Back to Main Menu
social link
social link
social link

EMA and US FDA requirements for non-clinical development of radiodiagnostics

   |   

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

Rare Disease: An Overview of STXBP1

   |   

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

Raising the standard of excellence in eSubmissions

   |   

ClinChoice is a CDISC registered solutions provider and has been a CDISC gold member for 20+ years. 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 your NDA/BLA. … Continued

Clinical Trials in Rheumatoid Arthritis: A Statistical Insight

   |   

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

Pharmacovigilance: Literature Monitoring Best Practices

   |   

Safe and effective use of health products is a key objective of pharmacovigilance. Information is provided about the safety of these substances to patients, healthcare providers, and the general public as soon as possible. Pharmacovigilance includes reviewing the development, management, and introduction of pharmaceuticals. It is probably the most tightly regulated part of the pharmaceutical … Continued

Regulatory Submission of Generic Drugs in Canada – Best Practices

   |   

The development of a generic drug is very different from that of an innovative drug with a novel chemical composition. It must be sufficiently comparable to the latter to determine whether a generic drug is therapeutically equivalent to an innovator product. To be market-effective, drug companies must develop generic drugs that achieve the same level … Continued

What’s it like working for ClinChoice?

   |   

ClinChoice strives to set the Standard of Excellence, but such ambition is not achieved alone. The largest contributors to ClinChoice’s success are the people that help support the company’s mission. Watch now and take a look at why ClinChoice’s longstanding employees value the company just as much as ClinChoice values them.  

DIA 2022 Recap

   |   

After many months of planning and anticipation, DIA 2022 in Chicago finally arrived. For the first time in over 2 years, colleagues, partners, and friends gathered at the Drug Information Association conference in person. And then, seemingly in the blink of an eye, the conference was over! Here are some key takeaways from ClinChoice:  Technology: … Continued

Leveraging Technology Effectively in Clinical Research

   |   

Clinical research is a rapidly evolving field. As technologies improve and advanced capabilities become accessible, new tools, methodologies, and processes also emerge. Depending on the area of research, size, target demographics, and other factors, these new technologies can help improve efficiency, accuracy, speed, and the quality of data gathered and analyzed. A key element of … Continued

Rare Diseases

   |   

How rare are rare diseases? The Orphan Drug Act defines a rare disease as a disease or condition that affects less than 200,000 people in the United States.