The Customer

A global healthcare leader that helps people live more fully at all stages of life through its portfolio of life-changing technologies across diagnostics, medical devices, nutritionals and branded generic medicines. Operating for over 130 years in more than 160 countries, putting science and innovation to work – to create more possibilities for more people through the power of health. 

Challenges

  1. Maintaining compliance of clinical trial disclosure activities in clinicaltrials.gov and EUDRACT

  2. Limited visibility on potential impact of key changes in regulatory reforms

  3. Inaccurate tracking of project deadlines/performance metrics

The Solution

Indegene deployed a dedicated regulatory team comprising a regulatory disclosure lead and medical writers with deep clinical trial knowledge.

We supported the evaluation and summarizing of complex clinical trial data into high quality disclosure documents via direct database entry.

We also proactively tracked and analyzed evolving global clinical trial disclosure regulatory landscape and intelligence reports for decision making and supported response for Health Authority queries.

Indegene ensures full compliance of clinical trial disclosure activities
100%
On-time posting of protocol results
50% ↓
Health Authority queries
100%
Compliance of clinical trial activities
Indegene ensures full compliance of clinical trial disclosure activities

Outcomes

  • Indegene enabled this client’s mission of helping its consumers live the best life, now and in the future by enabling its clinical trial disclosure activities be future ready

  • We did so by ensuring 100% on-time posting of protocol results, 50% Health Authority queries and 100% compliance of clinical trial activities