WE COMBINE THE ADVANTAGES
OF LARGE AND SMALL TO MIDSIZE CROS.
Audrius Sveikata (MD, PhD)
Audrius Sveikata (MD, PhD) has over 16 years experience in clinical research, regulatory sciences and academia, being in executive management positions in different operational roles within national competent authorities, academia, pharmaceutical industry and associations. His expertise includes the design and implementation of clinical development plans and regulatory strategies in European Union. Prior to CRO business, Audrius was head of the clinical assessors unit in State Medicines Control Agency at the Ministry of Health of Lithuania. His responsibility includes as scientific evaluation of non-clinical and clinical data of the medicinal product applications and as well as management of the administrative and procedural aspects of the evaluation of the applications submitted for marketing authorization in the country and Europe. As a professor of pharmacology at the University of Health Sciences (Lithuania), Audrius was involved in the teaching and scientific process with the specialization in neuro-psychopharmacology. He is active as a lecturer in various pharmacological, clinical research and life science conferences, author and co-author of more than 50 scientific publications. Within AICROS he is responsible for the countries as follows: Poland, Lithuania, Latvia, Estonia, Russia, Belarus, Ukraine and Georgia. The scope of his functions ranging from General Management (Human Resources, finance, administration) to management of clinical operations, regulatory consulting, pharmacovigilance, project management and business development. Audrius also is a president of Lithuanian Good Clinical and Regulatory Practice Association and member of several professional organizations.
Andreas Grund (MSc, PhD)
Andreas Grund (MSc, PhD) works since 1997 in the clinical research area. He worked in different positions in the areas Clinical Monitoring, Quality Assurance, Project Management and Training for the University Kiel, midsize and global CROs. He provides clinical research services for phase I to IV drug studies and medical device studies within Europe and USA. Within AICROS he is responsible for the countries Germany, Austria, Switzerland, France, Belgium, the Netherlands and UK. He developed a critical view for inefficient processes in clinical studies why he invented in 2009 an online based quality risk management tool (QCTMS) which includes eCRF, eTMF and IWRS. By using QCTMS AICROS is able to streamline traditional quality control processes to reduce costs and improve quality of multicentre trials. Since 2013 Andreas is President of AICROS.
Anne Blanchard (CCRA)
Anne Blanchard (CCRA) is CEO and Director of Clinical Operations for a regional Contract Research Organization operating in Latin America, leading numerous projects ongoing in Argentina, Brazil, Chile, Mexico and Colombia since November 2008. She began her career in Clinical Research in 1997, when she worked for a multi-national CRO in Argentina. Since then Anne has been involved in Clinical Monitoring and Management for both the Biopharmaceutical & Medical Device Industry and Academic Based Research. Anne studied Biology at the University of Buenos Aires and completed her postgraduate in Monitoring of Clinical Trials and in Clinical Research in the AMA (Argentine Medical Association) in 2001. Internationally ICH certified as CRA by ACRP in 2004, and presently Item Writer for the CCRA exam, Anne is also Editor of the Barnett International "GCP Question and Answer Guide" (Section for Latin America) yearly since 2012. Anne has authored several articles in publications such as "The Monitor" and "GCP Journal", presented in several international conferences and also hosted webinars related to the implementation of Clinical Research studies, regulations and oversight for compliance in Latin America. In 2015 she won the Outstanding Leadership in Clinical Research as a CRA Award by ACRP. Within AICROS she is responsible to cover Latin America.
Jiri Paseka (MD)
Jiri Paseka (MD) joined pharmaceutical industry in 1999 after having worked in OB/GYN Department of Masaryk University, Brno, Czech Republic. He gained his clinical research as well as general management experience in Janssen-Cilag, a pharmaceutical division of Johnson and Johnson, and later within DUX Consulting, a mid-sized Czech CRO, where he acted as Head of Clinical Operation and later also as Country Manager in Slovakia. Within AICROS he is responsible for the countries Czech Republic, Slovakia and Hungary. He is also a lecturer and consultant in the field of clinical research and runs educational programs in the same field within LCR. He is a co-author of the textbook "Monitoring, audit and inspection of clinical trials" and member of the board of Czech Association of Pharmaceutical Medicine. Since 2013 he serves as Vice-President of AICROS.
