Clinical Research Finance

INDEX /

THE OPERATING PROBLEM

Funding is not the same as readiness.

A study can be funded and still stall when coverage, schedule, budget, agreement, system build, and amendments do not resolve against one another.

THE FINANCIAL SEQUENCE

DETERMINATION

Approved basis

SCHEDULE

Timing and events

BILLING GRID

Payer mapping

BUDGET

Cost and gaps

AGREEMENT

Scope and terms

SYSTEM BUILD

Configured record

AMENDMENT

Reconciled change

CONTROL BY DESIGN

Proof belongs beside the work.

CONTROL BY DESIGN

01

WRITTEN RATIONALE

Designations are paired with a documented basis and an approval boundary.

02

CONNECTED ARTIFACTS

Each output is tested against the preceding financial line.

03

CONTROLLED ENVIRONMENT

System access and delivery are defined by the approved engagement.

THE FINANCIAL LEDGER

Six entries. One connected line.

Every entry shows the approved input, accountable work, output, and decision boundary.

FINANCIAL LEDGER

ENTRY

APPROVED INPUT

KARAMATA WORK

OUTPUT

DECISION BOUNDARY

Medicare Coverage Analysis

Approved protocol, schedule, CMS policy, applicable determinations, and organizational policy.

Designate routine-care and sponsor-paid items; document the basis for each designation.

Written coverage analysis and decision rationale.

Client retains policy interpretation and approval.

Billing Grid Review & Build

Approved schedule and coverage designations.

Map visits and procedures to payer responsibility; prepare or rebuild the grid.

CTMS/EHR-ready billing grid.

Client approves configuration and system acceptance.

Sponsor Budget Analysis

Schedule, grid, expected protocol cost, and proposed budget.

Test line items against study requirements and surface negotiation gaps.

Gap analysis and negotiation-ready issue set.

Client retains commercial decisions and approval.

CTA & SOW Review

Protocol, budget, grid, agreement, and SOW.

Surface operational and financial inconsistencies across scope and terms.

Documented issue ledger.

Legal advice and signature remain with client and counsel.

REC Forms & CTMS Study Build

Approved forms, tracker requirements, calendar, and designations.

Configure study records, financial entries, and billing designations.

Engagement-defined system build and validation set.

Client controls access, acceptance, and production release.

Amendment Budget Support

Changed protocol and approved baseline artifacts.

Assess impact across coverage, grid, budget, agreement, and build.

Reconciled change set and open-decision record.

Client retains final approval.

ONE ACCOUNTABLE WORKFLOW

From approved input to reconciled handoff.

WORKFLOW LEDGER

STEP

INPUT

KARAMATA ACTION

OUTPUT

APPROVAL POINT

Scope & Access

Approved engagement scope and source set.

Confirm assumptions, systems, roles, and access boundaries.

Source map and responsibility plan.

Client confirms scope and access.

Assess & Map

Protocol, schedule, and current financial artifacts.

Trace dependencies and identify gaps or contradictions.

Baseline and issue ledger.

Shared disposition of open decisions.

Build & Document

Approved designations and decisions.

Prepare the analysis, grid, budget support, or system entries.

Version-controlled work products.

Client reviews defined approval points.

Test & Align

Draft work products and related artifacts.

Reconcile each output against the preceding line.

Resolved variance record and aligned set.

Shared acceptance of exceptions.

Hand Over

Approved final artifacts.

Deliver, document status, and identify remaining ownership.

Handoff package and open-items record.

Client accepts handoff and retains final authority.

AUTHORITY BY DESIGN

Clear work. Defined authority.

Responsibilities are engagement-specific. Final legal, billing, payer, signature, and release authority remains with the client.

AUTHORITY MATRIX

KARAMATA OWNS

—

Source and dependency mapping

—

Coverage and billing designation work

—

Financial issue analysis

—

Written rationale and decision record

—

Variance flagging and handoff preparation

CLIENT RETAINS

—

Legal advice and contract signature

—

Organizational policy and payer decisions

—

Billing and claim submission

—

Production-system control

—

Final approval and release

SHARED APPROVAL POINT

—

Scope and assumptions

—

Source completeness

—

Issue disposition

—

Configuration or designation acceptance

—

Exceptions, handoff, and open items

SYSTEMS & SECURITY

Controlled access. Documented handoff.

Access, environment, data handling, and handoff are defined for the engagement. KARAMATA does not assume universal system or PHI conditions.

ENGAGEMENT CONTROLS

01

APPROVED ENVIRONMENT

02

ENGAGEMENT-DEFINED ACCESS

03

RECONCILED EXIT AND OPEN-ITEMS RECORD

DATA SECURITY →

WHEN TO ENGAGE

You’ll recognize the moment.

Bring the break in the financial line—not an audience label or a preselected delivery model.

ENGAGEMENT CUES

A protocol is waiting on coverage determination.

A backlog is holding work before activation.

An audit surfaced billing or designation errors.

A migration left grids or study records obsolete.

A new study design introduces unfamiliar financial dependencies.

Portfolio growth is straining available capacity.

An amendment has broken alignment across artifacts.

The starting point is unclear.

RECONCILIATION & REPORTING

Make every movement answerable.

RECONCILIATION LOOP

TRIGGER DOCUMENTED

Capture the event, approved source, owner, and timing.

INVOICE VERIFIED

Test against agreement, budget, scope, and supporting record.

VARIANCE RESOLVED

Record the difference, decision, rationale, and owner.

CLOSE RECONCILED

Confirm activity, payments, agreements, and open items.

REPORTING SURFACES

WHAT CHANGED

WHAT REQUIRES APPROVAL

WHAT IS AT RISK

WHAT CLOSES NEXT

FAQ

Questions before the work begins.

Scope, access, authority, exception handling, and handoff should be resolved before delivery begins.

What is a Medicare Coverage Analysis?

When should the financial work begin?

What inputs are required to start?

What can KARAMATA own?

What does the client retain?

Can work occur inside client-controlled systems?

How are access and data-handling requirements defined?

How are disagreements or exceptions handled?

What happens if an error is found?

What remains at handoff?

Protect the financial line before the next handoff.

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