Good medical writing plays a crucial role in supporting clinical development. Prism have been closely involved in this area of scientific communications for over 20 years. Some of the key reasons good medical writing plays is so important include: - Facilitating effective communication between different stakeholders in the clinical development process and enhancing collaboration - Streamlining clinical development and regulatory approval through the creation of concise, accurate, and digestible documents such as investigator brochures, CSRs and submission dossiers - Maintaining the scientific accuracy and integrity of the research findings and aids in the transparent reporting of all aspects of the trial and its outcomes - Enabling the ethical dissemination of research findings and supporting the informed consent process by providing comprehensible and unbiased information to study participants - Enhancing the credibility and visibility of the research through the publication of well-written manuscripts, abstracts and posters in peer-reviewed journals and at conferences A company’s reputation relies on how they communicate data and interact with the scientific community, and Prism’s approach to Scientific Communications ensures our clients’ strategic goals and business objectives are met while maintaining the highest scientific standards. Our experience also allows us to maximise the interaction between clinical development teams and medical affairs, to link research and medical education for a consistent flow of knowledge across the product life-cycle.
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Discover the essentials of medical writing with Turacoz Group latest blog. Delve into clinical research, regulatory documents, and beyond. A must-read for those aspiring to excel in medical communication. Read here: https://lnkd.in/dUmsg42G #medicalwriting #typesofmedicalwriting #medcomms #Turacoz
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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. We are here to assist you with: Scientific Publications 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: 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 Additional medical writing services: • Literature reviews • Marketing, training and educational material for patients, doctors and industry employees • Conference materials: abstracts, posters, powerpoint presentations • Meeting minutes (eg. advisory board meetings, etc.) • Editing and review of documents to comply with regulatory or other guidelines • Lay language summaries • Product website content GCP-Service International Your full-service CRO for phase I-IV clinical research with drugs, medical devices and in vitro diagnostic! www.gcp-service.com
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Clinical Researcher @Dr. Reddy's Lab | Clinical Investigation| Clinical Development| Clinical operations| HEOR| RWE| Digital Health| Medical Device Public Health: ICMR | JIPMER| NIMHANS |
🔍Medical Writing vs. Scientific Writing: Bridging the Gap in Communication ⚕ Medical Writing: 📌 Target Audience: 👉 Healthcare professionals, patients, and regulatory authorities. 👉 Communicates clinical trial data, drug information, health guidelines clearly and comprehensively. 📌Subject Matter: 👉Focuses exclusively on medical and healthcare topics. 👉Includes documentation on new medicines, drug safety, patient education materials, and regulatory submissions. 📌Regulatory Requirements: 👉Strict adherence to regulatory guidelines, particularly in drug development and clinical trials. 👉Ensures documents meet rigorous standards to guarantee safety and efficacy of medical products. 📌Expertise: 👉Authored by professionals with medical or healthcare backgrounds. Requires in-depth knowledge of therapeutic areas, drug development processes, and regulatory requirements. 👩🔬 Scientific Writing: 📌Target Audience: 👉Targets scientists, researchers, and experts across various scientific fields 👉Aims to share discoveries, innovations, and technical insights among peers. 📌Subject Matter: 👉Covers a broad spectrum of scientific topics, including but not limited to medicine. 👉Involves highly technical content suitable for publication in scientific journals and academic forums. 📌Regulatory Requirements: 👉Adheres to standards of accuracy and peer-reviewed publication norms. 👉Guidelines may vary by discipline but generally focus on scientific integrity and advancement of knowledge. 📌Expertise: 👉Written by researchers and experts from diverse scientific disciplines. 👉Requires deep understanding and proficiency in specific scientific fields to contribute to the body of scientific knowledge. 📍 In a Nutshell: Understanding the Differences: 👉 Scientific and medical writing share similarities but cater to distinct audiences, topics, and regulatory frameworks. 👉 Medical writing serves as a specialized subset of scientific writing, crucial for effective communication in healthcare and regulatory settings. 🔗 Read more: https://lnkd.in/gR4bUyag #ScienceWriting #MedicalWriting #medicalwriter #scientificwriter #Healthcare #PatientSafety #HealthInnovations
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HEOR medical writing uniquely integrates medical science and economics to inform healthcare decisions 🧬. It's crucial for evaluating the cost-effectiveness of treatments, influencing both policy and clinical practice. 1️⃣ HEOR medical writing supports with communicating the economic impact of healthcare interventions, guiding policy makers and stakeholders. 📉 2️⃣ The demand for HEOR medical writing as a career option is rising, driven by the need to optimize healthcare expenditure and ensure value-based care. 🚀 Could the growing focus on HEOR medical writing lead to a transformation in how we approach healthcare sustainability and efficiency? #HEOR #HealthEconomics #pharma #healthcareindustry #patientaccess #medicaldevices #biotechnology #futureofhealthcare #digitalhealthcare #healthtech #hta For more in-depth information, visit the original article on Syenza's website. https://lnkd.in/d2evKMT2
