extract the required procedures from the PDF.

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Critical Compatibility Note

The Excel sheet used for visit planning must match the procedures in the PDF. Mismatches will prevent downstream processes from functioning correctly.

STEP 1.2 Procedure Excel upload & PDF AI extraction screen

4

1.3 — After Creating the Protocol Document

1 After submitting the protocol form, you will be redirected to the Protocol Detail Page.
2 Review the details of the protocol you just created.

STEP 1.3 Protocol detail page after creation

1.4

Share Protocol Documents

Step 1.4

1

Sharing Process

1 Click the Share button on the Protocol Detail Page.

STEP 1.4 Share

2 Three options will be presented:

OPTION A

Available Sites

Sites already registered in the system. You can share with multiple sites simultaneously.

STEP 1.4 Share protocol — available sites

OPTION B — AI

Recommended Sites

1 AI-based site recommendations. Select multiple sites and multiple locations per site.
2 When you navigate to the Recommended Sites section, you will see a list of suggested sites. Each site may include one or multiple locations, and each location may have one or more associated contact persons.

STEP 1.4 Share protocol — recommended sites

3 If contact details are not available for a selected location, you can manually add the required contact information by referring to sources such as Google, the site's official website, or ClinicalTrials.gov.
4 You can then select one or more sites, along with their respective locations, and assign at least one contact person for each.
5 Once you click Submit, an invitation email will be sent to the selected site(s) for review and potential participation.
6 If the selected site already exists in our system, the protocol document will be automatically shared with that site. The site will receive an email notification informing them that the protocol has been shared for their review.

STEP 1.4 Share protocol — recommended sites

OPTION C

Create New Site

Create a new site entry directly from the sharing screen.

STEP 1.4 Share protocol — create new site

3 After sharing, you will be returned to the Sponsor home page.

2.1

Site Investigator Login & Protocol Access

👨‍🔬 InvestigatorStep 2.1

1

Access Assigned Protocols

1 Log in with your investigator credentials to access your assigned site.
2 Click "View All Protocols".

STEP 2.1 Investigator view — list of all shared protocols

3 All shared protocols will be listed.
4 Click "View Details & Start Coverage" for the relevant protocol.

STEP 2.1 Investigator view — view details of a protocol

2.2

Create Coverage Analysis

👨‍🔬 InvestigatorStep 2.2

1

Automatic Coverage Analysis Creation

1 Click "Create Coverage Analysis".

STEP 2.2 Create Coverage Analysis

2 The system automatically generates a table of procedures and planned visits — based on total visit count, detailed visit plan, or the uploaded Excel sheet.

STEP 2.2 Create Coverage Analysis

3 By default, the sponsor is set as the payer for all procedures.

STEP 2.2 Auto-generated coverage analysis — procedures & visits table

2.3

Customize Coverage Analysis

👨‍🔬 InvestigatorStep 2.3

1

Edit & Customize

1 Edit the coverage analysis according to the validated document.
2 For each procedure and visit combination, designate the payer: Sponsor, Insurance, or No Payer.
3 Once customization is complete, share the coverage analysis back to the Sponsor.

Customize Coverage Analysis — Payer Assignment

STEP 2.3 Customizing payer per procedure & visit, then sharing to sponsor

3

Sponsor Budget Workflow

Step 3

1

View Shared Coverage Analysis

1 Log in as Sponsor and click "Shared Sites".

2 All sites shared for this protocol document are listed.
3 Click "View Shared Coverage Analysis".

STEP 3 Sponsor shared sites listing with coverage analysis access

4 Click "View Budget Templates / Create Custom Budget".

Sponsor Shared Sites & Coverage Analysis View

STEP 3 Sponsor shared sites listing with coverage analysis access

2

Budget Creation Options

OPTION A — Custom

Create Custom Budget

Manually fill in each and every budget line item from scratch.

STEP 3.2 Budget creation — custom manual entry

OPTION B — Template

Template Budget

Click "Create Customized Budget" from a template. The system generates the budget automatically.

STEP 3.2 Budget creation — Template auto-generation

3

Budget Review & Draft Creation

1 Review each and every budget line item carefully.
2 Customize prices according to your requirements.
3 Create the Draft Budget.

STEP 3.3 Sponsor reviewing & customizing budget line items before sharing

4 Share the draft budget with the Site Investigator.

Share the draft budget with the Site Investigator.

STEP 3.4 Share draft budget with Site Investigator

4

Site Investigator Budget Workflow

👨‍🔬 InvestigatorStep 4

1

Create Site Budget

1 Log in as Investigator and click "View All Protocols".
2 Review the current status of the site budget and sponsor budget.
3 Click "Create Site Budget" — this clones the sponsor budget as the starting point.
4 Customize line items to reflect site-specific pricing.

STEP 4.1 Creating site budget — cloned from sponsor budget with editable pricing

2

View site budget & Compare it with Sponsor Budget

1 Click "View Site Budget".

STEP 4.2 View Site Budget link

2 Click the "Compare Budget" button to see a side-by-side comparison of site budget vs. sponsor budget prices.

STEP 4.2 Side-by-side budget comparison — site price vs. sponsor price

3

Take Actions on Budget Items

1 For each line item, choose to Agree with the price or Raise a Request for a different amount.
2 Available buttons depend on price differences and whether an item is negotiable.
3 After providing actions for all items, Submit all actions.

Budget Item Actions — Agree or Raise Request

STEP 4.3 Per-line-item action buttons — Agree / Raise Request

5

Sponsor Budget Review & Negotiation

Step 5

1

View Site Actions

1 Log in as Sponsor and click "Shared Sites".
2 Click "View Shared Budget".
3 Click "View Budget Actions" to review all actions taken by the Site Investigator.

Sponsor View Budget Actions from Investigator

STEP 5.1 Sponsor reviewing investigator's budget action responses

2

Sponsor Response Actions

1 For each line item, the Sponsor may: Agree, Raise Request, or Reject.
2 Provide a response for every line item and then Submit all actions.

STEP 5.2 Sponsor per-line-item response — Agree / Raise Request / Reject

3

Negotiation Process

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Iterative Negotiation

This process continues until both the Sponsor and the Site Investigator have agreed on a price for every line item. Both parties must agree on each item before the final budget can be generated.

Iterative negotiation process — both parties must agree on each line item

6

Final Budget Generation

✅ Both RolesStep 6

1

Generate & Download Final Budget

SITE INVESTIGATOR

Generate Final Budget

Click "Generate Final Budget" to produce the agreed-upon budget document.

Site Investigator Final Budget Generation

Generate Final Budget for Site Investigator

SPONSOR

View Final Budget

Click "View Final Budget" to access the finalized budget.

View Final Budget for Sponsor

✓ The final budget can be downloaded by both parties for record-keeping and implementation.

STEP 6 Final budget view — ready to download for both parties

Coverage Analysis & Budgeting System