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SMR (Source Medical Records)

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Unlike traditional solutions, Clincove's SMR

system captures and stores source-level

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Visists

Consents

Source Medical Records

Adverse Events

Medical History

Contaminant Meds

Visits

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Visit Type

Screening

Baseline

Treatment

Follow-up

Screening

Baseline

Treatment

Follow-up

Screening

Study Arm

A

B

C

Placebo-Controlled

Experimental

Active Comparator

Combination Therapy

Expected Visit Day

Day 1 (-3/+5)

Day 5 (-2/+2)

Day 10 (-3/+5)

Day 19 (-3/+3)

Day 24 (-2/+2)

Day 30 (-3/+5)

Day 37 (-2/+2)

Visit Date

Dec 1, 2024

Dec 5, 2024

Dec 15, 2024

Schedule Visit

Dec 15, 2024

Dec 23, 2024

Dec 29, 2024

Jan 5, 2025

Schedule Visit

Status

Scheduled

In Progress

Pending

Cancelled

Completed

Scheduled

In Progress

Pending

Cancelled

Action

Visits

30

Files

Follow-up Visit

High Dose

Initial Consultation

High Dose

Lab Test Appointment

High Dose

Medication Review

High Dose

Specialist Referral

Low Dose

Sanofi

Pre-Selection

Aegis

PFE-CV-2024

Dr. John Watson

Phase 1

(5/15)

33%

EDC (Electronic Data Capture)

User Friendly, Automated, Next Generation EDC

Process data faster and reduce site burden via our integrated EDC. Higher quality data for better outcomes.

Direct access to raw patient data

Automated data entry

AI driven data review

eISF + eTMF Integration

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Keep sites and sponsors on the same page

with Clincove's fully integrated, compliant eISF

and eTMF.

Email-to-ISF uploads

Version control

Regulatory peace of mind

For Review

205

Submitted

5

Attention

150

Rejected

50

View Study Patients

150

Attention

50

Rejected

1,200

Reviewed

200

Finalized

Completed

1,400

Reviewed

1,200

Finalized

200

View Study Patients

Participants must be at least 18 years old

Inclusion Criteria Summary for Dummy Protocol

The inclusion criteria outline the specific characteristics that participants must have to be eligible for this fictional study, “A Phase 3 Study of DummyDerm in Participants with Dummy Dermatitis (DD)”. Note that all data here is purely for demonstration purposes.

Dummy Dermatitis (DD):

Participants must have a diagnosis of Dummy Dermatitis for at least 1 year, based on the Dummy Dermatology

months prior to the screening visit

Page 11

Inadequate Response to Topical Treatments:

Participants must have a documented history of an inadequate response to topical treatments within the 6

months prior to the screening visit

Page 12

Disease Severity:

• Dummy EASI score of 16 or greater at the baseline visit

Page 13

• Dummy vIGA-DD score of 3 or 4 at the baseline visit

Page 14

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12

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12

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Create Date

Feb 6, 2025

Feb 6, 2025

Feb 6, 2025

Feb 6, 2025

Feb 5, 2025

Feb 4, 2025

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Feb 2, 2025

Feb 2, 2025

Feb 1, 2025

Actions

Not Started

3

Files

Schedule Appointments with Patients

High

Dr. John Watson

Due In: 15 days

Track Progress with Studies

Medium

Dr. John Watson

Due In: 15 days

Analyze Data with Graphs

Low

Dr. John Watson

Due In: 15 days

Add

Files

In Progress

4

Files

Manage Access with User Roles

High

Dr. John Watson

Due In: 15 days

Monitor Compliance with Alerts

High

Dr. John Watson

Due In: 15 days

Log Issues with Patients

Medium

Dr. John Watson

Due In: 15 days

Share Updates with Teams

Low

Dr. John Watson

Due In: 15 days

Add

Files

Completed

3

Files

Review Outcomes with Reports

High

Dr. John Watson

Due In: 15 days

Sync Data with Systems

Low

Dr. John Watson

Due In: 15 days

Coordinate Tasks with Teams

Medium

Dr. John Watson

Due In: 15 days

Add

Files

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