Streamlining Clinical Trials: A CTMS Case Study | Softqube
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Governments

Key Highlights

  • Data driven decisions/interventions towards proactively managing costs and controlling utilizations.
  • Continuous improvement of compliance to prevention and quality measures by enabling providers with timely impact analysis.
  • Allowing for a robust set of metrics and KPIs supported by high-quality, rich data to measure performance by a multitude of dimensions such as by community, by individual, by disease etc.
Patient Management

Patient Management
(Web, Mobile)

  • Recruitment
  • Retention
  • Result
Client Management

Client Management

  • Data Analytics
  • Clinical Project Management
  • Site Management
  • Clinical Supply Management
Document Management System

Document Management System

  • Patient Document Management
  • Project Management
  • Document Search
  • Version Control and Management
Study Coordinator

Study Coordinator (Web, Mobile)

  • Study Management PI
  • PI (Primary Investigator Management)
  • Patient Monitoring and Screening
  • Geographical Base Searching
User Management

User Management

  • User Creation
  • Import User From Active Directory
  • Role Based Management
  • User Role Mapping
SMART

SMART

  • Clinical Project Management
  • Trial and Site Management
  • Patient Mapping
  • Referral Tracking
  • Reward Management
Business Intelligence

Business Intelligence

  • Clinical Trial Performance and Reporting
  • Threat Detection
  • Data Archiving
  • Report Writing Service
EDC Electronic Data Capture

EDC – Electronic Data Capture

  • EDC Form Builder
  • eCRF Development and Validation
  • Bi-directional Pull and Push
  • Template Library and Business Rule Set Up
  • Lab Integration and Reporting

Capabilities or Enhancement Plans

Centralize

  • Data structure should be centralized and well partitioned.
  • Syncoset Core Framework should be web based and deployable on cloud environment.
  • Centralize Role based user management.
  • Logical separation of physical, logical and business application layers, conducive to add-ons and rapid business requirement changes.
  • Web integration layer offers branding, security, application bundling and user reporting enhancements.

Framework

  • Syncoset Core Framework should be developed as a Framework.
  • Every individual module deploy or install over the Syncoset Core Framework framework.
  • All 3rd Party and BIOCLINICA Integration management through framework.
  • Every individual module (SMART, Study Coordinator, etc.,) should be exchange data through WebAPI only.
  • Extensible DQ framework to accommodate additional client specific business rules.

Reporting

  • Powerful web-based analytics and reporting process that allow drill down into specific business need.
  • Need to develop Business Intelligence as independent module.
  • Under BI need to develop OLAP (Online Analytical Processing).
  • Data Archiving is an important part to get maximum performance and reduce the size of data.
  • ETL data driven mapping process that allow refreshing of data at required time interval.

user Management

Active Log Login Log management
User
Maintenance Role
Management Active Directory User Import

Business Intelligence

Data Archive ELT Process OLAP
JS Chart
D3JS.Org SSAS/SSRS
SQL Services Logi/Spot
Fire Report

Patient Management

Contacts Patient Maintenance Resource
Recruitment Retention iPhone App

Document Management

Version Control Doc. Vault Wiki. Medici

Study Coordinator

Geographical Search Screening of Patient
Customize
Dashboard Monitoring
of Patient iPad App
Client Management
Sponsor Management
Survey Management

SMART

PI
Management project
Management Patient
mapping Site
Management
Reward
Management Patient
Maintenance Order
Fulfillment
Referral
Tracking Visit
Management

EDC Electronic Data Capture

Near Term product evolution

  • We can design separate iPad version for Study Coordinator.
  • iPhone or Android version for Patient Access.
  • Data Archiving or OLAP Development.
    • Data Archiving specially help in removing inactive data from database for improving performance of the system.
    • OLAP (Online Analytical Processing) help to performs multidimensional analysis of business.
patient management

