Medical and Scientific Writing
Whether writing a publication, a study protocol, or a report – conveying a clear message is at the centre of it. Having a clear grasp of the topic is as important in this regard as known your audience. Our team of scientific and medical writers is ready to assist you in your endeavour: Whether you want to publish your study findings in a scientific journal, need to prepare documents for submission or compile a clinical evaluation.
Given our wide range of services at GCP-Service, our team has many hands-on experts that can make the difference your documents.
Profit from our experienced staff and our deep knowledge of guidelines and regulations. We will assure that your documents meet and exceed the requirements, and that your trial are put on track.
Clinical Trial Documents
For clinical trials, the target audience is composed of regulators and ethic committee members of varying background, that want and need to assess if the documents contain all relevant information and are written in a clear and concise manner that avoids ambiguity. Finding a place to tell a story given these requirements can at times be arduous.
Additionally, just as scientific journals have publication guidelines and layouts that must be adhered to, the same is true for the clinical research world: With ICH E6 (R2), ICH E3, ISO 14155, MEDDEV, IMDRF and more guidelines and regulations to follow, there is no shortage of requirements that need to be fulfilled for all relevant documents within a clinical trial.
Our Medical Writing team cooperates with and coordinates the work of our experts in Biostatistics, Product Safety, Regulatory, and Clinical Operations to bring you the knowledge and experience you need to set your project up for success. Together, they will tailor your study documents exactly to your needs or support you by providing input into your final documents. And through all that, we will ensure that your story is being told!
Publishing results in scientific journals or creating an opinion piece can be challenging and time-consuming: Getting all co-authors on board, properly presenting the results, matching the journal’s expectations, and giving a great overview of where the findings can be placed in the scientific context while remaining factually and methodologically.
Our team of Scientific Writer is here to support you in this endeavour, and to organize the process for you. We will make sure that you can stay as hands-off with the project as you want, while we perform the literature search for you, compile methodological information, summarize your project or clinical trial, and put the outcome into context.
And if you want or need to switch to another journal for publication, we will make sure that your document is updated to match the journal’s publishing guidelines.
Medical Writing services
We are here to assist you with any of the documents needed for drug or medical device development:
• Clinical Study Protocol (CSP) or Clinical Investigation Plan (CIP)
• Investigator’s Brochure (IB)
• Patient Information and Informed Consent Form (ICF)
• Clinical Evaluation
• Clinical Study Report (CSR) or Clinical Investigation Report (CIR)
• Clinical Overview and Summary
And if your drug or medical device is already marketed, we can also assist you with:
• Non-interventional Study Protocol
• Protocol for Post-marketing Safety and/or Efficacy Study
• Post-marketing Clinical Follow-up (PMCF) Plan
• Update of your Clinical Evaluation
• Scientific Article