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Data Management

 

The DiagnoSearch Life Sciences Difference

At DiagnoSearch, we achieve the goal of ‘Clean Data’ by defining at the beginning clear objectives for the collection of data followed by efficient, suitable and user-friendly data field options, continuous data cleaning and seamless data integrations.

Over the last 21 years, we have witnessed the transition of Data Management processes and technologies from complex, resource dependant paper based systems to seamless and integrated cloud base applications. This allows all the stakeholders of the project to interpret, analyse and act on the data on real time basis to review trends, ensure patient safety and meet study objectives.  

Technology Platforms

DiagnoSearch’s Clinical Data Management Team is platform-agnostic and has experience on working with a wide range of clinical data management systems including our own software ‘Electron’. We offer appropriate clinical database options to our clients based on the phase of the study, number of sites, subjects and complexity of the data (integrations, number of data points per module, etc).

Our current portfolio of database solutions includes:

  • Oracle InForm: It is an integrated electronic data capture and management solution that can reliably accelerate study design and deployment, while scaling to global trials with complex protocols and large patient populations. InForm based trials are designed and validated in  local environment in our Central Designer platform before being hosted on a secure cloud, managed and regulated by Oracle. 

  • Oracle RDC: It is a single clinical database that supports centralized data management with flexibility in study set-up for both EDC as well as paper CRF based studies.

  • Electron: This is an in-house developed, comprehensive, 21 CFR Part 11 compliant data management software - for both EDC and paper CRF based studies. Electron gives us an edge in completing complex configurations for even the most expansive data sets in a timely and cost effective manner due to its unique database design and support of our in-house development team.  

Project Life Cycle

DiagnoSearch’s Clinical Data Management Team has extensive experience in managing the end-to-end process for EDC and paper CRF based projects across all phases of drug development.

Our Clinical Data Management services include:

Study Start-upPhase:


  • Inputs to Protocol Data Management section

  • Development of Data Management Plan (DMP)

  • CRF Design and Development

  • CDASH compliant CRF Annotations and Review

  • CRF Completion Guidelines

  • Database Design and Development

  • Development of Validation Checks

  • Edit checks Programming

  • User Acceptance Testing for Entry Screens and Validation Checks

  • Quality Control Checks

  • Software Training to Users

  • ‘Go-live’

Conduct phase


  • Site Team Training on the Study Prototype

  • User Access Management and IT Helpdesk

  • Data Entry (double data entry, in case of paper CRFs)

  • Discrepancy/Query Management

  • Medical Data Coding using latest versions MedDRA and WHO-DDE

  • Local Laboratory Data Management

  • External Data Integration and Reconciliations

  • Serious Adverse Event (SAE) Reconciliation

  • Manual Data Listings Review

  • Customized Study Metric Reports

  • Quality Control Checks

Database Lock


  • Database Freeze (soft lock)

  • Data Transfer to SAS platform

  • Data Review and QC by Biostatistician

  • Database Lock (Hard Lock)

  • Data Archival 

Integration with Wide-Angle-Data


At any stage during the project, the data can integrate with ‘Wide-Angle-Data’, DiagnoSearch’s one of its kind comprehensive data review system for a systematic, focussed review by key stakeholders. Being source agnostic, Wide-Angle-Data can import data from all software systems.

Why DiagnoSearch?

  • Robust Processes to ensure compliance to data standards and data integrity

  • CRF data fields in compliance with CDASH standards

  • Our Global Libraries that help us achieve quick ‘Go Live’

  • Experienced Team who understands the data flow and mapping

  • Experienced eyes that clean the collated data

  • Wide range of therapeutic experience

  • Ability to offer multiple database platforms and achieve integrations with in-house IT support

  • In-house Medical and Statistical team involved in the process from Study Design to Database Lock

  • Ability to integrate any data into 'Wide-Angle-Data' DiagnoSearch's one of its kind comprehensive Data Review System

  • Proven track record of achieving ‘Clean Data’within the stipulated timelines.

  • Oracle’s preferred Service Provider in the region.

 

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