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CAPABILITIES / 01 CLINICAL RESEARCH FINANCE FIG. 01

CAPABILITIES / 01 CLINICAL RESEARCH FINANCE FIG. 01

CAPABILITIES / 01 CLINICAL RESEARCH FINANCE FIG. 01

One financial
line.

One financial
line.

One financial
line.

From coverage decision to amendment.

From coverage decision to amendment.

From coverage decision to amendment.

From coverage decision to amendment.

Six financial artifacts, one workstream, one named owner. Nothing re-keyed, nothing re-negotiated on the way to the study record.

Six financial artifacts, one workstream, one named owner. Nothing re-keyed, nothing re-negotiated on the way to the study record.

TALK THROUGH YOUR STUDY

24-HOUR RESPONSE · NAMED SENIOR OWNER · NO SALES DESK

24-HOUR RESPONSE · NAMED SENIOR OWNER · NO SALES DESK

FIG. 02 — WHERE TO START

FIG. 02 — WHERE TO START

START HERE

START HERE

Pick the sentence that is true this week.

Pick the sentence that is true this week.

Pick the sentence that is true this week.

Pick the sentence that is true this week.

A protocol is waiting on coverage

A backlog is compounding

An audit found something

A CTMS migration is underway

A dependency we have not seen before

Capacity is strained

An amendment misaligned the artifacts

We are not sure where to start

YOUR SITUATION

A protocol is waiting on coverage.

Start-up is gated on a determination no one has capacity to write. Every week of delay is a week of accrual lost.

WHAT WE WOULD DO FIRST

01 Protocol, schedule of events and ICF received.

02 Determination drafted with citations · entry 01.

03 Grid built from the determination · entry 02.

04 Named owner on the line within 24 hours.

DISCUSS THIS STUDY

FIG. 03 — THE PREMISE

FIG. 03 — THE PREMISE

THE PREMISE

THE PREMISE

Funding is not
the same as readiness.

Funding is not
the same as readiness.

Funding is not
the same as readiness.

A signed budget with an unfinished coverage determination is a study that will stall at first invoice. The documents are only as strong as their agreement with each other.

A signed budget with an unfinished coverage determination is a study that will stall at first invoice. The documents are only as strong as their agreement with each other.

A signed budget with an unfinished coverage determination is a study that will stall at first invoice. The documents are only as strong as their agreement with each other.

7

7

7

months, on average, from site identification to completed study start-up.

months, on average, from site identification to completed study start-up.

80%

80%

80%

of research sites hold six months or less of operating cash on hand.

of research sites hold six months or less of operating cash on hand.

31%

31%

31%

of clinical research professionals say study budgets are sufficient to support good operations.

of clinical research professionals say study budgets are sufficient to support good operations.

SOURCES: TUFTS CSDD START II BENCHMARK; SCRS 2023 SITE LANDSCAPE SURVEY; ACRP 2025 NATIONAL WORKFORCE SURVEY. INDUSTRY FIGURES, NOT KARAMATA CLAIMS.

SOURCES: TUFTS CSDD START II BENCHMARK; SCRS 2023 SITE LANDSCAPE SURVEY; ACRP 2025 NATIONAL WORKFORCE SURVEY. INDUSTRY FIGURES, NOT KARAMATA CLAIMS.

FIG. 04 — THE LEDGER

FIG. 04 — THE LEDGER

THE LINE · SIX ENTRIES

THE LINE · SIX ENTRIES

Each entry inherits the one before it.

Each entry inherits the one before it.

01 — 06

01 — 06

ENTRY 01

ENTRY 01

Medicare Coverage Analysis

Medicare Coverage Analysis

Every protocol item designated routine care or sponsor-paid, with the supporting citation written beside it.

Every protocol item designated routine care or sponsor-paid, with the supporting citation written beside it.

