Prepared, cohesive and diverse team

Dr. Josep Rodés-Cabau is a cardiologist with more than 25 years of clinical experience and a strong academic track record. For the past 20 years, he has been working at the Quebec Heart & Lung Institute (Quebec, Canada), which represents the largest institution in cardiology and cardiac surgery in Canada, and is also currently the director of Research and Innovation at the Clìnic Barcelona (Barcelona, Spain), and professor of Medicine at the Laval University (Quebec, Canada). He has developed an extensive research and innovation program in the field of interventional cardiology, with special interest in structural heart disease. He has a large experience in clinical trials, has published more than 700 articles in peer-reviewed journals, and is considered a key opinion leader in the field (H index: 113). 

Xavier is a medical doctor, currently Independent Consultant on drugs and medical devices development and regulation since September 2023.

He was the founder and CEO at Drug Development and Regulation (DDR), a consulting company based in Barcelona, London and Amsterdam and, additionally, he sponsored a unique Business Center for biotechnology and health related companies and entrepreneurs in Barcelona (Support Business Center).

DDR was acquired by Veristat in October 2021 and Xavier became the Vice-President Regulatory Affairs Europe at Veristat until his partial retirement in September 2023.

He was Head of Safety and Efficacy at the European Medicines Agency (EMA) during 2005-2012, and previously held leadership positions in the biopharmaceutical industry for more than eighteen years, covering international clinical development, pharmacovigilance, biostatistics and medical affairs. In addition to Xavier’s specialty in internal medicine, pharmaceutical medicine and biostatistics, he has developed expertise in several specific therapeutic areas and carried out postgraduate qualification in clinical pharmacology, drug development and regulation (Tufts University School of Medicine, Boston). He is a recognized expert on regulatory systems and procedures and benefit-risk assessment. He is professor and invited lecturer in various academic institutions in USA and Europe and he has been extensively involved setting up strategy, design and operations of drug development programs and post-marketing drug surveillance, as well as on portfolio management and in-and-out licensing opportunities. As independent consultant he provides strategic and hand-on support for regulatory plans and activities in Europe and has set up an experts' network through preferential high quality collaborations covering Europe, USA, Latin America and Japan.

Dr. Laura Oleaga is the head of the Radiology Service at the Hospital Clínic de Barcelona and a researcher in the Diagnostic and Therapeutic Group in Oncology at IDIBAPS. In addition, she is also an associate professor of Radiology at the Faculty of Medicine and Health Sciences of the UB. Her career stands out for a special dedication to research, but above all to training and teaching, since she has actively participated in training programs for residents and in multiple courses dedicated to education.

With over two decades of expertise in clinical research and project management, Sole is specialized in steering complex clinical trials to success. her career journey has been marked by progressively responsible roles in renowned organizations, where she polished her skills in managing diverse therapeutic areas and leading cross-functional teams.

Her extensive experience spans various phases and indications, from pivotal Phase 3 trials in infectious diseases like COVID-19 and pneumococcal infection to niche studies in rare diseases. She has demonstrated proficiency in therapeutic areas like endocrinology, cardiology, and oncology, showcasing adaptability and a deep understanding of diverse medical landscapes.

During her recent role as a Senior Clinical Project Manager, she's been all about crafting super-detailed project plans to ensure compliance with regulatory standards and coordinating trials execution. She’s particularly skilled at encouraging teamwork amongamong stakeholders, spanning from investigators to sponsors and vendors, ensuring the efficient attainment of project milestones.

Daniel holds an MSc in Biomedical Engineering from the Universitat de Barcelona and after graduating he immediately joined industry conducting regulatory activities that ranged from the development of new devices to granting access to market. He joined Hospital Clinic de Barcelona, where he created the Medical Device Unit in charge of compliance of regulatory activities of medical devices within the Hospital. He has a wide expertise that includes developing and implementing regulatory strategies, preparing regulatory submissions and working closely with cross-functional teams to ensure timely product approvals. 

