APICES Acknowledged for its Role in GEOCP-SEOR Study
Stage III NSCLC care sits at the intersection of multimodal treatment and real-world constraints. The GEOCP-SEOR population-based study describes how patients are managed across Spain, and APICES was acknowledged for supporting the publication through medical editorial assistance.
APICES Acknowledged for its Role in GEOCP-SEOR Study
APICES CRO is pleased to announce its contribution to the GEOCP-SEOR study. This is a RWE Study in Non Small Cell Lung Cancer (NSCLC), recently featured in the Cancers Journal.
The study evaluates and provide real-world insights into the management of non-small cell lung cancer stage III (NSCLC-SIII) in Spain.
APICES contributed to the study through medical editorial assistance. The work of Fernando Rico-Villademoros, and Juan Luis Sanz, along with the broader Spanish team, has been instrumental in the success of this project.
We also acknowledge AstraZeneca Spain and Paloma Sosa Fajardo for the collaboration and opportunity to contribute to this important study advancing treatment options in oncology.
Key Takeaways: First-in-human trials in the EU are governed by Regulation (EU) No 536/2014 and the EMA’s first-in-human guideline (EMEA/CHMP/SWP/28367/07 Rev 1). Sponsors must submit a complete Clinical Trial Application via the CTIS portal and obtain both Part I...
Key Takeaways: Phase I dose escalation design in the EU is governed by ICH E8(R1), EMA first-in-human guidance (EMA/CHMP/SWP/28367/07 Rev.1), and EU Clinical Trial Regulation 536/2014 via CTIS. The classical 3+3 design is increasingly replaced by model-based...
EU MDR clinical investigation requirements have fundamentally changed how Medtech sponsors plan and execute device studies in Europe. Regulation (EU) 2017/745 replaced the clinical investigation provisions of Directive 93/42/EEC (MDD) and introduced a more stringent, harmonised framework across all 27 EU member states. For sponsors running investigations in Spain, Germany, France, the Netherlands, or any other member state, understanding which pathway applies to their study is the single most consequential regulatory decision before CIP submission.