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*Please note that we are a research service provider, not a pharmacy or clinic, so we are unable to see patients and do not offer diagnostic and treatment services for individuals.

Medical Writing Services

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Clinical research primarily relies on medical writing for regulatory compliance and maintaining accurate documentation. With its depth of experience, Protheragen offers a comprehensive suite of medical writing services for the changing landscape of the pharmaceutical and medical research market.

Introduction to Medical Writing

The process of preparing scientific documents by individuals thoroughly versed in clinical and scientific matters is known as medical writing, and it is a specialised area. Such writers are able to take complex research data and findings and articulate them in the form of written materials that are well-structured, straightforward and persuasive. Such materials meet the requirements of target audiences such as regulatory agencies, medical practitioners, and the scientific community.

Document types related to clinical research. Fig.1 Various documents related to clinical research. (Abhijit T., 2024)

Medical Writing in Clinical Research

As part of international clinical research, medical writing is important for the successful implementation and reporting of clinical trials. It is the medical writer's role to draft various documents which are mandatory for the licensing of new pharmaceuticals, new biologics, and new medical devices as well as communicate the results of the clinical study to researchers, or any interested public.

These documents include:

Protocols and Informed Consent Documents
Clinical experts partner with medical writers to create scientifically sound documents that are adequately lacking in structure. They develop documents that define the objectives of the study including its design, methodology and operational aspects. They also provide an informed consent document which ensures that the participants are aware of the aims, process, risks, and benefits of the study.
Manuscripts and Publications
Collaborating with a principal investigator and subject expert, medical writers will compose manuscripts for submission to a peer-reviewed journal which will enable the wider scientific community to have knowledge of the trial evidence.

Clinical Study Reports (CSRs)
Medical writers create CSRs that are comprehensive and contain information about the methodology of the trial, results of the trial and any conclusions reached. These reports also need to be factual, rational and unbiased to facilitate regulatory submission.
Regulatory Submissions
Medical writers prepare the necessary documents for regulatory submissions which include but are not limited to: Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorisation Applications (MAAs), ensuring all required and accurate information is included within the submitted documents.

Our Services

Protheragen seeks to provide end-to-end solutions for clinical research, thus providing a full suite of medical writing services. A robust medical writing team at Protheragen is backed by a group of professionals with a strong scientific foundation and stays up to date with the latest regulatory documents. Since every client has different clinical research documentation requirements, we provide services that meet their individual needs.

Clinical Development Plans

In collaboration with the client, Protheragen's medical writers and other support members conceive a plan which comprehensively addresses the strategy and roadmap for clinical development.

Protocols

Well researched and formulated protocols of all phases of the clinical trials are formulated and documented by Protheragen's medical writers.

Clinical Study Reports

Protheragen's medical writers prepare substantial reports of Clinical Study (Articles CSR) of pertinent research information. In addition, we provide safety report writing services, including Development Safety Update Reports (DSUR), Periodic Benefit Risk Evaluation Reports (PBRER) and Risk Management Plan.

Regulatory Submissions

According to the relevant guidelines and regulations Protheragen's medical writers prepare all necessary documents for regulatory submissions including downloads for IND, NDA and MAA.

Other Medical Writing Services:

Conditional Marketing Authorization (CMA)
Responses to Questions (RTQs)/Regulatory Responses (across multiple health authorities)
Pediatric Investigation Plans
Pre-Meeting Packages/Briefing Packages
Pediatric Study Plans (including waivers)
Health Outcomes Economics/Real World Evidence Documents

Investigator's Brochures (IBs) and IB Updates
Fast Track Designation
Orphan Drug Designation (ODD) Application/Annual Reports
Orphan Drug Applications
Immunogenicity Reports
Ethnic Sensitivity Reports

By partnering with Protheragen, clients can leverage the company's expertise and comprehensive medical writing services to ensure that their clinical research documentation is of the highest quality, compliant with regulatory standards, and effectively communicates their scientific findings to the broader medical community. If you are interested in our services, please feel free to contact us.

Reference

Abhijit, Trailokya. "The role of medical writing in clinical research." International Journal of Recent Innovations in Medicine and Clinical Research 6.2 (2024): 53-55.