Eliana is a biotechnologist with over 8 years of expertise in the Clinical Research field. She has held pivotal roles within this industry such as Clinical Research Associate, CRA Line Manager, and Clinical Lead. She has joined BCCC where she is currently leading as Head of the Monitoring department, where she coordinates the clinical research associates and clinical study managers. Eliana has contributed to diverse therapeutic areas including oncology, diabetes, dermatology, respiratory, and has also worked in pediatric studies, primarily focusing on phase II and III trials. She possesses in-depth experience and leadership skills and has led multiple teams during her career, both inside and outside the clinical research landscape, which make her a valuable asset in the industry.

Eulàlia has a degree in Pharmacy from the University of Barcelona and a Master's degree in clinical trials.

She has over 15 years of experience in the clinical research industry managing projects in different therapeutic indications and patient populations including paediatric studies. She has experience in clinical trials as well as in non-interventional studies since the study start-up activities, throughout the course of the study and up to the closure of the project. Eulàlia has extensive experience in managing large projects in direct collaboration with multidisciplinary teams based in Europe and US.

Vicenç is monitoring manager at Món Clínic and Senior Freelance CRA and Manager of FREECRA, S.L. He is a specialist in CRA, Audits of medical device and pharm studies and Clinical Trial Liaison. His professional career has been based in the Pharmaceutical Industry, having worked in Clinical Research Organizations, BAYER, Syntex Latino and Almirall Laboratories.

He is currently responsible for the coordination and the start and follow-up of the clinical trials developed in Spain. I maintain close contact with the sponsors about the timelines and characteristics of the trials. Each project has its own difficulty, therefore it is essential to have a good planning and to work closely with a well motivated team. To solve the difficulties and get the best results (which are not always possible) we combine our knowledge and work closely together. To maintain a high quality of work and good results you have to make sure that the team (team members) is (are) trained continuously.

Almudena is a veterinarian who has more than 20 years of experience in clinical trials, working for CROs, academia and as freelance consultant in different roles.  
She has developed a broad experience in clinical research as clinical trial manager, project manager and trial monitor in international clinical trials with drugs and vaccines as well as control human model infection studies in Europe and in different African countries. 

Salvador was also a founding partner of Saalig Clinical, SL, CRO established in 2005 and closed in spring 2022 that was focused on Study Design, Data Management and Statistics.

His experience goes through another CRO (RDES SL), from 1999 to 2004, and a PhD in Pharmacy (1994), a master's in biotechnology (1993) and another in Pharmacoepidemiology (2007). 

He is also an associate professor in the Department of Pharmacology at the University of Barcelona since 2008 and a professor in the master's degree in clinical Trial Monitoring of the Official College of Physicians of Barcelona since 2005.  

Salvador's professional interests: Decision support systems and Artificial Intelligence indications in therapeutics.

Marco has been working as a data analyst for about 30 years. He has gained expertise in several fields, including the analysis of epidemiological data, pharmaco-epidemiology and drug safety, the statistical design of clinical trials, and the regulatory aspects of clinical research. He has a degree in Philosophy of Science from the Università Statale di Milano (1991) and an MSc in Applied Statistics from Sheffield Hallam University (Sheffield, England, 1999). He worked as a statistician and data analyst in Academic Institutions (Barcelona Municipal Institute for Medical Research (IMIM),  1994-2000 and European Consortium for the study of Chronic Liver Failure, 2008-2020), as well as a project statistician, statistics manager or data analyst for Pharma Companies and CROs (Almirall,  Novartis Pharma, Parexel or Cytel). Marco’s main areas of expertise include the design and methodology of clinical studies, the regulatory issues in the statistical analysis of clinical trials, and the application of statistical techniques to medical research, particularly survival analysis methods.

Dr. Joan Valls (MSc Statistics, MPH, PhD Medicine) is an epidemiologist and statistician with more than 20 years of experience in medical research projects in public institutions.

