Consent compliance under regulatory scrutiny

In 2023, FDA inspections of clinical trial sites resulted in more than 1,400 compliance observations. Many of these findings related to outdated consent forms, missing documentation, or delays in obtaining updated consents after protocol changes. Such failures often lead to regulatory citations, data exclusion, and delays in approvals. 
A major contributor to this is lack of proper documentation of reconsent from participants in clinical trials. Reconsent is sought periodically when protocols change, new safety information becomes available, or study timelines extend.  

A Fortune 500 biopharmaceutical company, ranked among the top fifteen globally by revenue, faced operational complexity and rising compliance risk. It required a structured approach to strengthen consent oversight during annual country level reviews. Operating across more than twenty five countries, till recently, the organization relied on disconnected systems and manual workflows to create 100 to 300 slide decks per country or hub. The process was time consuming, inconsistent, and offered limited visibility into compliance metrics. The company partnered with MResult to develop a structured, automated framework that would streamline reporting and ensure traceable, audit ready consent data at scale. 

 

Challenges: Consent tracking and compliance gaps in a distributed trial environment

Fragmented data and manual reporting processes 

  • No central system to access or consolidate informed consent and reconsent data across regions 
  • Consent related metrics distributed across more than ten diagnostic tools and dashboards 
  • Annual country reviews required building slide decks manually, often exceeding 300 slides per hub 
  • Manual screenshot collection and copy paste workflows consumed several days of effort per region 

Lack of structured reconsent oversight 

  • No standardized approach to verify timely reconsent after protocol amendments or extended timelines 
  • Site level comments and reconsent observations maintained in isolated Excel files by clinical staff 
  • Inconsistent documentation practices made it difficult to trace or audit reconsent actions at scale 
  • Limited ability to flag at risk studies or patients before review cycles 

Inefficient coordination between central and country teams 

  • Follow ups and clarifications between field teams and reviewers required repeated back and forth 
  • New team members lacked visibility into historical decisions or notes tied to site compliance 
  • Absence of version control and contextual commentary created gaps in institutional memory 

Limited visibility for leadership and audit readiness risk 

  • Leadership lacked real time access to country level consent compliance metrics 
  • Final review cycles were compressed due to delays in slide preparation and reconciliation 
  • Risk of outdated or incomplete consent data being surfaced during audits or regulatory inspections 

Solution: Integrated framework for streamlined consent oversight and automated compliance reporting

Centralized reporting with country level visibility 

  • Developed a unified dashboard to bring together metrics from over ten diagnostic tools 
  • Enabled granular filtering by country, hub, or study to support local and regional reporting 
  • Consolidated consent and reconsent performance data into a single, structured environment 
  • Built on Spotfire to align with existing diagnostic tools and data standards 

Automated slide generation for annual reviews 

  • Integrated scripted automation to generate operating review slide decks in a standard template 
  • Reduced effort for country teams by eliminating manual screenshot collection and formatting 
  • Enabled real time deck regeneration using current data without disrupting the underlying tools 
  • Delivered over 80 % reduction in manual preparation time for slide-based reviews 

Write back capability for site level insights 

  • Enabled clinical research associates to enter observations and follow ups directly within the dashboard 
  • Captured comments and site specific notes alongside consent data for complete context 
  • Improved traceability and coordination between field teams and central reviewers 
  • Eliminated the need for external Excel trackers or ad hoc documentation 

Secure and scalable data infrastructure 

  • Integrated with Databricks to source validated, near real time data into the reporting layer 
  • Ensured data integrity and version control through centralized architecture 
  • Designed to accommodate evolving metrics and compliance requirements across studies 
  • Supported ongoing enhancements without rework to existing reporting logic 

Benefits and Business Impact: Improved compliance confidence and reduced reporting burden

  • Up to 80 % reduction in manual effort for country level reporting and review preparation 
  • Improved traceability of reconsent actions and site level follow ups 
  • Consolidated data and embedded commentary reduced time spent on clarification loops 
  • Country teams could access pre-structured reports with current data for faster decision making 
  • Clinical research associates no longer relied on disconnected Excel files to track consent status 
  • Leadership gained real time visibility into compliance performance across all geographies 
  • Reduced risk of consent documentation lapses during formal audits and inspections 

Creating a foundation for scalable compliance solutions

The solution developed for consent and reconsent tracking is now informing additional compliance workflows across the organization. Its structured approach to documentation, version control, and site level visibility is being adapted for use in adjacent functions where audit readiness and data traceability are critical. The engagement has established a repeatable model for aligning process design with evolving regulatory expectations.