In the rapidly evolving fields of clinical research and Regulatory Affairs, the integration of advanced technologies is crucial for improving efficacy and safety documentation in Clinical Study Reports (CSR). Quantitative Structure-Activity Relationship (QSAR) is one of the leading technologies in CSR generation and processing. Global life sciences companies have implemented QSAR for its efficacy and usability. For more information on QSAR and how it can help achieve compliance in CSR, reach out to a specialist.
Clinical evaluation of medical devices is one of the key steps for receiving the Conformité Européenne (CE), or the European Conformity certification in the European Union (EU) geography. The objective behind clinical evaluation of medical devices is to ensure patient/user safety, drive manufacturers and Notified Bodies (NBs) towards evidence-based decision-making, and at the same time inform them about Post-marketing Surveillance (PMS) activities.
An abstract is a concise summary of a detailed work published separately from the main text. It should, therefore, stand out and be understood without referencing the complete details of the work. A conference abstract is a brief writing, often between two hundred (200) and three hundred (300) words, that serves at least three (03) distinct purposes as explained below. Each conference will have its criteria for the preparation of abstracts. If authors adhere to these rules, their abstracts will have more chances of being accepted.
The analytical performance is described in European Union In Vitro Diagnostic Regulations (EU IVDR) 2017/746 as “the ability of the device to correctly detect or measure a particular analyte.” The analytical performance of any IVD/s is demonstrated based on the analytical performance studies, which are then documented as Analytical Performance Report (APR). The APR plays quite a crucial role in the Regulatory approvals of In Vitro Diagnostic medical devices, as this report is a part of the Performance Valuation Report (PER), which is further used as a conformity assessment.
A Scientific Validity Report (SVR) is a part of the Performance Evaluation Report (PER) under the European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 that documents the scientific validation of the IVDs. The SVR supports the device's conformity assessment and for the same one must consider any relevant published literature and standards. It is usually accompanied by a summary of the results of the assessment.
India is a diverse country with a rich heritage and stories of the miraculous healing of life-threatening diseases with magical powders, talismans, magical shields, etc.
Taking advantage of these belief systems, in recent years, a shift in marketing strategies by industries has been observed. There is a rise in toxic and misleading advertisements, which are flooded in every kind of media, suggesting miraculous healing of diseases and toxicant the minds of people and their emotions.
The adaptation of medical writing bloomed through the ever-evolving medical device industry coupled with the implementation of stringent regulations in the countries. Given the dynamic nature of the medical device industry, it is noticed that manufacturers who aim to place their medical device/s in the market are focusing diligently on medical writing for Regulatory approvals, as it involves drawing up a structured document complying with the Regulatory requirements. Several techniques and tools have been devised and are still being developed to implement effective documents.
The clinical evaluation of medical devices is a procedure for demonstrating the safety and efficacy of the devices. The documentation of the clinical evaluation process is called a Clinical Evaluation Report (CER). The CER holds a significant position when placing or distributing medical devices in the European Union (EU). The report aims to establish the device’s intended benefits for users when weighed against the associated risks.
Drug Development Technologies (DDTs) are methods, materials, or measures that assist in drug development and Regulatory review, as stated in the 21st Century Cures Law. These include biomarkers, clinical outcome evaluations, and other metrics. The Food and Drug Administration (FDA) has created qualification programs for biomarkers, clinical outcome evaluations, and animal models for use in accordance with the Animal Rule to support DDT development activities.
The pharmaceutical and Life Sciences sectors have seen a steady increase in the need for Medical Writing. Patents have been expiring, Regulatory standards have changed quickly, and spending on research and development has been rising constantly. Because of this, the necessity to continuously adapt, produce, maintain, and update medical material has evolved.