RealTime Reports

eRegulatory adoption is strong, but not universal.
Over 83% of respondents are now using an eRegulatory or document management system, showing substantial progress in digitization. However, 17% remain paper-based, signaling continued opportunity – and need- for digital transformation across the industry.

Efficiency, not just compliance, is driving adoption. 
When asked why they adopted eReg/eISF, 93% cited improved efficiency as a top driver, surpassing even regulatory compliance. This indicates a shift in mindset, where sites now view eReg as a performance enabler, not just a compliance tool.

High staff workload and communication friction persist.
Tasks like document preparation, correspondence, and signature collection remain time-intensive. For example, over 22% of respondents said it takes more than 20 interactions to secure a single document signature, revealing a critical need for workflow automation and eSignature adoption.

Internal standardization is gaining ground.
Roughly 69% of sites now use a standardized internal regulatory file structure across all trials, a sign of increasing operational maturity. Those with robust eReg/eISF platforms appear better positioned to scale and train efficiently.

Reimbursement for regulatory costs remains inconsistent.
While 67% of respondents say they seek reimbursement for regulatory costs, only 32.56% recover more than 75% of those costs. Additionally, 22% are unsure if their site seeks reimbursement at all, suggesting a disconnect between regulatory work and financial strategy.

Sponsor demands are driving regulatory burden.
The top contributors to rising regulatory workload were increased variation in sponsor requirements and growing site responsibilities. Only 6% cited reporting requirements as a key burden, showing that sponsor complexity may outweigh regulatory complexity in daily operations.

Long-term archiving and document volume vary widely.
Over 30% of respondents outsource 76–100% of their document archiving, while 26% do not outsource at all. Regulatory documents typically represent 25–50% of total storage, highlighting their significant footprint and reinforcing the need for centralized, scalable eReg/eISF solutions.