CRF & Data Management Services

Data Management Services

Fast and Accurate Insights

Our team has a proven methodology that combined with and integrated and automated data management practices. We foster high levels of efficiency, ensuring transparency, data integrity and quality of your data.

Our service embedded in a project management discipline will:

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Allow early problem solving.
Send notifications and alerts to sites.
Ensure Data Quality.
Receive better outcomes.
Give you speed and accuracy.
Ensure better and faster decision making.
Include two dictionaries (MeDRA and WHO) that give advice regarding the standard medical and medicines terminology.

Data Management over our CRF takes advantage of automatic checks, and automatic tasks to ensure speed and error free processes.

Our CRF is already integrated and synchronized with our PFS (Patient Follow Up System), used by sites to manage a clinical trial; thereby reducing errors and costs in data transfer or digitalization.

eCRF & Data Management Services

Develop Case Report Form eCRF

Development of Study Database (EDC)

Develop and Programming Variables according to CDASH Standard and SDTM Standard Conversion

Programming of Auto-Query validation into study database

Development of Data Management Tools (DMTLs) and / or Web Reports

Development of User Requirement Specifications of Database

Testing of Study Database

Testing of Queries

Data Management Tools (DMTLs) and / or Web Reports Development

BI Tools

Query aging

CRF completion (data entry %, Verification %, PI Signature %)

Patient data audit trail to ensure timely and quality entry in EDC system

Coding of Adverse Events and Serious Adverse Events(MedDRA)

Coding of Concomitant Medications (WHO-DDE Dictionary)

Periodic data cleaning with data management query creation or self evident corrections.

Database lock prior to Database Transfer (end of study)

Database automatic backup

Data Export in csv, xsl, or SAS format

Data Management Deliverables

CRF Confguration 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 rol (Data Entry, CRA, PI)

Data Management plan

Final Data Export

Query aging reports

CRF completion reports (data entry %, Verification %, PI Signature %)

Data management Experience

Polio Phase 2 study - Colombia
Polio Phase 2 study - Panama, Dominican Republic
Real World Evidence (RWE) birth control - Peru
Breast Cancer (RWE) - Colombia
mCRPC (RWE) - Colombia
Norovirus Observational study - Panama
Sexual Arousal Disorder Phase 3 - Colombia
Real World Evidence (RWE) Asthma - Colombia, Argentina, Persian Gulf, India, Chile, Turkey, Saudi Arabia)

eCRF and Data management Experience

Using our eCRF and Services :

Our eCRF uses CDASH standard and allows Data export in SAS format for Statistics Analysis. Also available in Excel and CSV.

Easy CDISC compliance due to CDASH and SDTM standard conversion according to study needs.

Completed:

Polio Phase 2 study - Colombia (Vax Trials - Bill & Melinda Gates Foundation) - 2014
Polio Phase 2 study - Panama, Dominican Republic (Vax Trials, FIDEC) - 2017

Ongoing:

Real World Evidence (RWE) birth control - Peru (JSS, Bayer) - 2020
Norovirus Observational study - Panama (Cevaxin, Takeda) - 2020
Breast Cancer (RWE) - Colombia (JSS, Pfizer) - 2020
Prostate Cancer (RWE) - Colombia (JSS, Bayer) - 2021
Sexual Arousal Disorder Phase 3 - Colombia (JSS, Litaphar) -2021

We develop solutions as a service, take a look at how they work.

Case Report Form System

CRF & Data Management Services

Our eCRF is a WEB EDC system developed in order to allow users to enter, verify, and sign clinical trials information, where the following functionalities are enabled.

Randomize Subjects

Enroll Subjects

Enter Data

Verify Information

Manage Queries

Add Electronic Signature (Pls)

Download Reports

The mentioned functionalities can be performed by the following roles, depending on the access specified for each one:

Data Entry

CRA

Private Investigator

Our eCRF is already integrated and synchronized with our PFS (Patient Follow Up System), used by sites to manage a clinical trial, thereby reducing errors and costs in data transfer or digitalization.

Role Dashboards

Data Entry Role

The person in charge of entering the information will have the Data Entry role. This role can:

Randomize Subjects
Enroll Subjects
Enter Data

CRA Role

The CRA is the person in charge of verifying and managing queries. This role can:

Verify Information
Manage Queries
Download reports

Principal Investigator

The principal investigator verifies the information and signs it for approval. This role can:

Add Electronic Signature (Pls)
Download reports

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:

Empty page / No info

Information not

verified by CRA

Pending queries

Verified by the CRA

Signed by PI

If you want to know more about how our systems are validated and comply with 21 CFR Part 11

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Reports

Surveillance Reports

Investigators and CRAs can generate the following surveillance reports to see how the Trial is progressing:

General Tracking Report
Query Tracking Report
Visit Report
Monitoring Visit Report

Predefined Reports

Administrators can also create reports with personalized information obtained from the databases for particular queries. These reports can be set up at the beginning or during the Trial on an on-demand basis, and at no additional cost.