We understand the importance of a clinical trial that is written in a clear and precise manner in order to be understood by IRB, FDA, and any other reviewers. It is risky to submit a poorly written protocol which leads to a huge loss in time and money. Further, delays and additional revisions cost significantly. However, our qualified regulatory medical writing services helps you in composing a well-written clinical trial and ensures that your clinical trial protocol is reviewed, edited and proofread properly that helps you save time and money and importantly the reputation of you/your organization.
Our team has capabilities and skills to prepare regulatory submissions documents to seek US Food and Drug Administration (FDA) approval for drugs and devices. Our Medical Writing Solutions currently offer regulatory compliance solutions in preparing essential documents for clinical trial submissions and other paraphernalia associated with clinical research. Our Experts are trained in developing clinical study reports, investigators’ brochures, consent documents, protocols, patient narratives, selected eCTD modules, periodic safety update reports (PSURs), Development Safety Update Reports (DSURs) and Annual Safety Reports (ASRs). The experience that our experts hold is immense in these past years by handling a variety of therapeutic areas that include immunology and vaccines.
- Our medical writers can prepare a wide range of documents involved in the regulatory process. All our regulatory writing is done in accordance with our SOPs compliant standards.
- We scrutinize the content of our medical writers and ensure that the documents we produce are scientifically accurate. When writing clinical study reports using data supplied to us we have often uncovered problems with the data or analyses that would have been costly to the entire research: for example, inappropriately calculated statistical hypothesis tests that could have led to the wrong conclusions had they not been corrected.
Protocols and Protocol Amendments
Our team of medical writers has considerable experience writing clinical study reports and protocols. We ensure that we provide the best of services to our client and in turn ensure the following
- We prepare study reports that are fully compliant with International Conference on Harmonization (ICH) guidelines
- We use standard format for styling either recommended by the client or use an in-house format.
- We write the complete reports without any ambiguity.
- Presents the findings of the study in a lucid and concise manner.
- Succinctly discuss the clinical relevance of the results and spot/report any bewildering findings or potential problems
- We follow stringent QC to ensure accuracy and regularity.
- We use appropriate methodology and strategic statistical analyses that are tailored for the specified study objectives.
- The study will adhere to guidelines for Good Clinical Practice and other ethical considerations.
Investigators Brochure (IB)
Investigator Brochure characterizes the investigational material (new drug, biologic, or medical device) regarding its physical properties and will contain information from some or all of the following disciplines: pharmacology, toxicology, and pharmacokinetics/pharmacodynamics. It will also contain a summary of all clinical research studies, evaluation of risks and benefits associated with the proposed clinical research and a complete reference list.
The Investigator Brochure is the chief source of information for investigators who are keenly participating in a clinical study and provides the scientific and medical basis for each clinical development program for a specific drug, biologic, or medical device. This document requires continuous updates with innovative medical research information as and when available. Our team of medical experts has vast experience in developing investigator’s brochure.
Informed Consent forms
Millions of volunteers participate in government- and industry-sponsored clinical trials each year. Prior to agreeing to participate, every volunteer has the right to know and understand what will happen during a clinical trial. This is called informed consent and it is a process that can help you decide whether or not participating in a trial is right for you. It is important for the consent document to be clear and have a concise explanation of the various elements of the research study. In addition, the language should not contain any element of coercion nor appear to waive subject’s legal rights, or release the investigator, sponsor or institution from liability for negligence (no exculpatory language).
The structure of the consent document at Medical Writing Experts entails the following:
- Heading and Title of the Study
- Identification of Investigators
- Study Purpose
- Study Procedures
- Risks and Discomforts of the Study
- Alternative Treatment (if any)
- Compensation for Injury (if applicable)
- Costs and Compensation of the Study
- Withdrawing from the Study
- Consent Statement
Phase I To III Study Reports
We are experts in writing, editing, or managing reviews of final study reports, serious adverse event narratives, manuscripts, and NDA and IND submissions. Our consultants, including CRAs, medical writers, and contract negotiators, have extensive clinical research experience.
