Case Studies

Real-world clinical trials powered by the Wide Angle Insights platform

Overview

In the light of the fast-spreading COVID-19 pandemic, one of the largest vaccine manufacturers in the world believed that a prophylactic vaccine currently under development for another indication could possibly offer protection to high-risk groups. The need was to start the trial as soon as possible to ensure early availability.

Challenges

  • Set-up and activation of clinical trial systems i.e. eCRF, ePRO / eCOA, pharmacovigilance & IWRS could take a minimum of 8 to 10 weeks.
  • Considering the highly infectious nature of the disease, face-to-face consenting and paper Informed Consent Forms & Subject Diaries would be risky.
  • It was necessary to minimize in-person follow-up hospital visits without compromising on the frequency and volume of data collected.
Solution Outcome
The need for a quickly configurable integrated platform was met by Wide-Angle-Insights, with its modular architecture, inbuilt intuitive algorithms and artificial intelligence. All the integrated modules i.e. eConsent, eCRF, ePRO / eCOA, IWRS, pharmacovigilance & medical review were activated in record time, enabling initiation of subject recruitment within 3 weeks of protocol finalization. This is inclusive of time required for team training.
Mobile app with eConsent in multiple languages. This ensured that the consent was provided electronically in the preferred language without the need for paper exchange.
ePRO / eCOA within the mobile app. Drastically reduced the number of site visits by subjects.
Data completion prompts and notifications in the mobile app. Ensured timely data capture.
Integrated pharmacovigilance database – Single Source of Truth +. Sites needed to enter SAE data only once, thus reducing data entry effort and necessity of reconciliation.
Integrated medical review platform. Facilitated real time safety data review and enabled timely signal detection, adjudication, correlation, resolution and management.
Inbuilt Risk Engine that facilitates real-time Risk Management. Enhanced oversight and implementation of mitigation strategies.
Customizable, real-time updated dashboards and reports. Efficient project management and timely course correction.

Overview

In the light of the fast-spreading COVID-19 pandemic, one of the largest vaccine manufacturers in the world believed that a prophylactic vaccine currently under development for another indication could possibly offer protection to high-risk groups. The need was to start the trial as soon as possible to ensure early availability.

Challenges

  • Set-up and activation of clinical trial systems, i.e. eCRF, ePRO / eCOA, pharmacovigilance & IWRS would take a minimum of 8 to 10 weeks.
  • It was necessary to minimize in-person follow-up hospital visits without compromising on the frequency and volume of data collected.
  • Involvement of multiple stakeholders – Sponsor, Australia-based CRO for local Clinical Operations and Data Services CRO – could lead to duplication of effort.
Solution Outcome
The need for a quickly configurable integrated platform was met by Wide-Angle-Insights, with its modular architecture, inbuilt intuitive algorithms and artificial intelligence. All the integrated modules i.e. eCRF, ePRO / eCOA, IWRS, pharmacovigilance & medical review were activated in record time, enabling initiation of subject recruitment within 3 weeks of protocol finalization. This is inclusive of time required for team training.
Collaborative environment of the Wide-Angle-Insights platform with automated event histories. Seamless study conduct, smooth communication between stakeholders and complete transparency.
ePRO / eCOA within the mobile app. Drastically reduced the number of site visits by subjects.
Data completion prompts and notifications in the mobile app. Ensured timely data capture.
Integrated pharmacovigilance database – Single Source of Truth +. Sites needed to enter SAE data only once, thus reducing data entry effort and necessity of reconciliation.
Integrated medical review platform. Facilitated real time safety data review and enabled timely signal detection, adjudication, correlation, resolution and management.
Inbuilt Risk Engine that facilitates real-time Risk Management. Enhanced oversight and implementation of mitigation strategies.
Customizable, real-time updated dashboards and reports. Efficient project management and timely course correction.

Overview

A pivotal Phase III clinical trial for a promising anti-TB vaccine. The project involves a diverse spectrum of stakeholders – Funding Agency, Sponsor, Local NGO, CRO, sites and multiple analytical laboratories.

Challenges

  • Field-based study – remote locations of sites and low internet connectivity.
  • Country to country & site to site variations in source data capture practices could lead to incoherent monitoring and data inconsistencies.
  • Multiple stakeholders – possibility of duplication of effort and communication gaps.
Solution Outcome
Use of customized eSource integrated with eCRF. Standardized source data capture.
Improvisation to use IWRS, eSource and eCRF in a fully-integrated unique, first in industry 'offline' mode. Enablement of randomization, source data capture & eCRF completion even at locations with no / low internet connectivity. Increased subject recruitment speed and timely data capture.
Collaborative environment of the Wide-Angle-Insights platform with automated event histories. Seamless study conduct, smooth communication between stakeholders and complete transparency.
Integrated pharmacovigilance database. Sites need to enter SAE data only once, thus reducing data entry effort and necessity of reconciliation.
Integrated medical review platform. Real-time safety data review & timely signal detection, adjudication, correlation, resolution & management.
Inbuilt Risk Engine that facilitates real-time Risk Management. Enhanced oversight and implementation of mitigation strategies.
Customizable, real-time updated dashboards and reports. Efficient project management and timely course correction.