eCRF &
Data Management Services

Talk with an Expert

eCRF &
Data Management Services

Talk with an Expert

Best combined with:

Electronic Case Report Form System (eCRF)
With Fast and Accurate Insights

The best cost-benefit eCRF and easy-to-set web solution in the market. Combined with our TriaPal ePRO and/or eCOA mobile solutions and Clinical Data Management capabilities, our services of Electronic Data Capture (EDC) excel in deliverables, timing, and quality.

 

We foster high levels of efficiency, ensuring transparency, data integrity, and data quality.

Included Features

Subject Enrollment

Data Entry

Randomization Module (IRT)

Data Verification

Reports

Query Management

Electronic Signature (PIs)

CDISC logo

Benefits of Our CRF &
Clinical Data Management Services

  • Detect early risks; allowing the user to implement early mitigation
  • Monitor open queries and alerts to the site
  • Ensure data quality.
  • Generate better outcomes.
  • Fast and accurate
  • Efficient decision-making.
  • Built-in medical dictionaries: MeDRA and WHO
  • Develop eCRF, EDC, and variable programming according to CDASH and SDTM
  • Query validation and testing 
  • Development of Data Management Tools (DMTLs), Web Reports, BI tools, and user requirement specifications.
  • Patient data audit trail to ensure timely and quality entry into the EDC system.
  • Testing of study database
  • CRF completion (data entry %, Verification %, PI Signature %)
  • Adverse Events and Serious Adverse Events coding
  • Database high-security standards for transfer and backup.
  • CRF Configuration document
  • CRF form definition document
  • Edit check and self-evident correction definition (where all checks reviewed in data cleaning are defined)
  • Annotated CRF (CDASH-SDTM)
  • CRF project user guide
  • CRF manual per role (Data Entry, CRA, PI)
  • Data Management plan (DMP)
  • Final Data Export
  • Query aging reports
  • CRF completion reports (data entry %, Verification %, PI Signature %)

A User-Friendly Solution
Colors and Icons

The status of the visits and observations are labeled with colors and icons according to the stage of each process and what is happening to it. The colors and icons are used as follows:
eCRF empty page no info

Empty page / No Info

eCRF prending queries

Pending queries

eCRF signed by pi

Signed by PI

eCRF information not verified by cra

Information not verified
by CRA

eCRF verified by the cra

Verified by CRA

eCRF Role Dashboard & Reports

Explore your clinical trial possibilities

Why Integra IT

Affordable (accessible) for small and medium size Sites, CROs, and Sponsors

Real-time data for data-driven decisions

Faster start-up studies

Interoperability (integrations between own and third-party systems)

Validated and GCP-compliant

On-demand scalable architecture (per solutions, modules, and features)

Expertise in low and middle-income countries

Vaccine-exclusive features available

Around 70% of our clinical research experts are Latin American professionals with global experience

eCRF & Clinical Data Management
Study Cases & Resources

What is Clinical Data Management

What is Clinical Data Management?

Clinical trials are essential to advancing medical science and providing patients with novel treatments. The optimization of clinical trial operations depends critically on effective data

Read More
How to choose the right eCRF

How to choose the right eCRF?

As the demand for efficient and streamlined data management in clinical trials continues to grow, with numerous vendors offering a wide range of features and

Read More

Want to know more about our eCRF & Data Management Services?

Schedule a meeting with us!

Call To Action CRF