Your Premiere Medical Writing Partners — Without Question
When timelines are short and resources are tight, partner with a clinical research and medical writing team with the expertise and capacity to deliver clear, compliant deliverables.
Founded in 2022 by three experienced medical writers and clinical researchers, Heile Töllner Brandt supports medical device manufacturers with clinical investigations, medical writing, and regulatory consulting. With a wide range of therapeutic area expertise and decades of collective experience in clinical research and medical writing, Heile Töllner Brandt delivers clear, complete clinical investigation documentation, clinical evaluation reports (CERs), and other regulatory documents that minimize queries from notified bodies and competent authorities.
The Heile Töllner Brandt GbR Team
Anna Heile, DVM, Ph.D.
Location: Frankfurt, Germany
Medical device therapeutic area expertise: Neurovascular, cardiovascular, orthopaedics, sports medicine, dental products, surgical instruments, breast implants, sleep devices, spine devices, epilepsy
Anna Heile, DVM, Ph.D., brings over 15 years of experience in clinical research and medical writing, including preclinical research and the set-up and execution of first-in-human, pivotal, and post-market clinical follow-up (PMCF) studies. Her expertise covers the full clinical investigation lifecycle: protocol development; study start-up, including competent authority and ethics committee submissions, site selection, and site qualification; monitoring; data management, including the build of electronic data capture (EDC) systems in Medrio and Castor; safety review; site and study close-out; and clinical investigation reports, prepared in collaboration with the study statistician. Her additional medical writing experience covers clinical evaluation reports (CERs) as well as summaries of safety and clinical performance (SSCPs) and standard operating procedures (SOPs). Before starting Heile Töllner Brandt, Anna worked with Johnson & Johnson, Stryker, ACE Medical, Vascular Dynamics, and MAXIS Medical (CRO).
Kathrin Töllner, DVM, Ph.D.
Location: Hannover, Germany
Medical device therapeutic area expertise: Sports medicine, orthopaedics, neurovascular, cardiovascular, surgical instruments, software, dental and craniomaxillofacial products.
Kathrin Töllner, DVM, Ph.D. spent ten years in academic basic research studying epilepsy before moving into medical writing in 2016. She has worked with multiple clients, including Stryker, Bayer and ACE Medical, to develop CE marking strategies, clinical evaluation plans (CEPs), CERs, SSCPs, PMCF reports Periodic Update Safety Reports (PSURs) and systematic literature reviews. As a technical writing manager for Johnson & Johnson, Kathrin trained and supervised a team of medical writers producing CERs, SSCPs, and other CER-related documents for DePuy Synthes Mitek, J&J's sports medicine company. In addition, she has extensive experience in safety management, which has been a central part of her work in clinical trials. She has also supported the set-up and execution of pivotal and post-market studies and contributed to data management, including the build of electronic data capture (EDC) systems in Medrio.
Claudia Brandt, Ph.D.
Location: Hannover, Germany
Medical device therapeutic area expertise: Neurovascular, cardiovascular, general surgery, orthopaedics, sports medicine, software, dental and craniomaxillofacial products.
With over 15 years of experience as a post-doctoral fellow and senior scientist researching the basic principles of psychiatric disorders, antiseizure, and antiepileptogenic treatments, Claudia Brandt, Ph.D., brings a mix of clinical, academic, and industry experience to Heile Töllner Brandt. She has developed CEPs, CERs, PSURs, SSCPs and PMCF reports for clients such as Johnson & Johnson, Bayer and Stryker. As both a scientist and freelance medical writer, Claudia has developed and directed systematic literature reviews, as well as studies and reviews for peer-reviewed scientific journals. She works with literature data management systems (DistillerSR) and has extensively tested AI-based tools to evaluate their suitability for literature review. Her work also extends to clinical investigations, where she contributes to the set-up and conduct of pivotal and post-market studies, including safety management and data management with electronic data capture (EDC) systems in Medrio.
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