Background
Allucent was engaged by an emerging European biotech sponsor to complete an EU CTR submission before year-end 2023, in alignment with a critical corporate milestone. The engagement began in early November, without a final protocol or finalized submission package in place, leaving less than three weeks for full preparation and EU CTR submission.
Study Overview
Study Design: Non-randomized, open-label, Phase I/II study including a dose escalation phase followed by dose expansion
Indications: Relapsed/Refractory Peripheral T-cell Lymphoma
Geographic Scope: France and Italy (limited number of sites)
Services Provided: Full-service EU CTR submission support (Study Start-Up, Regulatory, and Medical Writing)
Challenge
This regulatory submission for a clinical trial was conducted under exceptionally compressed timelines, presenting significant operational and regulatory challenges. The final study protocol was not available until November 30, with essential documents, including the Investigator’s Brochure (IB), Investigational Medicinal Product Dossier (IMPD), and translated Informed Consent Forms (ICFs), only finalized in early to mid-December. The submission package required not only the integration of country- and site-specific content, but also intensive quality control, comprehensive redaction, and meticulous portal preparation. A critical success factor was the ability to obtain sponsor reviews within 24 hours, a necessity to prevent delays along the critical path.
Regulatory complexity added another layer of difficulty, involving trial-centric setup within the Clinical Trials Information System (CTIS), a GDPR-compliant redaction strategy, and cross-border coordination. Despite these pressures, document submission readiness had to be achieved for over 90% of materials by mid-December, with only limited flexibility for final updates thereafter, underscoring the high degree of precision, collaboration, and agility required throughout the process.
Solution
Faced with a highly complex and time-sensitive clinical trial submission, Allucent launched a risk-managed, fast-track approach rooted in deep expertise with EU Clinical Trials Regulation (CTR) processes. From the outset, Allucent’s cross-functional team facilitated accelerated planning and tight internal alignment between its Study Start-Up and Medical Writing teams, jointly identifying the shortest feasible timelines that would still uphold submission integrity. Transparent communication with the sponsor was a priority from day one, with Allucent providing a detailed checklist of required commitments and enforcing strict deadlines to ensure mutual accountability.
To maintain momentum, critical documents such as the Master and country-specific Informed Consent Forms (ICFs) and biological sample compliance forms were developed at risk, even before final protocol approval. This approach was made possible by Allucent’s regulatory expertise and experience executing EU CTR submissions under compressed timelines. Expedited translation workflows and predefined quality control checkpoints enabled rapid document readiness without compromising accuracy. In parallel, Allucent provided strategic guidance on CTIS portal setup, redaction policies focused strictly on mandatory data protection, and transparency requirements, streamlining the trial’s regulatory trajectory. A firm final document cut-off and redaction-readiness plan further ensured sufficient quality control and submission buffer. Together, these actions demonstrate Allucent’s nimble approach and ability to navigate complex clinical trial operations and regulatory submissions with focus and agility, even under significant pressure.
Outcome
Despite tight document delivery windows and initial constraints, the sponsor achieved its strategic objective of successfully submitting the EU CTR application by year-end 2023, less than three weeks after final protocol availability, with Allucent’s support
Key contributors to success included:
- Close collaboration and shared accountability between the sponsor and Allucent
- Allucent’s internal ownership and strong coordination across all departments
- Sponsor’s commitment to document readiness and rapid review cycles
- Allucent’s deep expertise in navigating the EU Clinical Trials Regulation ensured no compromise in quality or compliance
This case demonstrates how Allucent helps biotech sponsors meet critical milestones under pressure, providing the regulatory expertise and operational agility to navigate complex first-in-human study submissions, and serves as a trusted partner during pivotal phases of development.
Learn more about our Regulatory & Drug Development Consulting services, supporting early clinical development and regulatory submissions under EU CTR and other global frameworks.
Share This
