On November 14th, 2018, we celebrate World Diabetes Day (WDD) in remembrance of Sir Frederick Banting, who co-discovered insulin, along with Charles Best in 1922. According to the International Diabetes Federation (IDF), World Diabetes Day was created in 1991 IDF and the World Health Organization in response to increasing concerns about the escalating health threat posed by diabetes to a growing number of people.
Tomorrow, on Saturday, November 10th, we will celebrate World Science Day for Peace and Development. According to the United Nations Educational, Scientific and Cultural Organization (UNESCO), this is a day which highlights the importance of science in and for society, as well as establishing that science, peace and development and permanently interlinked.
On Thursday, November 8th, 2018, we celebrate World Quality Day. This day was designed to increase worldwide awareness of the important contribution that quality makes toward both organizational and national growth as well as prosperity.
After being in the draft stages for approximately three years and continuing to receive industry feedback, the FDA CDER has just released final Guidance for Industry Title Testicular Toxicity: Evaluation During Drug Development in October 2018. There are numerous challenges with conducting multi-center clinical trials focusing on testicular toxicity and yet remaining within the realm of guidance from the FDA per their statement:
Immunity at the heart of the matter
Surgeons worldwide perform more than 100,000 solid organ transplants annually, with successful transplantation of hearts, lungs, livers and kidneys saving and changing thousands of lives. After complex surgery, the risks of infection and organ transplant rejection mean the patient’s fight for recovery starts immediately; even anti-rejection medication can lead to serious adverse effects. Eurofins’ work in immunity is helping to change patient recovery outcomes.
For those that have been in the industry for awhile, we have all heard the saying "No one gets fired for choosing "Company X"! You can insert the company name of your choice. In my 30 years in clinical research, I've heard this in reference to a couple of companies.
The question that needs to be asked is, are you and your organization making this statement based upon:
- Consistent commitment to quality and compatibility?
- Extensive global capabilities?
- Reliable service year after year?
Or is it being made due to:
- Historical relationship – better to stick with the devil you know?
- Understaffed/overworked vendor management personnel, challenged with finding best in class in solution?
These are very real phenomena that I'm sure we have all experienced at one time or another. But if you are making the statement due to the latter, they all indicate that your clinical development team may be missing out on receiving Best in Class central laboratory solutions.
When choosing a central laboratory, here are a few factors you should look for:
- Quality Systems
- Global Standardization
- Logistics Services
- Data Management and IT Services
- Additional Services
At Eurofins, we provide seamless, end-to-end solutions to help clients progress through the drug development cycle through a single, experienced provider. From compound discovery and clinical research through the manufacture and release of commercial product and post-approval/marketing, our integrated solutions deliver the most comprehensive range of services. Our state-of-the-art analytical technologies and expansive geographic reach enable us to support our clients’ specialized testing needs and stringent quality and safety requirements.
And, with Eurofins being recognized for the 7th year in a row – every year since the inception – of the CRO Leadership Award (1 of only 2 laboratory providers able to state that fact), shouldn't the statement read:
Eurofins Central Laboratory, a member of the leading international Eurofins Scientific Group, announced today that it will extend its capabilities in global Kit Packing and Distribution Services by opening a Good Manufacturing Practices (GMP) compliant Kit Packing and Distribution facility in Louisville, KY, US.
Tags: Kits & Logistics