Regmarole, LLC

Excellence in Medical Writing
and Clinical Trial Transparency Services

Welcome

Welcome to Regmarole, LLC, a woman-owned medical writing and clinical trial transparency consulting service. Whether you are looking to develop clinical regulatory documents or stay compliant with the latest clinical trial disclosure requirements, we can help you reach your goals!

About Regmarole, LLC

Our Passion

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.

How We Can Help

Our Services

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.

Clinical and Regulatory Document Development

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 and Plain Language Communications

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

Clinical trial transparency not only fulfills regulatory obligations, but it also goes a long way in establishing public trust and perception of clinical trials.

data disclosure preparation

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.

Why choose us?

Benefits of Regmarole, LLC

outstanding Performance

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.

Customer Service

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.

15+ years experience

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.

Testimonials

Kind Words From Clients

Resources

Industry Insights From Regmarole, LLC

EMWA

EMWA is the European Medical Writers Association. EMWA is the network of professionals that represents, supports, and trains medical communicators in Europe and beyond.

DIA Global

DIA fosters innovation to improve health and well-being worldwide.

Regulatory Affairs Professional Society

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. 

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