Services – Regmarole, LLC

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Medical Writing and Clinical Trial Transparency Services

Medical writing services play a critical role in enhancing a clinical program portfolio. Medical writers have the expertise to present complex medical information in a clear and concise manner. This makes the data accessible to a wide range of audiences, including patients, healthcare professionals, and regulatory authorities. Medical writers are familiar with regulatory guidelines and can ensure that all documents are compliant. This is crucial for clinical trial applications, progress reports, and final reports. Medical writing services can streamline the process of document creation, saving time and resources. They can also help to avoid delays in the clinical trial process due to poorly written documents. Medical writing services often include rigorous quality control processes. This ensures that all documents are accurate, well-written, and free from errors. Medical writers have the scientific knowledge to understand and accurately present the results of clinical trials. This adds credibility to the clinical program portfolio.

With the increasing number of clinical trials being conducted annually, it is necessary for all clinical data to be available to the public. Many studies conducted all over the world are not being published as articles and being made accessible to public. Registration before recruitment helps improve transparency, regular updates to the clinical trial information increases patient knowledge of available medications, and industry watchdog groups now can identify clinical trials that have not been published for various reasons.

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 and data disclosure preparation

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.

scientific research publication drafting

A published scientific research journal or conference is the best way to spread the word about your clinical research and work to the scientific and medical community. Presentations of peer-reviewed research are vital in ensuring information contributes to the existing body of knowledge. The process of publication and presentation of research involves editing and formatting to the journal or conference standards and medical writers are invaluable in this step.

standards and process mapping

Standards are established guidelines or criteria that are used to measure the quality and efficiency of processes within the organization and are designed to ensure consistency, reliability, safety, and efficiency.

Process mapping is the visual representation of a process. It shows the sequence of tasks that make up a process from start to finish. It is a helpful tool used to understand and improve processes within an organization.

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.