WHAT IT MEANS

WHAT IT MEANS

Signed coverage determination

Signed coverage determination

ENTRY 02

ENTRY 02

Billing Grid Review & Build

Billing Grid Review & Build

Visits mapped to payer responsibility so the grid and the determination cannot disagree.

Visits mapped to payer responsibility so the grid and the determination cannot disagree.

WHAT IT MEANS

WHAT IT MEANS

Payer-mapped billing grid

Payer-mapped billing grid

ENTRY 03

ENTRY 03

Sponsor Budget Analysis

Sponsor Budget Analysis

Each line item tested against the grid. Unfunded procedures surfaced before anyone signs.

Each line item tested against the grid. Unfunded procedures surfaced before anyone signs.

WHAT IT MEANS

WHAT IT MEANS

Budget variance memo

Budget variance memo

ENTRY 04

ENTRY 04

CTA & SOW Review

CTA & SOW Review

Operational and financial terms read against each other. Inconsistencies itemised for your counsel.

Operational and financial terms read against each other. Inconsistencies itemised for your counsel.

WHAT IT MEANS

WHAT IT MEANS

Redline issues list

Redline issues list

ENTRY 05

ENTRY 05

REC Forms & CTMS Build

REC Forms & CTMS Build

System records configured from the signed artifacts, not re-keyed from memory.

System records configured from the signed artifacts, not re-keyed from memory.

WHAT IT MEANS

WHAT IT MEANS

Configured study record

Configured study record

ENTRY 06

ENTRY 06

Amendment Budget Support

Amendment Budget Support

Each protocol change assessed across determination, grid, budget and agreement together.

Each protocol change assessed across determination, grid, budget and agreement together.

WHAT IT MEANS

WHAT IT MEANS

Amendment impact ledger

Amendment impact ledger

KARAMATA owns the mapping, designation and analysis. Your organization keeps legal authority, policy decisions, billing submission and system control.

KARAMATA owns the mapping, designation and analysis. Your organization keeps legal authority, policy decisions, billing submission and system control.

FIG. 05 — BEFORE WE BEGIN

FIG. 05 — BEFORE WE BEGIN

PRACTICAL ANSWERS

PRACTICAL ANSWERS

A few practical questions.

A few practical questions.

A few practical questions.

A few practical questions.

The answers most teams need before the first call. If yours is not here, ask it directly.

The answers most teams need before the first call. If yours is not here, ask it directly.

How do a Medicare coverage analysis, a billing grid and a clinical trial budget work together?

−

The coverage analysis decides, item by item, what may qualify as routine care and what the sponsor is expected to pay for, and records the citation behind each decision. The billing grid applies those decisions to every visit and procedure in the schedule of events. The budget is then read against the grid, so any procedure the sponsor has not funded shows up as a variance before signature, not at first invoice. KARAMATA connects and documents the three. Your organization retains responsibility for final billing determinations and approvals.

Can KARAMATA review an existing billing grid or budget, and support protocol amendments?

+

Can KARAMATA build or update financial study records in our CTMS?

+

What does KARAMATA review in a clinical trial agreement or statement of work?

+

What should we have ready to start a clinical research finance engagement?

+

FIG. 06 — LET’S TALK

FIG. 06 — LET’S TALK

START A CONVERSATION

START A CONVERSATION

Bring us the question
in front of you.
We’ll find the next step together.

Bring us the question
in front of you.
We’ll find the next step together.

Bring us the question
in front of you.
We’ll find the next step together.

Tell us about the study, its current stage, and the part that needs attention. We’ll look at it with you, say plainly what we see, and suggest a first step. A real person replies within 24 hours — no sales desk, no deck.

Tell us about the study, its current stage, and the part that needs attention. We’ll look at it with you, say plainly what we see, and suggest a first step. A real person replies within 24 hours — no sales desk, no deck.

DISCUSS YOUR STUDY

OPERATIONS@KARAMATACLINICAL.COM · (888) 407-5682

OPERATIONS@KARAMATACLINICAL.COM · (888) 407-5682

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ADDRESS
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