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FULL SERVICE DATA MANAGEMENT

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Full-Service Data Management

  • We perform end-to-end DM activities, ranging from CRF designing to DB Lock and archival (see the pic).

  • We follow well-written, simple processes that are intuitive and will make sense to you right away.

  • Our goal is deliver you clean, flawless, high quality data and we achieve this goal by:

    • Following robust ‘Study start-up practices’

    • Ensuring  all ‘External Data’ is available, reconciled and clean

    • Displaying ‘Visual charts/reports’ on project dashboards, to keep the study team updated throughout the trial

    • Performing any ‘Post-production changes’ in 1-2 weeks time frame

    • Using well-written SOPs and Study documents

    • Providing great ‘Customer Support’ throughout the duration of trial

    • We work closely with you, and strive to deliver you excellence in everyday interaction. 

“Let's Meet”, to learn more about our end-to-end DM service.

PERFORM DATA REVIEW AND CLEANING

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For your ‘Ongoing’ studies, are you satisfied with the quality of the data? If not, we can assist you.

At Simplify Clinical Trials, we split the data cleaning activities into following two steps: 

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1. Identify Data Issues

  • To identify data issues, we use ‘Smartsheets’ to perform a comprehensive review of both clinical and external data and generate a detailed ‘Data Issues Log’ to document our review findings.

  • We develop workflows that automate and reduce the turnaround time (TAT) of data review, enabling us to identify data issues as soon as discrepant data is entered in the EDC.

    • For e.g. we create workflows to perform ‘External Data Reconciliation(s)’ or create ‘Ad-hoc’ reports to monitor the study progress. 

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2. Resolve Data Issues

  • To resolve identified data issues, we meet with the study team to devise an "Action Item" and designate stakeholders responsible for resolving the issue. 

  • We proactively follow-up with the stake-holders to ensure that action items are completed and open issues are resolved in a timely manner.

  • We refresh the source data to monitor if "Open" issues are getting resolved within the expected turnaround time (TAT) and promptly alert project managers, if there are any delays.

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Our approach is to automate the “Data Review and Cleaning” process, such that the ‘System’ does the heavy lifting for us, and we’re able to reduce the time in half, perform it more frequently, which results in cleaner data.

“Let's Meet”, to learn more about our “Automated” approach to perform ‘Data Review & Cleaning’.

DATA REPORTING AND VISUALIZATIONS

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  • We create meaningful visualizations from your study data, such that you can ‘interact’ with data based on selected filters.

  • We’ve created a ‘standard’ set of visualizations that’ll apply to most studies i.e. visualizations for Lab data, Vital signs, ECG, AE, Conmed’s etc. 

    • For e.g. watch the video to visualize Lab values​

  • We can program ‘Custom/Ad-hoc’ visualizations based on your inputs & study needs.

  • Using Power BI, we create a data hub, where you can get the macro & micro insights into data from various sources.

“Let's Meet”, to learn more about our "Intuitive" suite of Standard Reports and Visualizations.

ELECTRONIC PATIENT REPORTED OUTCOME (ePRO)

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Electronic Patient Reported Outcome (ePRO)

  • We design ‘Questionnaires/Survey’ that are compliant, easy to complete by patients, at the convenience of their home using Laptop, Phone or Tablets

  • We present these ‘Questionnaire(s)’ in the most patient-centric way, to ensure higher completion & compliance rates.

    • And set-up reminders/notification, to complete questionnaires that are due for entry.

  • We create a ‘Dashboard’ that will provide ‘Completion Summary’ by each patient.

    • ​And proactively work with the team to troubleshoot any issues, preventing patients from completing Questionnaires.

MIGRATE (RESCUE) STUDY TO A NEW EDC SYSTEM

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Migrate (Rescue) study to a new EDC system

  • ​We’ve supported studies where the team felt it’s necessary to migrate the study in a new EDC system, without losing existing data.

  • We achieve this by creating a new EDC system, very similar to the ‘original’ EDC system.

  • We carefully identify & map all data between both systems. And create files for ‘Data Import’

  • We perform ‘Data Import’ into the ‘new’ EDC system to avoid any data entry errors.

    • This saves the time & cost of data entry, if data were to be entered by site. 

    • If needed, we assist with restoring the connections to external systems like RTSM, CTMS, JReview etc.

  • We perform QC to ensure data is consistent in both the system, and decommission the older DB, after data transfer  is successfully complete.

  • The timeline for DB migration can vary from 1 - 2 months, depending on the complexity of the project.

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