Rocío García Cañamaque (PhD) / Alfonso García Cañamaque (HRe, MBA)
Rocío García Cañamaque (PhD) got her Pharmacy Degree, Major in Biochemistry (Complutense University of Madrid), Spain, in 1997 and she started to working on clinical research in 2000, when she graduated from her Master Program for Clinical Research Associate, accredited by the Ministry of Health of Spain, and trained in Pharmaceutical Marketing and Clinical Trial European Regulations. She occupied responsibility positions in the Operations Field of several local and global CROs where she completed her preparation, and from where she got her organizational skills, her discipline, tenacity, and other abilities that leads her to the creation of her own company in Oct 2007. As an entrepreneur woman, during her business career she has had to break down many barriers and stereotypes. She joined AICROS in 2013 to be the responsible of the operations area in Southern Europe.
Alfonso García Cañamaque (HRe, MBA) studied Psychology in the Universidad Complutense de Madrid in the Human Resources Specialism, and finally joined the pharmaceutical research industry in 2009, after being in managerial and executive positions for over 10 years in different human resources and training related industries, where he developed his Marketing, Business Development and Project Management skills. Since then he has been trained and involved in drug, medical devices and food related studies and clinical trials, in the design, management, development and implementation areas for Spain, Portugal and Italy, regions under his responsibility within AICROS. He joined AICROS project in 2013, to boost the development of the research industry in Southern Europe and support on the development and performance of the marketing and social media strategy.
Noga Brunicki has over 13 years of experience within the Israeli pharmaceutical, medical device, life science and health care industry. Having a deep and well established know-how she is responsible for reliably and efficiently supporting phase I-IV studies in multiple therapeutic areas, both for medical device and medicinal products. Her expertise include the entire scope from the early design and set-up of study plans through monitoring and management and up to wrapping up and reporting the results. Noga had gained remarkable experience working for GlaxoSmithKline (GSK) in Israel were she was exposed to a very high level, state of the art, clinical research aspects in a global team environment. Since 2008 Noga works in the CRO business providing services to a wide variety of companies while keeping the ability to custom design a strategy that will fit to each one of them based on their individual needs. Using her long term strategic relationship with the Israeli sites, she bring the clinical study to be almost integrated into the clinical routine. Her academic solid ground is due to graduating both privileged institutions in Israel: Weizmann institute of science (Rehovot) as well as Israel's Institute of Technology (Technion, Haifa). Within AICROS she is responsible to cover Israel as well as business development activities.
Andrei Stoicescu (MD, MBA)
Andrei Stoicescu (MD, MBA) has over 15 years experience in life sciences, being in executive management positions in different operational roles within international pharmaceutical companies and having an extensive expertise in different therapeutic areas. After his University Degree in Odontology he joined Glaxo Wellcome Romania, managing the sales department, later he was appointed by Boehringer Ingelheim where he held different management positions in field force and business development, finally holding the position of General Manager at the Romanian Operative unit of Boehringer Ingelheim. Since 2009 Andrei works in the CRO business providing clinical research services to pharmaceutical, biotechnology and medical device companies. Within AICROS he is responsible for the countries Romania, Bulgaria, Moldova and Serbia, industry. As of 2013 Andrei is treasurer of AICROS. Within these positions, Andrei gained invaluable international experience within a multitude of areas including training & development, people management, business development and strategic account management.
Hiroshi Tsujimoto (MA)
Hiroshi Tsujimoto (MA) has over 30 years of experience in the clinical research field. After a career within big pharma companies in Japan such as MSD Japan and GSK Japan, he started working for a domestic CRO company (Clio Science, Inc.) in 2010 as General manager of the clinical research department before being appointed as CEO. After the acquisition of the company by Quintiles Transnational Japan for which he was assigned Senior RA Director due to his deep experience, he became in 2016, a key member of Japanese local midsize CRO as Director of CRO business division in charge of the clinical operations. Within AICROS he is responsible to cover Asia.