Measured Outcomes Across 50+ Regulatory Submissions
Performance metrics validated across 20+ pharmaceutical companies, 12 therapeutic areas, and multiple regulatory authorities.
Faster
Evaluation timelines reduced vs traditional BRA
Methodology
Time-to-completion comparison across 50+ engagements. Measured from project initiation to submission-ready deliverable. Traditional methods benchmark: 12-18 months via CRO-led BRA. ArcaScience median: 5-7 weeks for equivalent scope.
More Insights
Clinically relevant signals identified vs manual review
Methodology
Insight density comparison per document. Measured as number of clinically actionable findings (adverse event patterns, drug-drug interactions, subpopulation risks) per 1,000 pages of source literature. Validated by independent medical review.
Cost Reduction
Platform subscription vs CRO-led BRA of equivalent scope
Methodology
Total cost comparison including internal FTE allocation. CRO benchmark: $250K-$500K per comprehensive BRA engagement. ArcaScience: Annual platform subscription + 0.5 FTE internal scientist. Amortized across typical 4-6 analyses per year.
DDI Detection
Drug-drug interaction detection improvement
Methodology
Comparative evaluation on same compound sets. Test set: 50 compounds with known DDI profiles from FDA labeling and published literature. ArcaScience models identify 3x more pharmacokinetic and pharmacodynamic interactions vs keyword-based manual search methods.
Submissions
Regulatory submissions accepted by FDA, EMA, PMDA
Acceptance Rate
100% acceptance rate. Zero major deficiency queries related to benefit-risk methodology or evidence synthesis. Submissions include CTD 2.5, PSUR/PBRER, RMP, and advisory committee briefing documents. Span 12 therapeutic areas and 3 regulatory authorities.
Clients
Blue-chip pharmaceutical companies
Competitive Win Rate
100% win rate vs traditional consulting in head-to-head evaluations. Clients include 8 of top 20 global pharmaceutical companies by revenue, plus specialty biotech and CRO partners. Average engagement duration: 3+ years, demonstrating platform stickiness.
Return on Investment
Typical payback period: 6-12 months based on PSUR cycle time reduction and CRO cost displacement.
Cost Avoidance
- ✓ CRO BRA engagement fees: $250K-$500K per analysis
- ✓ Internal FTE reallocation: 1.5 FTE freed per year
- ✓ Regulatory query reduction: fewer review cycles
Value Creation
- ✓ Accelerated time to market: 3-6 months earlier
- ✓ Enhanced safety signal detection: risk mitigation
- ✓ Portfolio-wide consistency: standardized methodology
Example ROI: Mid-size pharmaceutical company with 4 BRA requirements per year. Traditional CRO cost: $1.6M annually. ArcaScience platform subscription + 0.5 FTE internal support: $480K annually. Net savings: $1.12M per year (70% cost reduction) with 60% faster delivery timelines.
How Metrics Are Validated
Independent Review
All performance claims validated by independent third-party review. Client-reported outcomes verified through documented submission timelines and regulatory correspondence.
Controlled Comparisons
Benchmarks established through side-by-side testing on identical datasets. Manual review performed by qualified pharmacovigilance professionals following standard operating procedures.
Regulatory Evidence
Submission acceptance rates tracked through FDA, EMA, and PMDA correspondence. Deficiency query analysis confirms methodology robustness and regulatory alignment.