Regulatory Intelligence of Cosmetics for July through September of 2023.
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Blog
Custom-Made Medical Devices: Are You C...
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
Blog
Project FrontRunner: Advantages in dir...
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
Blog
Informed Consent: Guidance for IRBs, C...
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 This document serves as a finalization to the FDA’s draft guidance issued in July 0f 2014 entitled “Informed … Continued
Blog
New EU MDR compliance dates: Impact as...
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
Press Release
ClinChoice Partners with Anju to Simpl...
Ft. Lauderdale, FL June 26, 2023 – Anju Software, a leading life science technologies provider, announced that ClinChoice is expanding its footprint with TrialMaster and Anju’s eClinical Suite. The partnership allows ClinChoice to deliver a full suite of cost-efficient and adaptable eClinical solutions providing impactful insights and accelerated results. “With our acquisition of Cromsource, we … Continued
Blog
Our one-of-a-kind FSP Capabilities
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
Blog
First Time Into Medical Writing for Me...
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
Press Release
ClinChoice Acquires CROMSOURCE, Expand...
Philadelphia, USA; Shanghai, China; and Verona, Italy. March 01, 2023 – ClinChoice Medical Development is pleased to announce its acquisition of CROMSOURCE S.r.l., an ISO-certified full-service contract research organization with its corporate headquarters in Verona, Italy and its US headquarters in Cary, NC. CROMSOURCE has operational subsidiaries in the US and seven countries throughout Western … Continued
eBook
Gut Microbiota: A Disregarded Subject ...
The microbiome is coevolved in humans and healthy individuals. The microbiome is said to be in the symbiosis or eubiosis state, in which the microbiome is intact with its functions, such as digestion and absorption of food and xenobiotics, eliciting the immune response, protecting the body from external microorganisms, and producing the essential metabolites required … Continued
Blog
EMA and US FDA requirements for non-cl...
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
Blog
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
Blog
Raising the standard of excellence in ...
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
Blog
Clinical Trials in Rheumatoid Arthriti...
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
Blog
Pharmacovigilance: Literature Monitori...
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
Blog
Regulatory Submission of Generic Drugs...
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
Press Release
ClinChoice Raises $150 mm Series E Rou...
ClinChoice Raises $150 mm Series E Round Financing, Further Strengthening its Global Services Capabilities PHILADELPHIA, July 5, 2022 /PRNewswire/ — Recently, ClinChoice announced the successful completion of its $150 mm Series E round financing. The investment was led by Legend Capital, and co-invested by Taikang Life Insurance, Sherpa Healthcare Partners and existing shareholders, including Lilly Asia Ventures and Apricot … Continued
Blog
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:Â Technology: … Continued
Blog
Leveraging Technology Effectively in C...
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
Press Release
ClinChoice Names Calyx Preferred Partn...
Depth and diversity of Calyx scientific and technical teams’ experience extended to ClinChoice’s worldwide clients NOTTINGHAM, England and MORRISVILLE, N.C., March 7, 2022 /PRNewswire/ — Calyx, the eClinical and Regulatory solutions and services provider relied on for solving complex data challenges in clinical research, today announced it has been named a preferred provider of medical … Continued
Blog
Why should programmers join ClinChoice...
We have a diverse client base who develop lifechanging medical devices, vaccines, and other products. Our enriching work environment offers programmers exposure to a wide range of clients, scientific areas, geographic settings, and a highly talented, multicultural team. Watch now to learn more about our industry-leading team, exceptional leadership, remote or hybrid work model, and … Continued
Blog
What makes Clinchoice successful?
People have always been the cornerstone of success at ClinChoice. Led by strong leadership that gives a depth of experience and direction to advancements, we prepare the next generation of leaders to take on new challenges with skill and integrity. Mahesh Mudnur – President, Asia-Pacific, elaborates on how ClinChoice has been successful for the last 26 years. … Continued
Blog
How do we engage with our clients?
For over 26 years, ClinChoice has been proudly providing deep insights that help leading medical device and life sciences manufacturers bring lifechanging products to market. Mahesh Mudnur, President – Asia-Pacific, and Sridhar Punniamurthi, Director – Statistical Programming, expand on how we focus on our client’s needs and deliver projects on time with quality. Watch now to learn … Continued
Blog
Get to know ClinChoice
In this brief video, Mahesh Mudnur, President – Asia-Pacific, delves into ClinChoice’s past and present. With centers in China, the US, Philippines, and Japan, and over 2200 professionals worldwide, our agility compliments our culture of client service and success. Watch now to learn about our commitment to reliable partnerships and providing deep domain experience in … Continued
Blog
Answering Questions Surrounding Custom...
Technological advancements in manufacturing make it possible for manufacturers to commercially produce personalized custom medical devices (CMD) much faster. The advancements, when coupled with regulatory changes, can be confusing. That’s why we’ve created this brief review to help clarify the most critical points within recent European Medical Device Regulation (MDR) updates. MDR Article 2(3) defines … Continued
Press Release
ClinChoice Opens Canadian Development ...
ClinChoice Opens Canadian Development Center – Expanding its North American Capabilities PHILADELPHIA and SHANGHAI, July 22, 2021 /PRNewswire/ — ClinChoice, a leading global, midsize, and rapidly growing contract research organization (CRO) focused on the delivery of superior quality, highly efficient, and effective clinical research services across the development continuum in Pharmaceutics, Vaccines, Medical Devices, Consumer … Continued
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