PhaseV Survey Says 88 Percent of Sponsors Face Trial Reporting Delays

PhaseV announced in a press release results from an independent survey showing that 88% of biopharma sponsors spend five weeks or longer managing critical path statistical programming and reporting workflows.

The survey covered more than 50 senior executives in clinical operations, biostatistics, statistical programming, and regulatory affairs. PhaseV said 51% of sponsors reported that pre trial tasks such as study synopses, protocols, schedules of assessments, and case report forms typically take five to eight weeks.

For reporting work, 33% of respondents said statistical analysis plans, SDTM datasets, ADaM datasets, tables, listings, figures, and clinical study reports take nine to twelve weeks. Another 43% said those tasks take five to eight weeks. Sponsors also reported an average of four protocol amendments during a typical Phase II or Phase III trial.

The company said 76% of sponsors use up to three vendors per trial for these workflows, while 12% manage four to five vendors. PhaseV also described AI Conductor, its platform for generating trial documents, statistical analysis plans, datasets, tables, listings, figures, and other regulatory submission materials.