On Schedule CTIS Approval for US Biotech - GMP Issues Resolved
Clinical Trials Application (CTIS) - Proactive Management, Timely Approval
Context
An American biotechnology firm developing a therapy for phase II study in kidney disease needed support with their clinical trial application in the EU’s Clinical Trial Information System (CTIS).
The sponsor had little experience with the Clinical Trials Regulation (EU) 2014/536 and CTIS. They were particularly concerned by the redaction requirements. Furthermore, after a document review by Lumis’ regulatory expert, discrepancies in the Good Manufacturing Practice (GMP) documentation were identified which risked delays to the approval timelines.
Lumis' solution
Lumis’ solution was based on the following three pillars:
- Education & Communication: The client was informed of the submission process and redaction requirements during the kick-off meeting. This educational process ensured the client were more aware of the requirements and helped them understand Lumis’ submission
approach. - Redaction: A redaction guideline was prepared with the client. All redacted documents were separately reviewed by the sponsor – ensuring a high accuracy of redaction.
- Manufacturing Documentation: This was addressed in two parts. A Note to File provided a simple solution to the study’s placebo IMPD documentation. Whereas, Lumis’ had to coordinate a multidisciplinary team to resolve a QP query.
Result
Why this matters to sponsors
Timely regulatory and ethics approvals is crucial for a swift study start-up. Taking time to fully understand the European regulations and local national requirements can promote a smooth submission. Complications can arise in the submissions process. Solutions can be simple, however, sometimes a multi-disciplinary effort is needed, which emphasises the importance of an experienced team.
