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BIOSpain 2025
Meet Veristat at BIOSpain, October 7 - 9, 2025
Veristat is excited to attend BIOSpain 2025, one of Europe’s largest...
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In oncology drug development, every day counts. Patients are waiting, trials are complex, and the stakes are high. Getting from clinical development to regulatory approval requires more than simply assembling documents—it demands speed, accuracy, and deep therapeutic insight.
Regulatory publishing is the critical bridge between clinical development and regulatory approval, ensuring every element of your application meets the exacting requirements of global health authorities.
Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to review 90% of standard NDAs and BLAs within 10 months of filing—and just 6 months for priority reviews. Innovative programs like the Real-Time Oncology Review (RTOR) program from the FDA offer the potential to bring life-saving therapies to patients even faster by streamlining key portions of the review process.
For sponsors, these opportunities mean that internal teams must be prepared to accelerate activities—data cleaning, analysis, and submission preparation—to fully capitalize on shortened review windows. Partnering with a CRO experienced in oncology publishing ensures that speed is achieved without sacrificing quality or compliance.
Reason 1: They Understand the Complexity of Oncology Submissions
In the last two years, Veristat has supported 13 oncology applications, each requiring careful coordination and precise messaging.
Why this matters:
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Oncology submissions often integrate large, multi-trial datasets and adaptive designs.
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Endpoints may involve biomarker-driven subpopulations and survival analyses that must be crystal clear for reviewers.
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An experienced CRO will structure ISS, ISE, and CSR documents so that they tell a unified, compelling story that highlights the most important efficacy and safety outcomes.
Reason 2: They Deliver Flexibility Without Compromise
Oncology timelines can shift quickly, and your CRO needs to adapt without cutting corners.
Example:
In a recent EMA oncology submission, Veristat:
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Implemented only essential bookmarking and hyperlinks
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Omitted document-level QC with well-conceived safeguards in place
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Achieved successful eCTD validation with zero technical rejections
“We adapted our submission strategy to meet guidance requirements while protecting data integrity. The result? The EMA accepted the submission with zero technical issues.” — Angie Gray, Manager, Global Regulatory Operations
Reason 3: They Bring Decades of Regulatory Publishing Experience
The best CROs offer both deep historical knowledge and cutting-edge technical capability. Veristat’s team averages 25 years of hands-on experience and is at the forefront of evolving publishing standards, including participation in the EMA eCTD 4.0 Technical Pilot Program.
What this means for sponsors:
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Early insights into changing requirements to avoid last-minute delays
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Smarter submission strategies informed by direct regulator engagement
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Stronger agency trust built on a consistent track record of high-quality submissions
The Oncology Publishing Process — Your CRO Should Seamlessly Guide You Through:
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Early Planning – Define submission timelines, roles, and regulatory strategy from the outset.
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A Defined Submission Strategy – Align document strategy with regional guidance and technical requirements.
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Document Preparation & Shells – Initiate early drafting with harmonized messaging across modules.
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Regulatory Publishing Plan – Establish bookmarks, hyperlinks, and eCTD structure based on submission needs.
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QC & Compliance Checks – Tailor quality review based on risk, timeline, and agency standards.
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Electronic Publishing (eCTD) – Compile and validate technical packages for regulatory portals.
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Submission to Agencies – Deliver fully compliant applications to FDA, EMA, MHRA, and others.
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Post-Submission Support – Respond to regulatory queries and manage updates or variations.
Partner with Veristat
Choosing a CRO that understands the complexity, urgency, and nuance of oncology submissions could be the difference between meeting your milestones or missing them. Let Veristat help you publish with confidence. Visit veristat.com to learn more.
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