The Industry Challenge Large CROs are built for scale. That scale creates friction.

The Problem: Average time from site identification to start-up completion is ~8 months. 35% of sites take 91+ days to activate; only 19% report activation in 30 days or less.

The Source of Delays: More stakeholders, more handoffs (start-up, contracts, regulatory, vendors), and "queue time" across shared functions.

Prana's Solution: Fast-cycle startup playbooks with 24-48h document turnaround. Every submission tracked daily. No queue time—your study is our priority.

The Problem: ~80% of trials fail to meet initial enrollment targets or timelines. Delays can cost up to $8M per day in lost revenue for drug developers.

The Bandwidth Problem: Large portfolios compete for scarce CRA/PM/site bandwidth. "Average-case" operating cadence is too slow for rescue or priority execution.

Prana's Advantage: Dedicated teams with no competing priorities. 24-48h execution cadence keeps enrollment momentum. Performance dashboards surface issues before they become crises.

The Problem: 11-40% of activated sites enroll zero patients, depending on the study. You're paying for sites that never deliver.

The Myth of Scale: Site selection and activation processes often optimize for coverage and scale, not predictive enrollment performance per site.

Prana's Strategy: Site selection based on performance history and realistic enrollment projections. RBQM signals identify underperforming sites early for intervention or replacement.

The Problem: CRA turnover peaked at ~30% in 2022 and remains around ~22%. Each transition disrupts site relationships and introduces learning curves.

The Revolving Door: Larger organizations have higher volume hiring and reallocation. Teams work in silos despite promises of end-to-end solutions.

Prana's Model: Senior-led delivery with executive operators attached to your program from kickoff to closeout. No layers, no handoffs, no learning curves mid-study.

The Problem: Large CROs report 21-24% adjusted EBITDA margins. Their operating systems optimize for capacity management and standardization—rational, but not always ideal for high-urgency programs.

The Incentive Misalignment: At scale, economic incentives can bias toward "utilization" (billable hours) over "outcome" (hitting milestones).

Prana's Commitment: Outcomes over hours. We commit to delivery targets with governance to those targets. You pay for results, not utilization metrics.

The Problem: Inspection findings related to TMF completeness and document quality remain among the most common regulatory observations. Remediation is costly and time-consuming.

The Backlog Trap: TMF maintenance often falls behind during peak operational periods. By the time audits approach, teams scramble to reconcile months of accumulated gaps.

Prana's Discipline: Weekly QC cadence from day one. AI-assisted document routing and completeness checks keep your TMF inspection-ready at all times—not just before audits.