During these years, he has been working as a medical statistician and epidemiologist at the Consulting Service of the Autonomous University of Barcelona (Spain), at the Catalan Institute of Oncology (Spain) and at the Biomedical Research Institute of Lleida (Spain), where he served as the Director of the Biostatistics & Epidemiology Unit. He has also been teaching Statistics and Epidemiology at the Autonomous University of Barcelona (Spain) for more than 20 years and has undergone two international research stages at DECISA (Paris, France) and at the Finnish Cancer Registry (Helsinki, Finland). In 2021, he joined the International Agency for Research on Cancer (World Health Organisation, France) as a scientist, focusing his research on cervical cancer epidemiology with particular attention to its prevention, especially in lower and middle-income countries. 

During his research career, he has co-authored more than 80 articles in peer-reviewed journals with an average impact factor of 5.7 and has participated in several competitive research projects.

Sagar holds an Bachelor degree in Pharmaceutical Science from Pune University, India and a Master degree in Clinical Research and Regulatory Affairs from Sikkim Manipal University, India. He has over 13 years of rich experience in core Clinical Data Management (CDM) spanning all phases (I-IV) of clinical research which includes all aspects of CDM field from CRF design through database lock. He has experience of working on Vaccine and Drug trials. Previously he has been associated with Cognizant, Novartis, AstraZeneca and Saama. He led multiples CDM studies and successfully delivered it.

Carla has studied biotechnology, and is about to finish her master's degree in Omics Data Analysis at the University of Vic.
She has been working for Hipra, the vaccine pharmaceutical laboratory, at the documentation department, programming the plant control of the vaccine processes.

Ainhoa holds a Bachelor degree in Biology from Basque Country University, and a Master’s Degree in Bioinformatics for Health Sciences from University of A Coruña. She has been working at CITIC (Centre for Information and Communications Technology Research) creating Open Data applications and managing a project, promoted by the FECYT, whose objective was to awaken STEM vocations among young people and raise awareness of the reality of cerebral palsy.

Noemí has developed most of her professional career at the Clínic Barcelona Hospital, where she has worked since 2006 in the research area. She is a coordinator and monitor of clinical trials in the specialties of Cardiology, Pulmonology, Vascular, Allergies and Hematology. She has also worked in the healthcare field (ICU and hospitalization wards) in the Cardiology Unit of the Clinical Hospital. She completed her Diploma in Nursing training (Ramón LLull University) with a course in Clinical Trial Coordination, a postgraduate degree in Cardiology, Pulmonology and Oncology and a master's degree in Intensive Care Unit (University of Barcelona). She has also completed a patient information course, one of good clinical practices, she has knowledge of the IVRS system and the management of electronic data collection notebooks.

Jandro is a dedicated clinical research professional with over 6 years of experience in oncology and other therapeutic areas. He has successfully managed more than 50 clinical trials across phases I, II, and III, encompassing both interventional and observational studies.

His life experiences have cultivated a profound commitment to improving patient quality of life and life expectancy while upholding strict adherence to GCP standards, healthcare ethics, and data integrity.

With a deep understanding of clinical research and site management, Jandro excels in the end-to-end coordination of studies, from initial stages to completion. He has demonstrated effective team leadership skills, but his true passion lies in mentoring his peers and supporting their professional development.

Júlia is a Dietitian who has always been in contact with the research. She hold more than 3 years of experience in clinical trials working as a Study Coordinator at Sant Joan Hospital in diferent therapeutic areas such as cardiology, metabolism,surgery, pneumology and radiotherapy.

Now, she's boosting her career as Clinical Trial Assistant.  

Anna is graduated in Nursing and she has been study coordinator and study nurse at Sant Joan Hospital during 8 years. Performing coordinating tasks in Clinical trials from the opening to the closing visits, coordinating patients, files and IMP.

Recently she has been forming herself as CTA and Clinical trial monitoring looking for a growup in her career.

Judit has over 7 years of experience as a clinical trial coordinator, overseeing trials ranging from phase I to III across various medical fields such as hematology, endocrinology, neurology, cardiology, oncology, dermatology, and immunology, including pediatric studies.

Judit's responsibilities include managing all aspects of trial coordination, from its inception to completion, performing nursing duties for the study, supervising participant recruitment and safety, collecting and organizing data, ensuring adherence to regulatory requirements, and facilitating communication among participants and research team members.