Category: Blog

The world is progressing rapidly with advanced technologies and customization in almost every sector to meet human needs. In the healthcare sector, manufacturers of medical devices are actively involved in developing individualized products based on a patient’s needs. In some instances, over-the-counter/mass-produced medical devices, especially implantable devices, may not meet the specific patient’s requirements. Hence, … Continued

Project FrontRunner is an Oncology Center of Excellence (OCE) initiative that encourages sponsors to consider when it is appropriate to develop new cancer drugs for advanced or metastatic disease in an earlier clinical setting. Currently clinical trials are designed to include patients who have run out of treatment options and are in their late stage … Continued

In August of 2023, the Food and Drug Administration (FDA) released a final guidance document that serves to assist Institutional Review Boards (IRBs), Investigators and Sponsors in their roles and responsibilities related to the Informed Consent process. This document serves as a finalization to the FDA’s draft guidance issued in July 0f 2014 entitled “Informed … Continued

MDR transition Regulation (EU) 2017/745 on medical devices (MDR) has replaced the dated Medical Device Directive 93/42/EEC (MDD) to help increase overall compliance and standards for the quality and safety of medical devices marketed in the EU as well as to raise public awareness and ensure continuous monitoring of product safety and performance throughout the … Continued

Functional Service Provider (FSP) models can enhance workflows while speeding up timelines and remaining cost-effective. ClinChoice has over 27 years of experience helping customers find the FSP model that’s right for them. Watch this video to learn more and talk with a specialist today to find a flexible FSP model that fits your current needs. … Continued

New Intern (NI): Hello, Senior Medical Writer – today’s my first day! I’m really excited to know the skills one needs to acquire for writing related to medical devices! Senior Medical Writer (SMW): That’s great, and welcome! We’re happy to have you, and I hope I can answer any questions you might have. But I … Continued

Pertaining to the radiodiagnostic agents, there are few changes in the non-clinical requirements between the EMA (European Medical Agency) (EMA/CHMP/SWP/686140/2018) [1] and US FDA (United States Food and Drug Administration) (Docket Number: FDA-2017-D-5297, Document ID: FDA-2017-D-5297-0007) [2]. The requirements are not the same between them; therefore, for someone who needs to register a product through … Continued

STXBP1 is a gene that encodes a specific protein called MUNC18-1 which is essential for synaptic transmission1. The MUNC18-1 protein is a key protein that helps organize the SNARE-complex which is responsible for mediating vesicle fusion with the cell membrane or other vesicles2. A mutation in the STXBP1 gene can result in impairment of psychomotor … Continued

ClinChoice is a CDISC registered solutions provider and a CDISC platinum member with a long history working alongside CDISC. As an early adopter and contributor to CDISC standard development, ClinChoice ensures your clinical data is fully validated and submission ready. Our extensive knowledge and active participation in the field drives efficiency and accuracy while submitting … Continued

An autoimmune inflammatory disorder, Rheumatoid arthritis (RA), develops when the body’s immune system attacks healthy cells, resulting in inflammation. RA mainly affects the joints, usually more than one joint simultaneously. As a shock absorber for joints, RA damages the cartilage by uncontrolled inflammation. The result is deformed joints over time. Finally, the bone itself starts … Continued