The Case for Faster, Smoother Approvals
Every day saved in the approval process matters. Faster reviews mean therapies reach patients sooner, investors see value earlier, and science delivers its impact without avoidable setbacks.
The encouraging news is that most delays are not because science failed. They happen because submissions were not fully supported by strong data foundations. That is a challenge within every company’s power to fix.
When biostatisticians and regulatory experts are freed from chasing down integration issues, they can focus on what matters: demonstrating science with clarity and confidence.
Organizations that align their data architecture with regulatory needs and not just technical performance see measurable benefits: fewer delays, stronger valuations, and submissions that stand up under review.
The Real Value of Getting This Right
Unified data → Confident submissions → Faster approvals → Market success
With the right foundation, science translates smoothly into regulatory success. Strong data architecture ensures that promising therapies move quickly and reliably toward approval without last-minute surprises.
The decision that turns a multibillion-dollar investment into market success does not just happen in the lab. It happens when leaders design systems with regulatory outcomes at their core.
Three Critical Architecture Essentials
Unified → Regulatory-Ready → Submission-Ready
- Unified by Design Modern platforms bring clinical, nonclinical, and biomarker data together in one place, avoiding the headaches of fragmented systems.
- Regulatory-Ready Optimization System choices are guided by regulatory requirements such as validation, audit trails, and traceability so compliance is built in from the start.
- Always Submission-Ready Continuous validation and reconciliation mean datasets are complete and dependable long before a deadline arrives.
Two Different Worlds
- Feature-Driven Systems Some organizations still assemble tools based on checklists. These systems may perform individually but often struggle under regulatory pressure, causing costly rework.
- Outcome-Driven Architecture Leaders take a different approach. Systems are submission-ready from day one with integration standards shaped by regulatory expectations. This creates smoother submissions, faster approvals, and a sustainable edge.
What sets leaders apart today will soon become the baseline. Acting early defines tomorrow’s standard of excellence.
What Strong Leadership Looks Like
The organizations leading the way share three common practices:
- Submission-First Design Every decision supports the quality of the submission package.
- Business-Led Integration Scientific and regulatory teams define data needs, and IT builds to those requirements.
- Quality at the Core Compliance and traceability are embedded from the start, not added later.
The outcome is submissions that withstand scrutiny, approvals without avoidable delays, and therapies delivered to patients sooner.
Executive courage: Making the hard calls that ensure regulatory success before problems emerge.
The Numbers That Matter
Companies with business-driven data strategies consistently submit earlier, avoid costly fixes, and strengthen approval outcomes.
And the investment? Modernizing architecture usually costs only a few million per program, a fraction of the billions at stake. The return is undeniable.
The Window Is Closing
Momentum is accelerating across the industry. Early movers are already showing what is possible: faster submissions, stronger approvals, and greater market confidence.
Aligning data architecture to regulatory outcomes is no longer optional. It is a proven competitive advantage. What differentiates today will soon be the baseline, and those who move early will define the pace for tomorrow.
Three Questions Every Executive Should Ask
- Who sets the direction for our data systems: business leaders focused on outcomes, or IT teams focused on features?
- If submission-ready datasets were needed tomorrow, could we deliver them without delay?
- How many of our program timelines are slowed by system issues rather than scientific complexity?
If these questions spark reflection, they highlight the biggest opportunity for improvement.
The Choice
Pharma exists to deliver life-changing therapies to patients. Yet too often, it is data architecture and not science that determines which drugs succeed.
The choice is simple:
- Accept preventable delays and missed opportunities.
- Or mandate business-driven, submission-ready systems that bring science to market faster.
In this industry, there is no prize for almost. Therapies either reach patients or competitors get there first.
About the Author: Aruna Adhikari Thapa is the Chief Product and Commercial Officer at PointCross Life Sciences, and a 2024 PharmaVoice 100 honoree recognized for her leadership in advancing the use of technology and AI across clinical development and regulatory operations. She is a product and commercial expert with over 20 years of experience scaling AI-powered SaaS businesses, transforming healthcare through data innovation, and driving enterprise growth across regulated industries.Aruna Adhikari Thapa, MBA, Chief Product and Commercial Officer