CRF & Data Management Services

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Data Management Services 

Fast and Accurate Insights

Our team has a proven methodology that combined with and integrated and automated data management practice, we foster high efficiencies, ensuring transparency, data integrity and quality of your data.

Our service embedded in a project management discipline will:

 

  • Allow early problem solving.

  • Send notifications and alerts to sites.

  • Ensure Data Quality.

  • Receive better outcomes.

  • Give you speed and accuracy.

  • Better and faster decision making.

  • Two dictionaries included (MeDRA and WHO) that give advice of the standard terms for medical terms and medicines.

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

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

  • 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
  • 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) Astma - Colombia, Argentina, 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.

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    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
    Enrol 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 therefore reducing errors and cost 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

    • Enrol 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

    Private Investigator

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

    • Add Electronic Signature (Pls)

    • Download reports

    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 CRF Part 11

    Want to get any of the solutions?

    Schedule a meeting with us

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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.

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