Accelsiors CRO & Consultancy Services

Mihály Juhász is the founder and CEO of Accelsiors CRO and Consultancy Services Ltd. He has nearly 20 years of international pharmaceutical industry experience. Prior to founding the Accelsiors in June 2002 he has worked in a variety of management positions for global CROs and big Pharma focusing on complex development programs in innovative biologics and biosimilars. Dr. Juhász is a specialist in clinical pharmacology, with an extensive experience and expertise in the fields of endocrinology, immunology, neurology and pediatrics.

Vid Stanulovic joined Accelsiors in 2004 after holding several positions in global CROs like Quintiles and i3 Research. He currently heads a team of physicians responsible for planning, conducting and reporting the results of clinical evaluation of drug safety. Drug safety responsibilities include the pre-study activities such as: determination of safety evaluations, assessment of appropriate patient populations; On-study activities like managing DSMBs, outcome evaluation committees, participation in steering committees and routine safety measure like immediate processing of serious and alert events, creation of developmental safety update reports; Finally, post study activities include final data review, evaluation of sub-populations for post hoc evaluation etc.

He also assumed the responsibility of Head of Accelsiors Medical Writing Unit, which is in charge of the development of study protocols, investigators brochures, clinical study reports, journal publications, conference posters and presentations.

Richárd Sándor leads Accelsiors Logistics and Study Set-up unit. After joining Accelsiors in 2003, he was focused on developing the logistics and set-up services within Accelsiors, as one of the key components and conditions for successful clinical trial conduct in Central and Eastern European region. Some of his key responsibilities include coordination of all study set-up activities, selection and management of third party vendors, management of medicinal and non-medicinal supplies, coordination of central laboratories, selection and supervision of courier services and appropriate updating on customs, distribution and shipping regulations. He is based in Budapest, Hungary, and leads the team of dedicated logistics and set-up professionals located throughout Accelsiors region of operations. In addition he is very successfully managing some complex studies for our key customers.

Bojana Gaćeša leads and is responsible for Accelsiors Regulatory Services. She joined Accelsiors in 2007, bringing in an extensive pharmaceutical industry experience. By leading a team of dedicated regulatory affairs professionals, she oversees and coordinates all Accelsiors’ CTA filings and other correspondence with relevant authorities. She serves as a primary point of contact to all sponsor companies, with regard to regulatory topics and issues. As one of the extremely important integral parts of regulatory services, she is also in charge of regulatory risk management, which includes the set up of appropriate action plans, contingency plans and solutions, in order study start up phases can be completed as agreed with the clients. She is also extensively involved in the appropriate regulatory training of various study team members.

After joining Accelsiors CRO in 2003, Andrea Csillag has gained an extensive experience in data management, resulting with her promotion to the Head of Biometrics at Accelsiors CRO in 2009. She works directly with sponsors, clinical and operation teams to continually develop processes and systems for the effective delivery of biostatistical services to Accelsiors’ customers. Some of her major responsibilities are the development of eCRFs, computer system validation, user acceptance testing, creation and full implementation of Data Management Plans, designing of CRFs for studies in various therapeutic areas, etc. She leads a team of highly trained and skilled individuals, ensuring that the quality of data delivered at the end of the project exceeds clients’ expectations.

Tamara Nović joined Accelsiors CRO in 2007, bringing in an extensive experience in systematization and cataloguing of documents gained in the National library. Her responsibilities cover the width of administrative jobs within Accelsiors. By leading the group of Record Unit professionals, she is mainly concentrated to establish, maintain and keep Trial Master Files in perfect order and shape. Under her lead, Accelsiors Record management team established the full electronic archiving system in addition to and as a mirror and back-up of the paper archive, covering all project stages, from study set-up till the trial close out.

Mrs. Počuča has more than 10 years of experience working on various positions within contract research industry, as well as more then 5 years of academic experience. After spending several years at i3 Research, she joined Accelsiors CRO in 2004, and acts as the Head of Training at Accelsiors CRO since 2005. Responsible for the development of annual training plans, she oversees the complete training program at Accelsiors and ensures its correct and full implementation. She prepares and controls the appropriate preparation and conduct of training courses, both for new employees and for already experienced individuals who require certain extension of capabilities in a particular field of operations. Mrs. Počuča is also responsible for job interviews as well as for the development and maintenance of Accelsiors’ appraisal system.

Dr. Cvejić is responsible for Accelsiors QA program development and organization, and for QA staff development and management. She has joined Accelsiors is 2010 and brings in more than 12 years of academic experience, with an exceptional background in ISO accreditation procedures. Dr. Cvejić started her career as a person responsible for implementation of safety measures and procedures in a microorganism biochemistry laboratory, and from there she progressed her career in quality assurance. She currently holds the position of Associate Professor and the School of Pharmacy in Novi Sad, Serbia.

Pavel Tumanov, MD, joined Accelsiors in 2003 after holding several positions in global pharmaceutical companies like GlaxoWellcome and GlaxoSmithCline. He is currently local head of team responsible for management, conducting and supplying of clinical trials in former Soviet countries, mainly in Ukraine, Russia and Belarus. The main responsibilities include: Recruiting on personell, coaching, working coordination; Logistic management; Study start- up management; Identification of regulatory requirements, primary contact with regulatory authorities and Ethics Committees; Feasibility studies, identification of investigators; Contract negotiation, local vendor selection.

Since 2007 he also assumed the responsibility of Managing Director of Ukrainian office and responsible for financial and legislation management.