- Category: Medical Documents
- Published: 05 August 2015
Medical writing and submission involve putting together scientific information by a specialized writer who understands both the source of the information and the target audience. It is a crucial part of communicating the advances in medicine, thus requires focus and attention to details. Because the writers are solely responsible for the overall quality of the document, we ensure the accuracy and consistency of the content. We also adhere to the required guidelines. Some of the medical documents that our team of experienced writers can help you prepare are discussed below:
Clinical development plans
A clinical development plan is a document that describes the clinical studies that experts should perform during certain active medical procedures, substance or treatment strategy. Its aim is to submit the data from the study as part of an FDA application for commercialization. It is prepared with close collaboration between the writers and members of the regulatory team to ensure the accuracy of the data.
A protocol is a document that gives in details, the objectives, methods, design, organization, and statistical considerations of a clinical trial. It gives the trial's rationale and background information, clearly outlining its study plan. It should have a carefully designed plan that safeguards the participants' health and safety. It should also describe the procedures, the schedules for tests, who to participate, dosages and medications, and the duration. The document should also have a declaration at the end. The version should have dates and a number, and use a formalized convention. When preparing this kind of document, it is important to involve the participation of the patients and the public to ensure it captures their needs.
Clinical study reports
A clinical study report (CSR) is a medical document that gives long and detailed information about a clinical trial; focusing on the methods and results. It also focuses on the trial's safety flaws. A CSR should start by showing the methods used followed by the results. It should begin with a synopsis, followed by ethical information, the administrative structure, introduction, objectives, methods and the changes to the study. The document should be summarized and written in past tense. To make it even more clear and comprehensible, it should contain information from the existing sources in a table. It should be accurate and detailed with only the relevant information. The results should be put into the context of the available data and making references to developing studies. It should communicate clearly to the intended audience to make its understanding easier.
Clinical sections of common technical documents (CTDs)
A Common Technical Document (CTD) is an internationally recognized registration dossier that details specifications of a medical product. The specifications are in regards to new drugs that practitioners submit to a regulatory authority. The document is supposed to improve the communication between the medical industry and public health. It is one of the technical requirements when one needs to register a pharmaceutical product. The clinical sections that our writers can prepare include clinical summary, clinical overview, non-clinical summary and non-clinical overview.
Clinical sections of new drug applications (NDAs)
A New Drug Application (NDA) is used by drug sponsors to seek approval of the Food and Drug Administration (FDA) for new pharmaceutical products' commercialization. The role of the NDA is to give enough information to the FDA reviewers, giving them permission to establish the safety, efficacy, labeling and preservation of a proposed drug.
Abstracts, manuscripts, and journal articles.
Abstracts are the initial steps of reporting scientific research or clinical trials. From a complete study, the information is put together into an abstract. It then evolves to a manuscript before it is presented to a journal for publishing. The process could delay for about 1 to 2 years after the study is complete. It reports to the medical community the new developments in the field, showing methods, hypotheses and results of the study. A manuscript, on the other hand, gives a detailed presentation, including the methods used, complete findings and the relationship with previous studies.
Investigator brochures and annual updates.
An Investigator's Brochure (IB) is a document that summarizes the information obtained during the trial stage of a product. The document is regularly updated as new details of the product emerge. It gives insights for the study and introduces aspects of a clinical protocol such as safety, frequency, and dosage of the product. It should be well-written and concise to enable its readers make quick references.
Informed consent forms.
An informed consent form is a medical document issued at the beginning of a medical research detailing the research study and giving the potential participants their expectations at the end of the process so as to make informed decisions. It should be in simple and clear language. And to enhance a more comprehensive understanding devoid of scientific terms, the researcher should use tables and flowcharts.
The document should be typed using a 12-point font to enhance reading for the participants who could be visually impaired, elderly or children. The form should have space for signatures; for the researcher and the participant. A consent form should be detailed enough, and provide information on the purpose of the study, the procedures involved, risks, benefits, confidentiality and withdrawal from the research. It should answer the questions the subjects are likely to ask and emphasize the fact that their participation is voluntary.
Periodic Safety Update Reports (PSURs)
A periodic safety update report (PSURs) is a document that provides detailed evaluation of the balance between risk and benefit of a medicinal product at a given time. It takes into account the emerging issues regarding the product. Different countries or regions have laws requiring market authorization holders to submit PSURs at some time points after a medicine is authorized. It is an important document for effective risk communication and ensuring product efficiency with time.
Pre-FDA meeting briefing documents
In a medical product development phases, the manufacturers need to be constant communication with the Food and Drug Administration (FDA) to avoid delays in the process. Before making a submission, a manufacturer needs to prepare documents that request for its tracking and logistics and their appropriateness. The suggestions from the FDA can be used to improve on the documents to avoid clinical hold orders.
Response to clinical hold orders
A clinical hold order is an official document from the FDA to an applicant directing them to suspend an ongoing clinical investigation or delay a proposed investigation. It may be partial or complete. The applicant may be allowed to respond within a specified period, which the agency then evaluates for further action regarding the hold. The applicant's response should however only address the issues raised in the clinical hold.
Pre-clinical study reports, expert reports, and summaries.
These are reports made from an ongoing scientific research and contain studies that are exploratory and for testing hypotheses. The reports give a comprehensive review of a medical product, giving details of its dosing and toxicity levels. The researcher should state whether the product is safe for testing on human beings. The reports should be complete and clearly written to aid the users quick understanding.
Data safety monitoring board (DSMB) manuals
Data safety monitoring board is an independent team of non-conflicted experts which monitors the progress of different phases of a clinical trial. The team brings together scientists, statisticians, physicians, among others, who monitor the data and safety of an on-going scientific trial. The recommendations of the team as, the research progresses, determines whether it is likely to be successful or not. A DSMB manual, therefore, details what the team should look for in a given trial. The document is an integral part of any trial.
Written and tabular summaries
Written and tabulated section of a clinical or non-clinical document introduces the reviewer to a pharmaceutical and what its clinical use will be. It covers the structure of the pharmaceutical and its pharmacological properties. The summaries should be about 100-150 pages.
Benefit/risk assessment reports
A benefit/risk assessment report is a document that evaluates the benefit-risk balance of a medicinal product as well as the relationship with the emerging risks and benefits. The report should give a concise analysis of any emerging safety information relevant to the product. It should also contain information on whether the report obtained conforms to the previous or existing knowledge of the product's profile.
Medical and scientific literature reviews
A literature review is a summary of related studies to a prospective field of research. A medical or a scientific literature review should, in 3000 words, give a detailed account of scientific works that have been published and are relevant to the area of study. It should introduce the subject of study, present its objectives, hypotheses and the methods to be used. The introduction should critically assess the existing works and find the areas of controversies or weaknesses. The hypotheses should be as clear and valid as possible and in about 450 words. The methods should be realistic and show that the scientific research is feasible. A medical or scientific literature review is important in showing the progress in scientific knowledge.