Case Study: Improving Clinical Trial Management for Pharma

Challenge:

A growing pharmaceutical company needed expertise to navigate regulatory requirements, streamline R&D processes, and optimize clinical trials without long-term hiring commitments.

Solution:

Using Subject Matter Expert as a Service (SMEaS) to provide scalable, on-demand access to experts in life sciences focusing on:

1. Regulatory Compliance

   • Provided experts for compliance with international/local regulations.

   • Conducted audits and assessments.

   • Developed strategies for efficient regulatory submissions.

2. Research and Development Optimization

   • Expertise in biostatistics, pharmacokinetics, and pharmacodynamics.

   • Improved methodologies and experimental designs.

   • Enhanced data analysis and interpretation.

3. Clinical Trial Management

   • Supplied experienced trial managers for oversight.

   • Streamlined protocols and recruitment processes.

   • Monitored trial progress with adherence to standards.

Implementation Phases:

• Needs Assessment: Discussions to understand needs and define SME value.

• Expert Matching: Selection based on qualifications and project requirements.

• Project Execution: Deployment, knowledge transfer, and scalable involvement.

Results:

• Enhanced Regulatory Compliance: Faster approvals, 20% reduction in time-to-market, minimized compliance risks.

• Optimized R&D: 15% increase in successful outcomes, 10% cost reduction.

• Improved Clinical Trials: Accelerated timelines, 25% increase in recruitment rates.

Conclusion:

SMEaS provided the pharmaceutical company with specialized expertise to overcome operational challenges, leading to improvements in compliance, R&D, and clinical trial management.