Medical writers play an important role in translating complex medical and scientific information into easily understandable summaries for a wide audience. At Regmarole, LLC, we have over 15 years of experience creating regulatory documents that suit the needs of the biopharmaceutical industry. We are also passionate about making sure clinical information is transparent and responsibly disclosed in a timely manner for patients and their caregivers.
Clinical and regulatory documents are crucial for clinical studies. Documents like the clinical protocol, Investigator’s Brochure, and clinical study report ensure ethical and procedural conduct, data quality, and compliance with Good Clinical Practice (GCP) and ethical guidelines, as well as Health Authority regulatory requirements, are being utilized throughout a program’s lifecycle.
Health literacy incorporates a public health perspective to ensure that clinical trial information is communicated in a way so that study participants can focus on the ability to make well-informed medical decisions rather than appropriate ones. Plain language summaries are being increasingly used to emphasize a participant’s ability to not simply understand health information, but to be able to use it.
Clinical trial transparency not only fulfills regulatory obligations, but it also goes a long way in establishing public trust and perception of clinical trials.
A commitment to responsible clinical trial data sharing and results disclosure policies and practices has unlimited potential to accelerate scientific progress and improve public health.
Regmarole, LLC delivers exceptional service as measured by consistent work quality, commitment to finding the best solutions to address complex scientific questions, and timeliness in all areas of medical writing and clinical trial transparency deliverables.
We listen to our clients and are flexible because every product and program is unique. Regmarole, LLC empowers clients and supports them in making the best decisions to bring products to market and significantly impact patient care.
We have qualified medical writing and clinical trial transparency experience working with large pharmaceutical companies and smaller biotechnology start-up companies, in therapeutic areas including oncology, hematology, dermatology, and neuro-degenerative and autoimmune diseases, as well as preventative areas like vaccines.
EMWA is the European Medical Writers Association. EMWA is the network of professionals that represents, supports, and trains medical communicators in Europe and beyond.
The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health.
Regmarole, LLC provides a wide range of medical writing and clinical trial transparency services. From first-in-human protocols to clinical trial results disclosure on public platforms, we successfully support medical writing regulatory documents and clinical trial transparency activities.