Long Term product evolution

  • CRM (Customer Relationship Management) for Patient recruitment and Medici Client management very much helpful.
  • We can develop an FAQ for supporting Knowledge Management
  • Design and Develop Mobile App for Trainee to get knowledge about over all processes and get status updates about application request
  • Trainee get training schedule updates and instructor information
  • Implementation of Chatbots for Trainee or other applicants
  • Also we can design drugs information portal or handy iPAD or iPhone application through which Medici Client like (Pfizer, Abbott) can publish drug related information to Doctors or Site Managers directly. It should be a replacement of MR (Medical Representatives)
    • Get your message to more physicians
      • Rural physicians can now get your messaging
      • Physicians can also easily request for samples
    • Basically entire solution is very much cost effective then sending Medical Representative (MR) to every individual physicians

Patient Management

Patient Database

  • Patient search
  • Patient Information Search
  • Mobile App for Patient
  • Content with Agent or Medical Representative
  • Map the Patient With Site

Patient Follow-up And Management

  • Bring Patient / Subject Data to System and Assign to Project or Site
  • Project or Site Project Management Under the Sponsor
  • Assign Site and PI to Project
  • Create Monitor and Assign to Site
  • Patient / Subject Pre-Screen
  • Site Management
  • PI Management
  • Patient Follow-up
  • Search and Reports

Study Coordinator / Patient Recruitment

  • Agent / Site Signup or Management
  • Lead Management
  • Contacts Management
  • Contract Signup
  • Patient Pre-screen and Site Visit
  • Activity Management
  • Patient Retention
  • Digital / Social Media Marketing
  • Survey Management

Sponsors Management

  • Sponsor Registration and Management
  • Site Mapping and Management
  • Drugs / Products Catalogue Management
  • Order Management
  • Sample and Delivery Management

Business Process Model

Business Process Model
Business process model 1

Data Architecture Framework

data architecture framework

Highlights

  • The framework depicts key building blocks towards enabling current and future analytics capabilities.
  • Multitenant platform, designed for scalability, optimal SaaS operations, HIPAA security, adhere to Service Oriented Architecture (SOA) guiding principles.
  • Loosely coupled modular architecture allow faster system / data integration and swap outs (plug and play).
  • SOA provides higher transparency, protocol independence, ease of maintenance (smaller IT staff footprint) and more creative resource options.
  • Metadata driven batch integration framework that is scalable, recoverable, interoperable, auditable and platform agnostic.

A Top Level View of Data/Process Touch Points

Data Source
Data process tabs

BI Layers

analytics solution
BI mobile images

Architecture

CONSUMERS

Business
Intelligence Self-Service
Analytics Data
Science 360°
view Transactional
applications

TIBCO DATA VIRTUALIZATION

Access Any
Data Source Combine &
Transform Optimize &
Secure Deliver
Data

DATA SOURCES

Packaged
Apps Excel &
Flat Files Data
Lakes XML
Docs Web
Services Cloud
Data
Master &
Reference Data RDBMS Data
Warehouse Big Data ioT / Streaming
Data

features

Distributed In-memory Processing

Scale high speed analytics to thousands of users and millions of rows of data on 32- or 64-bit OS laptops and clustered servers

Free Dimensional Ad Hoc Queries

Replace 100s of reports with on-the-fly aggregations, hierarchies and custom metrics.

Instant Interactive Visualizations

Auto-configured based upon the underlying data itself – minimizes pre-processing efforts.

Guided Analytics™

Unlock business expertise and reduce IT work loads with user created point-and-click workflows or event-driven broadcast distribution of analyses.

Adaptable & Extensible

End-user adapted to type of analysis plus Microsoft Visual Studio C#-based Analytic Developer Kits (SDK).

Real-time, event-driven

Process monitoring and improvement

Integrated Statistics, Modeling & Data Mining

Delivering powerful applications to the enterprise and enabling collaborations between statistical experts and business professionals.

Scalability

External Scalability
Internal Scalability
Scalability

Conclusion

This case study showcases how our CTMS solution streamlined clinical trial processes, boosting efficiency and accuracy. With real-time insights, automated tasks, and seamless collaboration, our client experienced enhanced trial management. Embrace success in clinical research – explore our CTMS solutions for your next breakthrough.

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