Medical Writing for clinical trials entails developing the documents required for all stages of the trials, including their initiation, conduct, completion, and reporting. Medical writers create study protocols and protocol amendments; patient information and informed consent forms; clinical study reports (CSRs); and biostatistical, safety, and bioanalytical reports. Medical Writing is crucial in compiling the investigator’s brochure & IMP dossier.
The number and complexity of clinical trials conducted globally have increased over the last decades. Thus, the number of registered clinical studies worldwide has risen from 157,917 in 2013 to 434,335 as of November 2022. In addition, the enhanced complexity of clinical trials is underscored by the increased number of collected endpoints and data points, performed procedures, involved investigative sites, and eligibility criteria for study participation.
Medical writing is an essential component of the clinical development of New Chemical Entities (NCEs) or new Investigational Medicinal Products (IMPs). Medical writing for clinical trials, regulatory writing, and communication activities all contribute to the successful conduct and completion of clinical drug development. However, medical writers need diverse skills to perform this broad range of activities, including excellent English knowledge, subject expertise, scientific academic training, and the ability to collaborate, effectively manage projects, and work under tight deadlines.
Regulatory Medical Writing
Together with regulatory affairs professionals, medical writers are responsible for preparing documents for regulatory submissions and for ensuring their persuasiveness and compliance with regulatory requirements. For example, through regulatory medical writing writers create electronic Common Technical Document (eCTD) format applications, including Investigational New Drug Applications (INDs), Clinical Trial Applications (CTAs), and New Drug Applications (NDAs). In addition, they are involved in interactions with regulatory agencies, including preparing regulatory review responses and briefing documents for regulatory agency meetings and participating in the meetings themselves. Similarly, medical writers create protocols for submission to ethical review boards and participate in board meetings.
Medical Writing for Clinical Trials: Creation of Scientific & Educational Documents
Medical writers in collaboration with the scientific team compile scientific publications, abstracts, and posters to communicate study results with researchers outside their organizations. In addition, they create educational documents to promote understanding of the characteristics of NCEs and IMPs and to disseminate study findings.
How Advances in Digital Technology Transform Medical Writing
The development of digital health and artificial intelligence (AI) is transforming the field of medical writing. Implementing new digital technologies can optimize work processes and efficiency, enhance research and development (R&D) outputs, and lower associated costs.
Digitalization has led to major changes and advances in both regulatory medical writing and submissions and the publication of scientific manuscripts and educational materials. For example, electronic formats have been implemented in the submission of regulatory documents, thus optimizing information sharing and work efficiency. In addition, the digitalization of the publication process has shortened the turnover and publication times and has facilitated the access of a larger audience to the published materials.
AI tools have been introduced into the workflow used by medical writers and are becoming more broadly implemented with each year. Artificial intelligence tools can facilitate the process of literature review (e.g., Semantic Scholar, Penelope.ai, and Elicit), medical writing (e.g., Writefull, CoSchedule Headline Analyzer, Quillbot, Wordtune, and ChatGPT), and figure generation (e.g., DALL-E 2). In addition, they play an important role in data processing and analysis by helping to promptly process large volumes of data and identify trends that may be difficult to detect manually.
These innovations have evidently made considerbale advances when it comes to medical writing for clinical trials and regulatory submissions. However, advances in digital technologies also pose new challenges and requirements for the qualifications of medical writers. As a result, medical writers need to acquire a wide range of career skills to utilize the opportunities offered by the development of digital technologies and AI.
BioPharma Services Medical Writing Team
A Full Suite of Writing Services
Clinical trial & program documentation
Protocol synopses; protocols and amendments; informed consent forms; CSRs; and safety, pharmacokinetic, biostatistical, and bioanalytical reports for different phases of clinical trials. BioPharma Services’ team of medical writing for clinical trials has developed a variety of complex protocols for drug-drug interaction, fixed dose combination, food effects, and generic bioequivalence studies of oncology medications in normal healthy volunteers (NHVs). They have also created CSRs for these designs for numerous clients and have facilitated the CSR submission to a number of regulatory agencies.
Regulatory submission documents
Applications in an eCTD format or without eCTD format, including CTAs for pharmaceutical drugs, medical devices, and their combination as well as regulatory documents for pre-CTA meetings; agency response reviews; regulatory briefing documents for agency meetings; and participation in meetings with regulatory agencies. All of these activities are performed in a close collaboration with BioPharma Services’ regulatory affairs professionals.
Ethical review board submissions
Submissions to and meetings with ethical review boards. Our medical writer team has established great relationships with ethical boards and works with them perfectly to receive approvals on time.
Research manuscripts and presentations and posters for scientific meetings
BioPharma’s medical writers not only handle the content creation aspects, but can also contribute to data assessment and analysis. For example, in a recent project, our medical writer team created a poster on region-specific requirements for a generic transdermal drug delivery system (TDDS), assessing the pre-clinical studies that are required for NCEs and new formulations of cannabis products.
