Clinical Trial Management and Regulatory Submission for a Global Contract Research Organization
Overview
The Customer is a leading, global contract research organization. They have more than 4,300 employees working across 47 countries to deliver collaborative clinical development services and solutions.
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Challenges
Difficulty in comprehending trial Sponsor’s requirement leveraging Interactive Voice/Web Response System (IXRS) and Electronic Data Capture (EDC) framework suppliers, leading to delay in work
Difficulty in project management due to lack of data quality and clear data exchange
Solution
- ACL co-ordinated the Clinical Trial, managed different stakeholders and regulatory submission for trial data
- Established a robust administration structure between the Sponsor and the facility service providers
- Enabled transparency between organizations and improved data quality
- Coordinated with all the stakeholders and provided a clean and accurate trial report for submitting to the FDA. The transparent coordination driven by ACL enabled them to successfully meet the set timeline and budget
Outcomes
- Real time insights into Trial operations
- Improved Regulatory process
- Increased Staff efficiency and management
- Efficient budget Management and on time submission