- Clinical Study Reports Appendices
- Clinical Study Report (Full, abbreviated, or Synoptic, ICH E3-Compliant CSR)
- Patient Narratives
- Clinical Development Plan
- Common Technical Document (CTD) modules such
- Clinical Summaries & Overview
- Study Reference Manual
- CTD modules
- Annual (ASR) / Period Safety Reports – PSURs / PBRERs, PADERs (Periodic Adverse Drug Experience Reports, DSURs
Guidelines issued by regulatory agencies and the international organizations define rigorous responsibilities for safety assessment and reporting in clinical studies, including narrative statements on special categories of adverse events for individual subjects. Our proficient medical writers can produce detailed patient safety narratives tailored to the particular safety concerns of your clinical study report and submission.
Ensure your clinical study reports and submission is in full regulatory compliance, including all required individual patient safety narratives. We will work with you to present high-quality patient safety narratives that are in compliance with ICH guidelines, written to your specifications and that support your submission.
- Non Clinical Study Reports
- Non Clinical Summaries and overviews
- Package Inserts (prescribing information) & Patient Information Leaflets
- Clinical study reports, web synopses
- Subject narratives
In-House Data Summaries
We delivers all-inclusive data management services utilizing efficient yet meticulous processes coupled with advanced technologies. We design, build, and deploy clinical databases faster than the industry norm; and our highly experienced team of data management professionals, manages your clinical trial data with keen precision and accuracy. The result of such good management results in cost efficient data management, intuitive clinical database and ultimately, accurate and clean data.
Our goal is to provide an optimal solution for your trial and thereby allow your study to move forward quickly and efficiently as possible without compromising data quality and the integrity of your clinical study. We provide in-house data summaries to help you with all your clinical data.
Safety Surveillance Plan
The need for safety surveillance studies stems from inherent limitations in the clinical trial process used for regulatory approval. Medical Writing Experts has experienced clinical and medical data professionals who can develop an effective pharmacovigilance program. Using the several event reporting systems, We provides comprehensive clinical and post-marketing adverse event (AE) and serious adverse event (SAE) reporting, including post-marketing coverage.
Our safety surveillance plans include the following
- Non-serious and Serious Adverse Event Case Processing
- Data Entry and Coding
- SAE Narrative Writing
- Physician Medical Review
- Preparation of Reports
- Periodic Safety Update Reports (PSURs)
- Periodic Adverse Drug Experience Reports (PADERs)
- EU Annual Safety Report (EASR)
- Pre- and Post-Clinical Risk Management Plans (EU RMPs)
Case Report Forms
CRF (case report form) is an official clinical data recording document or tool used in a clinical study. A properly designed CRF saves time and money, can be reused and is critical to the accuracy and completeness of the data. CRF collects all relevant data in the required specific formats by the protocol compliance requirements of regulatory agencies. Further, it allows for efficient and complete data processing, analysing and reporting. Although CRF designs vary between clinical researchers organizations, they need to include all efficacy and safety parameters that are specified in the protocols. Our dedicated CRF design team use latest tools to create Case Report Forms. Each CRF is based on our standard library of CRF modules. We tailor CRFs by your needs to ensure you receive the module of your requisite.
Our qualified regulatory experts has obtained the experience to make optimal study plans and improve protocols and case report form for research for a wide range of trials. Our workforce has the experience and the learning in all areas of clinical research, biostatistics, and administrative issues to lead the design of your study as needed. Our protocol and CRF advancement administrations are legislated by thorough Sops and follow appropriate guidelines
At Medical Writing Experts
- Write and develop a wide range of regulatory writing documents and other clinical research documentation for any phase of clinical development (Phase I through Phase III)
- Collaborate and coordinate with large cross-functional teams of clinical research experts
- We tailor the regulatory submission documents to our clients’ specifications templates and style guides. We are flexible to work in the client’s data management system.
The nuances of medical writing and the upward trends
The regulatory stipulation of Bio-Medical devices to achieve a CE
Get in touch to find out how we can help your organisation.
Our team are ready and would like to speak to you, to understand more about your organisation and how we can help you achieve your goals.