Most pharma clinical operations run on a patchwork of CTMS, EDC, eTMF, Safety, RTSM, and eCOA systems bought at different times from different vendors. Teams spend hours reconciling data between them, re-entering the same information, and building reports by hand. Nobody has a single view of study progress, so problems surface late.
Most clinical leaders already know this costs them. The harder part is proving it: showing finance, IT, and leadership exactly what fragmentation costs today and what unification would return, in numbers they trust.
| Number | What it means |
|---|---|
| 40% | Reduction in study start-up time for an oncology-focused biotech after unifying CTMS, EDC, and eTMF |
| 50% | Decrease in protocol deviation incidents at the same company |
| 25% | Faster interim analysis delivery for a large sponsor running trials in 30+ countries |
| $500K–$1M | Potential annual savings from eliminating redundant licenses and integration maintenance (sample ROI model) |
| 20–30% | Potential reduction in FTE hours through automated scheduling, site activation, and eTMF filing |
| 7 days → 2 days | Average query resolution time in the sample ROI model |
| 6–12 months | When a well-implemented platform typically starts showing measurable improvements |
ICH E6(R3) puts more weight on risk-based oversight, data integrity, and traceability, which is hard to show when your data lives in six systems. At the same time, trials are getting more complex, more global, and more decentralized, and every delay pushes back patient access and revenue. Budgets are tight, so investments need hard numbers behind them. This whitepaper gives you the framework to measure where you are and make the case for where you need to be.
Build the business case for unification, with real numbers. Get the metrics framework, benchmarks, and sample ROI model.