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.
Complete guide to Phase I oncology trials in Western Europe in 2026: CTIS submissions, country selection (Spain, France, Germany, Netherlands), site criteria, study design, and CRO selection for biotech sponsors.
Advanced Therapy Medicinal Products (ATMPs) are transforming modern medicine, but clinical development remains highly complex. This article explores key challenges in ATMP clinical trials, recent FDA and EMA regulatory updates, real-world success and failure cases, and how biotech leaders can select the right CRO for these advanced therapies.
In this interview, Oscar Salamanca, CEO of APICES, shares how the integration has been implemented, how teams are supported through change, and what this means for current and future clients.
This article explores how Western and Eastern Europe compare as clinical trial destinations, and how CTIS is reshaping country selection. It reviews differences in regulatory processes, recruitment dynamics, site infrastructure, and costs, while highlighting a shift toward operational performance, patient access, and therapeutic expertise.
RWE and HEOR have moved from supporting inputs to decision-critical evidence across development and access. This article summarises what teams are using them for today, how evidence generation is changing, and where AI adds value when paired with the right governance.
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.
AI is already influencing how trials are designed, monitored and analysed, but adoption in Europe depends on clear validation, oversight and data governance. Óscar Salamanca (APICES, AECIC) shares where AI adds value today and what responsible implementation needs next.
ESMO Congress 2025 in Berlin highlighted how IO combinations, ADCs and biomarker-driven trials are reshaping development plans. This recap summarises the most relevant signals and what they imply for trial design, recruitment and operational planning in Europe.
The CANTABRICO phase IIIb single-arm trial reports on first-line durvalumab plus platinum-etoposide followed by durvalumab maintenance in extensive-stage SCLC. APICES was acknowledged for supporting study delivery, analysis, and publication activities.
Europe offers real opportunities for oncology trials, but start-up speed and delivery still vary by country and trial design. These seven CEO-level questions help you pressure-test feasibility, CTIS execution under the EU CTR, specialty approvals, and data and diagnostics readiness.
Advanced, pre-treated TNBC has limited options beyond standard chemotherapy. The PALBOBIN phase IB study evaluates binimetinib plus palbociclib in molecularly selected patients, and APICES was acknowledged for supporting key operational activities during the trial.
APICES has appointed Egle Pavyde as Vice President of Business Development. With more than 10 years in clinical trials and a scientific background in pharmacy and life sciences, she will focus on strengthening client engagement and supporting growth across markets.
Biotechs rarely struggle with one issue at a time. This article breaks down the most common clinical research challenges, from resourcing and flexibility to regulatory complexity and quality, and explains how APICES supports teams to stay on track through every trial stage.
How does first-line osimertinib perform for advanced EGFR-mutated NSCLC in routine care in Spain? The GGCP 081/21 retrospective study addresses effectiveness and safety in a real-world setting, and APICES was acknowledged for supporting analysis and publication activities.