Creation of educational or testing materials for healthcare professionals
We have been involved in the creation of educational materials for healthcare professionals that can help advance the diagnosis and treatment of medical conditions. Thus, in collaboration with MDBriefCase, our medical writers have prepared generic assessments to survey physicians’ awareness of widespread diseases.
Publication of blog articles
BioPharma’s medical writers also develop blog articles to raise awareness of important issues related to their work. An example is a recent blog article on regulations regarding cannabis non-therapeutic research.
A Team of Qualified & Experienced Medical Writers
The combined experience of our medical writers exceeds 30 years, and they have expertise in various therapeutic areas.
A Multidisciplinary Collaborative Effort
BioPharma’s medical writers collaborate closely with other experts in our organization, including regulatory affairs professionals, biostatisticians, clinical pharmacologists, physicians, pharmacokinetic scientists, bioanalytical scientists, and data and project managers. This approach enables us to offer our clients overarching and effective solutions that address all needs of their clinical drug development programs.
Experience Working with Numerous Regulatory Agencies
Together with BioPharma’s regulatory affairs professionals, our medical writers ensure that the communication with regulatory agencies is efficient, and all regulatory submissions are handled in a professional and timely manner. Using this strategy, our team has successfully undergone more than 30 regulatory inspections by various agencies, including the United States Food and Drug Administration (FDA), The Health Canada Therapeutic Product Directorate (TPD), World Health Organization (WHO), European Medicines Agency (EMA), United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA), and Brazilian National Health Surveillance Agency (ANVISA). For example, our medical writing and regulatory affairs departments have met with representatives of Health Canada to discuss the concerns of the regulators regarding cannabis non-therapeutic research.
Client-Centered & Quality-Focused Approach
All BioPharma experts, including our medical writers, ascertain that the solutions we offer are tailored to the specific needs of our clients’ drug development programs. To achieve this goal, we have thorough discussions with our clients and consider their preclinical datasets in the design of clinical trials.
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Medical Writing FAQ
What is Medical Writing in Clinical Research?
Medical writing is a critical aspect of clinical research that involves the development and production of various types of documents required throughout the drug development process. Medical writers play a critical role in translating complex scientific data into clear, concise, and accurate documents that are necessary for regulatory submission, scientific communication, and stakeholder engagement. The types of documents that medical writers produce include investigator brochures, protocols, informed consent forms, clinical study reports, regulatory submissions, and many others.
How Does a CRO’s Medical Writing Team Support Drug Development Sponsors?
BioPharma Services’ medical writing team provides a range of support services to drug development sponsors. They work collaboratively with other members of the project team such as Clinical Pharmacologists and Pharmacokinetic scientists to develop the study design and interpret the study results to ensure the timely delivery of high-quality documents that meet the sponsor’s needs and regulatory requirements. The medical writing team can provide expertise in writing, editing, and reviewing documents, as well as in ensuring compliance with regulatory guidelines and standards. They also work closely with the sponsor to understand their specific needs and develop customized solutions that meet those needs.
How Do Medical Writers Ensure That Documents Are Accurate, Scientifically Sound, and Compliant With Regulations?
Medical writers ensure the accuracy, scientific validity, and compliance of documents by adhering to best practices, following regulatory guidelines, and applying their scientific expertise. They ensure that the document’s content is supported by the data, references, and appropriate literature. They also work to ensure that the document meets regulatory requirements, such as those outlined in the International Council for Harmonisation (ICH) guidelines, Health Canada guidelines, FDA guidance, and other relevant guidelines. Additionally, medical writers follow a rigorous review process that includes quality control, review by subject-matter experts, internal review and review by quality assurance team.
How Can Drug Development Sponsors Engage With Our Medical Writing Team and Understand The Process For Requesting Services?
Drug development sponsors can engage with a BioPharma Services’ medical writing team by contacting the team directly or through their project manager. The medical writing team will work with the sponsor to understand their specific needs, project requirements, and timelines. Once the scope of work is defined, the team will provide a proposal outlining the services and deliverables that they will provide, as well as the timeline and budget. Once the proposal is approved, the medical writing team will work collaboratively with the sponsor to develop the required documents and deliverables. The process may include several rounds of review and feedback to ensure that the documents meet the sponsor’s needs and regulatory requirements.
How Can a Medical Writing Team Help With Regulatory Submissions?
A medical writing team can play a critical role in preparing regulatory submissions such as Investigational New Drug (IND), Clinical Trial Application (CTA) and New Drug Application (NDA). They can help to develop and write part of the necessary documents for the application including protocols, investigator brochures, and other supporting documents in collaboration with the regulatory team. They can also provide regulatory guidance and ensure that the submission is compliant with relevant regulatory guidelines and standards. The medical writing and regulatory team can work with the sponsor to coordinate the submission process and ensure that all necessary documents are provided to the regulatory agency on time. Additionally, they can support the sponsor during the review process by responding to queries from regulatory agencies and ensuring that any necessary revisions are made to the submission.