Accelsiors Medical Writing selects medical writers based on scientific and medical expertise, combined with clinical trials experience. Quality is enhanced by strict adherence to internal standard procedures and applicable guidelines. Your interest and timelines are always the top priority for us.
The competitive advantage of Accelsiors Medical Writing is in our expertise and in selective undertaking of Medical Writing services limited to the areas of expertise. This refers to projects for which clinical services are also offered or areas of extensive experience.
WE ARE CONSCIOUS OF THE IMPORTANCE OF:
We understand that meeting quality standards and timelines; however, we take it one step further, by ensuring:
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MEDICAL WRITING SERVICES:
Accelsiors offers a complete range of expertise in support of your specific needs: Scientific, analytical and regulatory complemented by global resources, state-of-the-art technologies and project management methodology for the most effective execution of your development program across all phases of clinical drug development.
Dr. Mindák has more than 10 years of experience in CRO business and in complex clinical trials across many therapeutic areas, including Cardiology, Dermatology, Endocrinology, Immunology, Oncology, Pulmonology, Rheumatology and Vaccines. He joined Accelsiors in 2018. László is a Medical Doctor and he started his career at AstraZeneca, then acted as Lead CRA at ICON plc. In the last decade he has worked in the Quality Compliance and Assurance area, focused on applied data analytics, process improvements/controls, predictive quality measures and risk assessment methodologies – based on Six Sigma -, beside of the standard QC/QA management tasks.
Sebastian joined Accelsiors in 2012 as an logistic associate moving through positions of clinical laboratory coordinator, manager and then appointed to the position of Director of Vendor Management in 2018. Although in the CRO business for six years, he has experience in the pharma industry for more than 16 years working as field and customer engineer for Agilent Technologies, performing installations, trainings for different instrumental analytical techniques as LC-MS, GC-MS, ICP-MS and tandem mass spectrometry. He has big expertise in Instrument Installation Qualification, Operational Qualification, Performance Verification and Method development and Validation for the techniques mentioned. Sebastian holds a bachelor degree in Chemistry and Master degree in Biochemistry.
Dr. Horvath has over 14 years of post-qualified experience (PQE) and over 10 years in healthcare and 6 years in the Pharma & CRO industries. He has extensive experience in regulatory assistance and labor issues in more than 10 jurisdictions. His past experience includes positions as Legal Counsel at RADITEC Budapest, a Partner at Law Firm Szalma and Partner Budapest. Prior to this he was a Tax Advisor at Nörr, Stiefenhofer Lutz, Budapest, a Senior Associate, Price Waterhouse Coopers Landwell Budapest and an Associate, Pünder-Volhard-Weber-Axter, Budapest. Dr. Horvath completed his bar examination in Budapest and his studies were at Heidelberg, Germany ( LL.M.) and Budapest (Law Degree, JD).
Dusan has 14 years of experience in CRO business. He joined Accelsiors in 2004, as a young medical doctor being Study Site Coordinator and has developed into many positions from Lead CRA, Project Manager to Director of Drug Safety department. In 2017 because of his great management skills, professional background and great experience he was promoted into Senior Director of Drug Safety and Regulatory Affairs department. He has big expertise in neurology and endocrinology and has experience in many clinical studies at international level.
Eva joined Accelsiors in 2012 as the Human Resources Manager. In her role, she is responsible for maintaining and enhancing the human resources by planning, implementing and evaluating employee relations and applicable policies, programs and practices.
Pavel has 15 years of experience in CRO business. He is a Medical Doctor, Specialist in Pediatrics. He joined Accelsiors in 2003 as a CRA and has developed to Local Head of Clinical Operations and than he progressed into a Regional Head of Eastern Europe role. His excellent management skills lead him to be promoted to Senior Manager of Clinical Operations in 2016 and from 2017 he oversee all clinical operations activities for Europe and MENA areas.
John has been in the pharmaceutical industry for almost 20 years with wide ranging experiences from pre-clinical Drug Metabolism and Pharmacokinetics, clinical operations leader for phase I – IV trials. At Accelsiors CRO John is acting as the Head of Clinical Operations in the US while also leading our global Business Development activities. John has experiences working with large pharmaceutical companies like GSK, Teva and Merck as well as emerging companies like Cephalon and Braeburn which gives John a unique understanding of what are the challenges and needs of sponsors and allows Accelsiors to provide quality service to all pharma companies regardless of their size.
Shabbir has over 20 years of experience of clinical development with rotational line management experience in clinical operations, clinical data management (operations, programming, PvG), project management, project finance, and quality with Pharma and CRO. Shabbir started his career with Eli Lilly India as CRA, he has experience of working overseas (Australia and Hong Kong) and managing a data management team in APAC region. He has successfully established and led two Indian CROs and worked for two of top ten global CRO (Parexel and INC) as General Manager for India and led data and clinical operations as his P&L responsibilities respectively. Shabbir has experience of setting up, mergers and acquisitions of companies in India.
Jon has more than 25 years of industry experience in biometrics services in both Pharma & CRO organizations. He lead global data management and biostatistics teams in serving Accelsiors’ Customers. Jon has extensive knowledge across a number of therapeutic areas. He is a recognized expert in data management and serves as the co-Chair of the Association for Clinical Data Management and is an accredited trainer. Jon has previously held leadership positions with GSK, Pfizer and Amgen.
George has 10 years of experience in clinical research. He joined Accelsiors in 2007 and held CRA, CTL and PM positions. Since 2017, he is directing our business development activities for Nephrology and Genetic Diseases projects. George has previously held basic research and teaching positions in academia. He is a biologist with specialization in Biochemistry and Molecular Medicine.
Dr. Timea Gombos is a Medical Doctor, board certified internist. She gained her PhD in clinical sciences, and has several years of clinical experience as an internist. She holds a Master’s degree in Statistics, and has over 5 years of academic research experience as a research fellow and consultant statistician. She is the author on a number of scientific papers and she is the secretary of the Hungarian Society for Clinical Biostatistics.
Dr. Singer has more than 30 years of experience in most biostatistical areas of the Pharma industry, comprising both clinical and pre-clinical research. She is responsible for defining development strategies, study designs, ensuring that the Biostatistics team applies state-of-the-art, efficient methods for the statistical evaluation of clinical results. Dr. Singer is the president of the Hungarian Society for Clinical Biostatistics.
Katalin has more than 20 years of experience in management positions. She joined Accelsiors in 2012 as Chief Financial Officer. As CFO Katalin oversees accounting, business support, financial planning and analysis. Katalin has extensive experience in building and leading finance teams at international companies. Previously, Katalin was CFO at one of the largest Hungarian construction companies. Katalin has a BSc in International Business from University of Economics Budapest.
Dr. Logan has over 25 years’ experience in the CRO industry. His experience spans across leadership of global operations throughout CEE, WE, Asia, Australia, Japan and South Africa. His oversight of international project teams and studies has ensured that process was adhered to and Customers’ expectations exceeded. Kelvin was previously President of Operations Europe and Asia at INC Research and prior to this was Senior Vice President of Operations at Quintiles.
Dr. Mihály Juhász is the founder of Accelsiors. An MD and board certified clinical pharmacologist, he has over 23 years of industry experience in both CRO & Pharma. In addition to this, Dr. Juhász has significant experience in endocrinology studies, with a specific focus on rhGH. Prior to founding Accelsiors, he was the Medical Director at Novartis Biologics (Biochemie) and instrumental in the development of Omnitrop. Dr. Juhász was also a pioneer in Biosimilar development, a key area of focus at Accelsiors.