The Customer

A global pharmaceutical company creating a future where disease is a thing of the past by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. It focuses on specific therapies where it makes the biggest difference - cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology, and pulmonary hypertension..

Challenges

  1. Managing multiple stakeholders in the regulatory planning and submission process delaying the process

  2. Low compliance for health authority query responses

  3. Non-comprehensive intelligence on multiple European markets

The Solution

Indegene deployed a team with deep knowledge of European clinical trial and regulatory requirements in a flexible operating model.

We seamlessly integrated Indegene SMEs and experts with client systems and processes, trained on their internal SOPs.

We scaled our team to manage entire CTA lifecycle (prepare, compile, submit, archive) on behalf of the client.

Indegene ensures compliance with clinical trial submission requirements
100%
Compliance to regulatory guidelines
99.5%
Right first-time submissions
100%
Adherence to internal metrics
Indegene ensures compliance with clinical trial submission requirements

Outcomes

  • Indegene furthered this client’s goal of creating a future where disease is a thing of the past by enabling its regulatory operations be fully compliant, improving effectiveness and efficiency, and being future ready

  • We ensured 100% compliance to regulatory guidelines, 99.5% right first-time submissions and 100% adherence to internal metrics