How a Global CRO Scaled to 500+ Annual Submissions with DnXT
Growth is the goal for every CRO. More sponsors, more programs, more submissions. But in regulatory operations, growth without the right infrastructure creates a specific and dangerous failure mode: quality variance. When you are publishing 200 submissions a year with a seasoned team, consistency is manageable. When you need to reach 500 submissions across 40+ sponsors, six regions, and a growing but less experienced workforce, consistency becomes your single biggest operational risk.
This is how one mid-size CRO navigated that transition.
The Starting Point: 200 Submissions and Growing Pains
The CRO had built a strong regulatory publishing practice serving over 40 sponsor companies. Their submissions spanned FDA, EMA, Health Canada, and TGA. The team was good. The processes were documented. The tools, however, were not keeping pace.
The operational challenges fell into four categories:
Sponsor document management was fragmented. Each sponsor had their own document management approach. Some used Veeva Vault. Others used SharePoint. Several relied on file shares with folder-based version control. The CRO’s publishing team spent significant time simply collecting, organizing, and verifying source documents before publishing could begin. Manual file transfers introduced version errors that were difficult to detect downstream.
The staffing model was not scaling. The CRO had historically assigned dedicated publishing specialists to each sponsor account. This ensured quality and continuity but made growth linear: more sponsors required proportionally more staff. Recruiting experienced eCTD publishing specialists was already difficult. The labor market was not going to solve this problem.
Quality was inconsistent across teams. Different publishing specialists had different habits. QC depth varied. Some teams caught hyperlink errors before submission; others did not. The CRO tracked technical rejection rates by team and saw meaningful variance—not because of skill differences, but because of tooling and process inconsistency. A desktop publishing tool used differently by 30 specialists will produce 30 slightly different quality outcomes.
Review workflows were ad hoc. Sponsor review of draft submissions happened via email, shared drives, and occasional screen-sharing calls. There was no centralized system for annotations, comments, or approval tracking. When a sponsor asked “where does our submission stand?” the answer required multiple emails to reconstruct.
The Platform Decision
The CRO’s leadership recognized that scaling to 500+ submissions per year required a platform, not more headcount. The requirements were specific:
- Multi-tenant architecture with strict sponsor isolation—no risk of cross-sponsor data exposure.
- Integration with Veeva Vault, since roughly half their sponsor base used it as their eDMS.
- Standardized review workflows that could be applied consistently across all sponsor programs.
- Batch processing capability to handle parallel submissions without queuing.
- Deployment speed measured in weeks, not quarters.
They selected DnXT’s platform: Publisher for eCTD compilation, rendering, and hyperlink automation; Reviewer for structured QC and sponsor-facing review workflows. The multi-tenant architecture was a decisive factor—each sponsor would exist in an isolated tenant, with dedicated encryption and access controls, managed from a single administrative interface.
Solving the Document Collection Problem
The most immediate operational improvement came from DnXT’s Veeva Vault integration. The platform supports bi-directional sync with Vault: inbound sync pulls approved documents into the publishing workspace, outbound sync pushes published outputs back to Vault, and full sync maintains ongoing alignment. The integration includes conflict detection—if a document is modified in Vault after it has been pulled into the publishing workspace, the system flags the conflict rather than silently using a stale version.
For the roughly 20 sponsors using Veeva Vault, this eliminated the manual file transfer process entirely. Documents flowed from the sponsor’s Vault instance into the CRO’s DnXT workspace automatically, with version integrity maintained end-to-end. Job management capabilities allowed the operations team to monitor sync status across all sponsor accounts from a single dashboard.
For sponsors using SharePoint, DnXT’s SharePoint integration provided similar connectivity. For the remaining sponsors on file shares, the platform’s import capabilities—including local upload, cloud import, and chunked upload with real-time progress tracking—standardized the ingestion process regardless of the source.
Standardizing Quality Across 40+ Sponsors
The CRO deployed DnXT Reviewer as the universal QC and review layer across all sponsor programs. This meant every submission, regardless of sponsor or publishing specialist, went through the same structured review process:
Hyperlink validation on every submission. DnXT Reviewer checks every hyperlink in the compiled eCTD—cross-document, cross-module, and external—and surfaces results in an accept/reject workflow with threaded replies. The publishing specialist resolves flagged links before the submission advances. This single automation reduced the CRO’s technical rejection rate from cross-link errors to near zero.
Chronology reports for every dossier. Reviewer’s AI-enriched Chronology Report generates a structured submission timeline for each dossier, giving both the CRO team and the sponsor a clear view of the regulatory history. For sponsors with complex filing histories across multiple regions, this replaced hours of manual timeline reconstruction.
Structured annotations and comments. Reviewer’s annotation tools—highlight, underline, strikethrough, and text annotations—replaced email-based feedback. Every annotation carries a full audit trail. Threaded comments with statistics gave project managers visibility into review progress without chasing individual reviewers for status.
Correspondence tracking. The Correspondence Report automatically tracked agency communications, applied AI classification, and extracted question-and-answer pairs. For sponsors managing ongoing FDA interactions across multiple sequences, this provided a single source of truth that previously existed only in scattered email threads.
Scaling Publishing Throughput
DnXT Publisher’s batch rendering pipeline allowed the CRO to process multiple submissions in parallel. Previously, their desktop tool could handle one rendering job at a time per workstation. During peak filing periods, submissions queued—and queuing meant missed timelines.
With DnXT Render’s batch pipeline, the CRO processed documents across sponsor programs simultaneously. Rendering accuracy held at 99%, with PDF/A failure rates below 1%. The AI Navigator’s automated hyperlink creation reduced the most labor-intensive step—manual cross-reference linking—from 20-30 hours to under 5 hours per submission. Across 500 submissions, that time savings alone was transformative.
Results After One Year
- Submission volume scaled from 200 to over 500 annually without a proportional increase in publishing headcount. The team grew by approximately 40%, not 150%.
- Quality consistency improved measurably. Technical rejection rates converged across teams as the standardized Reviewer workflow eliminated individual process variance. The CRO’s overall first-time acceptance rate exceeded 97%.
- Veeva Vault sync eliminated an estimated 15-20 hours per week of manual document collection, verification, and version reconciliation across the Vault-using sponsor base.
- Sponsor satisfaction scores increased. Sponsors cited two factors: visibility into submission status through the Reviewer dashboard, and faster turnaround times on review cycles.
- New sponsor onboarding dropped from 2-3 weeks to under one week. Provisioning a new tenant, configuring role-based access, and establishing Vault connectivity became a standardized, repeatable process rather than an infrastructure project.
The Structural Lesson
For CRO leadership evaluating how to scale regulatory operations, this case underscores a structural point: the constraint on growth is not talent availability or even sponsor demand. It is the degree to which your publishing and review infrastructure imposes per-sponsor overhead.
If every new sponsor requires dedicated staff, dedicated infrastructure, and a bespoke review process, your growth is linear and your margins compress with every account added. If your platform handles tenant isolation, document integration, and QC standardization at the architecture level, growth becomes a volume problem—and volume problems are solvable.
The CRO in this case did not replace their people. They replaced the per-sponsor manual work that was consuming those people’s time. The result was not just more submissions—it was more consistent submissions, delivered faster, with better sponsor visibility. That combination is how a CRO defends and grows its regulatory publishing business.
