Sponsors Report Juggling up to Five Vendors and Four Phase II-III protocol Amendments Per Trial, Fueling Demand for AI-driven Automation
BOSTON, Aug. 17, 2026 /PRNewswire/ —Â PhaseV, a leader in AI/ML for clinical development, today announced the findings of a new independent industry survey revealing that persistent operational bottlenecks cause million-dollar pre / post-trial financial burdens and months of delays across the biopharmaceutical industry. Notably, the data shows that external workflow spend accumulates to over $3 million across a program’s lifecycle as vendor expenditures surge from Phase I to Phase III among large biotech and pharma companies. Moreover, 88% of sponsors spend five weeks or longer managing critical-path statistical programming and reporting.
The report, The State of Clinical Trial Data Handoffs: Spend, Timelines, and Vendor Dynamics, commissioned by PhaseV, gathered insights from more than 50 senior executives at leading global pharmaceutical and biotechnology companies across clinical operations, biostatistics, statistical programming and regulatory affairs. The findings highlight the exorbitant cost in time and resources required to move studies from protocol development through submission, highlighting an urgent need for greater automation across the clinical trial lifecycle.
Among the key findings:
- Pre-Trial Delays: More than half (51%) of sponsors reported that pre-trial activities, including developing study synopses, protocols, schedules of assessments (SOAs) and case report forms (CRFs), typically take five to eight weeks.
- The Reporting Bottleneck: Operational challenges persist throughout study execution and reporting. More than three-quarters of respondents face prolonged timelines during late-stage documentation: one-third (33%) of respondents said developing statistical analysis plans (SAPs), SDTM datasets, ADaM datasets, tables, listings and figures (TLFs) and clinical study reports (CSRs) requires nine to twelve weeks, while an additional 43% reported these critical path activities take five to eight weeks.
- Compounding Costs & Complexity: Sponsors reported having to complete an average of four protocol amendments during a typical Phase II or III clinical trial, adding significant operational complexity, delaying timelines and increasing costs. As trials progress, out-of-pocket vendor spending rises substantially, with median post-trial workflow spending among large biotech and pharma respondents increasing from approximately $250,000 in Phase I to $900,000 in Phase III.
- Vendor Fragmentation: Compounding these delays, the survey found that 76% of sponsors are utilizing up to three vendors per trial across these workflows, and 12% are forced to manage four to five vendors, creating highly fragmented, manual handoffs that stall trial progress.
Collectively, the findings point to an industry still dependent on fragmented, manual workflows at a time when sponsors are under increasing pressure to improve R&D efficiency, reduce costs and accelerate the delivery of new therapies to patients. With industry estimates placing the cost of trial delays between $600,000 and $8 million per day in lost opportunity value, multi-week reporting bottlenecks represent a critical economic vulnerability.
“When late-stage reporting can stretch to three months and teams are stuck juggling multiple vendors just to cross the finish line, the clinical development model is clearly broken,” said Raviv Pryluk, PhD, CEO and Co-founder of PhaseV. “We built AI Conductor to replace these disconnected vendor handoffs with a single, integrated platform. By connecting protocol writing, statistical analysis, and regulatory submissions in one place, we turn multi-week bottlenecks into a matter of hours, eliminating the manual drag and getting therapies to patients much faster.”
AI Conductor applies PhaseV’s proprietary causal AI and machine learning technology to automate trial documentation and statistical programming from protocol through regulatory submission. Rather than relying on static templates and disconnected systems, the platform dynamically generates protocols, SAPs, ADaM and SDTM datasets, TLFs and other submission-ready assets while maintaining strict, audit-ready alignment across every document and stakeholder. By replacing manual, sequential workflows with a connected, AI-driven process, AI Conductor enables sponsors to accelerate study execution while improving data quality, consistency and regulatory readiness.
Click here to download the full report.
To learn more about how AI Conductor streamlines clinical development workflows or to request a demo, visit https://ai-conductor.phasevtrials.com/ or contact [email protected].
About PhaseV
PhaseV is a Boston-based technology company transforming clinical development through a Causal AI-powered decision-support platform. The solution integrates an optimization layer spanning trial design, response analysis, clinical operations, and portfolio strategy with an automation layer, AI Conductor, that streamlines statistical programming and pre-trial documentation. This end-to-end approach enables sponsors to accelerate timelines, de-risk trials, and enhance overall portfolio efficiency.
In just over three years, PhaseV has supported 80+ clinical trials for more than 50 global sponsors, including 8 of the top 20 pharmaceutical companies. Augmented by a data lake of 10 million+ patient-level records, the platform has helped sponsors reduce development costs by up to 50%, shorten trial durations by up to 40% and increase probability of success (PoS) by more than 30%. PhaseV is committed to driving faster, data-driven insights across the entire clinical development lifecycle. Learn more at www.PhaseVTrials.com and follow us on LinkedIn.
Media Contact:
Ellie Hanson
FINN Partners for PhaseV
[email protected]
View original content:SOURCE PhaseV
