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PAPER · WHC 2025

CIPREC: Assessment of metrics in a research center

Comparing resource utilization before and after the incorporation of a digital protocol management system.

Dr. Fernando Guerlloy · Dr. Cesar J. Zaidman

Cardiovascular Research and Prevention Center (CIPREC)

4 years
Assessment period (2020–2024)
p < 0.001
Statistical significance
19 years
Center experience

Hypothesis

The implementation of a digital protocol management system:

Improves performance metrics
Optimizes resource utilization
Minimizes costs
Enhances data quality
Accelerates query resolution
Facilitates data transmission to the sponsor
Strengthens Principal Investigator oversight

Magnitude of the problem

Approximately 60% of research centers in Argentina use paper medical records
Of those who use digital medical records, only 10% comply with assessments (audit trail, disaster recovery policy, backup)
Data security

Objective

To demonstrate the improvement of various performance indicators in a clinical research center after implementing a digital protocol management system.

The challenges

Limited resources
Overloaded healthcare systems
Manual processes = errors + delays
Costly monitoring
Compliance demands (ICH GCP, 21 CFR Part 11, HIPAA)

Materials and Methods

In a clinical research center with 19 years of experience, metrics were compared over a 4-year period (November 2020 to October 2024), divided into two phases.

Period A
Paper based
Nov 2020 – Oct 2022
Period B
Brainmart MED CT
Nov 2022 – Oct 2024

Metrics Analyzed

Monthly visits rate
Data loading time
Monthly query rate
Query response time
Results with statistical significance

Period A (paper) vs Period B (Brainmart MED CT)

Monthly visit rate

Paper
193
Brainmart
445
+131%

Data loading time (days)

Paper
7
Brainmart
1
-86%

Monthly query rate

Paper
93
Brainmart
39
-58%

Query response time (days)

Paper
7
Brainmart
2
-71%

The number of laboratory technicians increased from 2 to 3, while the number of medical investigators, study coordinators, and pharmacy staff remained unchanged. All results with p < 0.001.

System-Wide Benefits

Patients

Faster access to care

Sites

Reduced burden and increased effectiveness

Sponsors

Lower monitoring costs, faster access to data and improved data quality

Conclusions

The digital protocol management system significantly improved performance regarding recruitment potential, resource optimization, and operational metrics. It optimized workflow across all study phases, from patient selection to data verification, resulting in measurable cost and time savings for both the center and sponsors.

Digitalization in research sites is not just a tool, it is a mindset shift. The evidence is here. The next step is adoption.

CIPREC · Buenos Aires, Argentina

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