The Exciting World of HEOR Medical Writing: A Unique Blend of Science, Economics, and Impact - Syenza
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Client centricity- learn it from this medical writing team! In December 2023, we got a strange request from a pharma client that they wish to publish their phase 4 safety results at the earliest. The study was just complete, clinical study report was in process and my medical writing team were handed over a bunch of TLFs and protocol and asked to write the manuscript and submit it in a month’s time. These are the top 5 strategies my team employed to meet this fast track publication challenge. 1. Working very closely with the client statistical team and clinical team to get the interpretations correct. The team provided several valuable inputs to the client teams during this process- after all, medical writers come with a good research background themselves! 2. Keeping very tight project deadlines for both internal team as well as client team for review and approval. Extremely well planned project management. 3. Flagging the potential concerns in the study to the client adequately and appropriately so that they could take corrective actions. This is an advantage of having trained and experienced medical writers who have helped many in addressing journal review comments. 4. Resolving all the author comments over team meetings- there were several occasions when the team educated the client team and authors about why certain information is necessary and had to be included as per guidelines. They stood by what is right, scientifically and ethically! 5. Last but not the least, choosing the right journal. This is a very critical step in publications especially when you have a target to get something published in 6 months. I am really proud of my team for their stupendous efforts to getting this phase 4 study published in a peer reviewed journal in less than 6 months- a journey that started somewhere in mid December with manuscript writing to its submission in January and after addressing all the comments in April, it is now finally published! Well done team- Dr. Anuradha Chatterjee, Somdatta Mukherjee, Pavana Goury Sistla Dr Namrata Turacoz Group Turacoz Healthcare Solutions Vasudev Tribhuvan Amey Shrotri Rajneesh Sharma Nitesh Goel Ashish Pandey Anshu Chauhan Article: Shivnitwar S K, Gilada I, Rajkondawar A V, et al. (May 23, 2024) Safety and Effectiveness of Liv.52 DS in Patients With Varied Hepatic Disorders: An Open-Label, Multi-centre, Phase IV Study. Cureus 16(5): e60898.
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The Power of Scientific Medical Writing: Bridging Science and Communication In the rapidly evolving world of healthcare and medicine, the role of a scientific medical writing is more crucial than ever. It translates complex scientific data into clear, compelling, and accurate information that can be understood by diverse audiences—from healthcare professionals and researchers to patients and regulatory bodies. Why is Scientific Medical Writing Important? Clarity and Precision: Scientific medical writers ensure that intricate research findings are presented in a precise and accessible manner, eliminating ambiguity and enhancing understanding. Regulatory Compliance: They play a key role in preparing regulatory documents that comply with stringent guidelines, ensuring that new drugs and treatments are approved efficiently. Education and Awareness: By creating educational materials, scientific medical writers help bridge the gap between cutting-edge research and clinical practice, academicians ,empowering healthcare professionals with the knowledge they need to provide the best care. The Impact of Scientific Medical Writing - From advancing medical knowledge to improving patient outcomes, scientific medical writing is at the heart of the healthcare communication ecosystem. Whether it's drafting a groundbreaking research manuscript, developing regulatory submissions, or creating patient education materials, medical writing plays a vital role. #ScientificMedicalWriting #MedicalWriting #HealthcareCommunication #ClinicalResearch #PatientEducation
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CORE Tools for Clarity Anyone that works in healthcare knows it’s a fast-paced, complex field. And the A-team rises to the challenge, daily. One thing that’s crucial to our work is the CORE Reference guidance. This international standardised resource gives us an extra pair of eyes, helping our medical writers navigate guidelines, as they create clinical study reports (CSRs). The guidance includes detailed content suggestions, meaning less modifications prior to publication. It also enables us to: ✔️ Enhance clinical trial transparency ✔️ Improve upon internal pharmaceutical CSR templates ✔️ Address any ambiguity in the ICH E3 CSR guideline ✔️ Improve data protection by highlighting privacy-related risks Curious how the CORE Reference guidance can help you with your medical writing? 👉 https://lnkd.in/eTb6yWmE #AlchemyMedicalWriting #MedicalWriting #COREReferenceGuide
Core Reference: Guidance for Authoring Clinical Study Reports - Alchemy Medical Writing
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