Global Experts Convene in Bucharest to Advance Patient‑Centric Clinical Trials and EU Harmonisation
Bucharest, Romania – 14 November 2025 – The Bucharest International Clinical Trials Symposium (BICS) 2025 brought together leading regulators, researchers, industry executives and patient advocates to shape the future of clinical research. Now in its 17th year, the Clinical Trials Symposium is recognised as one of Europe’s leading forums for advancing harmonisation, innovation and patient‑centricity in clinical trials.
Hosted by the Avantyo Institute of Clinical Research, the symposium highlighted the urgent need to modernise trial design, reduce regulatory complexity and strengthen collaboration across borders.
“Clinical research must evolve to be more transparent, collaborative, and patient‑focused. BICS continues to serve as a vital forum for shaping this transformation,” said Dr. Cristina Florescu Moraid, President of BICS and Director of Avantyo Institute of Clinical Research.
• Key Themes from BICS 2025
EU Harmonisation & New Guidelines Regulators and experts unveiled the final (R3) version of the ICH GCP E6 Guideline, introducing a flexible, risk‑based, participant‑centred framework that integrates digital technologies and real‑world data.
• Patient‑Centricity in Practice
Panels highlighted barriers to patient participation – such as lack of accessible information and logistical challenges – and proposed solutions including digital enrolment platforms, decentralised trial models, and co‑design with patient organisations.
"Patients must be active partners, not passive participants,” said Rozalina Lăpădatu, President of the Autoimmune Patients Association (APAA).
• Strengthening Clinical Sites & Study Coordinators
Discussions underscored the critical role of study coordinators in ensuring trial quality and patient retention, calling for formal recognition of the profession and investment in site infrastructure.
• Collaboration Across Stakeholders
Industry leaders, investigators, and patient groups emphasised rebuilding trust through transparency, predictable processes, and stronger sponsor‑site‑patient partnerships.
“Rebuilding trust in clinical research depends on transparent sponsor–site–patient relationships, with clear communication, predictable processes and co‑designed studies that place patients at the centre,” said Dr Alina Codrescu, Director of Clinical Operations, Balkan Cluster, Bristol Myers Squibb.
Looking Ahead: IMPACT Conference 2026
Organisers announced the upcoming IMPACT Conference – Medical Innovation for Access and Treatment Collaboration, scheduled for April 2026 in Romania. Dedicated entirely to patients as active partners in clinical research, IMPACT will further advance the dialogue on patient‑centric innovation.
About BICS
The Bucharest International Clinical Trials Symposium (BICS) is one of Europe’s most important forums for clinical research and Romania’s leading symposium in the field, fostering collaboration among regulators, industry, academia and patient groups. Founded in 2008 as the Clinical Trials Symposium, it has been guided from the very beginning by Dr Cristina Florescu Moraid and proudly hosted under Avantyo’s leadership since 2019. Over its 17‑year history, BICS has championed modernisation and internationalisation of clinical trials, with a strong focus on patient‑centricity and EU harmonisation.
List of presentations:
Anca Brasoveanu
Catalina Sarbu
Darina Hrdlickova
Florin Petrutiu
George Tanaseanu
Leontina Voicea
Lia Chislari
Monique Denise Maria Al
Oana Clevet
Rebeca Gonzalez Vicedo
Sorin Visan
