Tag: regulatory consulting

CIRION Contract Research Laboratory

Posted on by Valentina Rosa

 

CIRION Central Laboratory
CIRION Central Laboratory

The Medical Writing practice at TRA360 looks for companies that can add value to our clients. CIRION Central Laboratory is a mid-sized Canadian-based contract research laboratory that helps biotech and pharmaceutical companies through the clinical testing process. Their goal upon establishment was to design an organization that can offer companies resources for their clinical trials and expertise in the sciences.

But what do they do? According to the CIRION website they “offer the complete range of services of a larger organization with the added personalized attention and dedication you expect for your projects, regardless of their size.” They also provide services in the development of assays and have the capability to validate per GLP standards. In addition to GLP , they are are also compliant with and adherent to GCP regulations. In addition, CIRION is accredited by the College of American Pathologists (CAP), as well as the Center for Disease Control (CDC). Do they send out their work, or do it on site? CIRION has the ability to run all of their tests and assays in-house which ensures the consistent quality across their testing. This also allows for cost saving and rigorous control of the tests being done.

What do they have for experience? The scientist that work with CIRION all have a science background and a knowledge of clinical logistics for the benefit of the customer. CIRION’s talent pool includes scientists that have experience in biologistics, biosimilars, biomarkers, biochemistry, cell biology, immunology, microbiology, and molecular assays. Each project is assigned a project manager with the appropriate qualifications for that project. This ensures that the quality of their projects are up to the best of their ability. 

Are you in the market for a company to help you with your clinical testing? CIRION Central Laboratory could help you. Let us know what you think @TRA360!

Study Shows Online Training More Effective for Regulatory Compliance

Posted on by Valentina Rosa
Online training is taking over the Regulatory Affairs industry

A recent study from Enhanced Online News (EON) shows that in comparison to other techniques, regulatory affairs online training is the most efficient and effective method. Today, online training helps build clearer accountability and shows measurable return-on-investment metrics.

Why online training?

In contrast to traditional regulatory affairs training, online technology allows regulatory teams to “easily monitor which employees have completed all necessary compliance training”. For instance, digital tools test employees on their knowledge of SOPs, policies and new processes. In general, those who have undergone digital regulatory compliance training have reduced their compliance problems in recent years. On the other hand, companies requiring traditional training have had more difficulties overall overcoming various compliance issues.

The modern world of technology is ever-changing and constantly developing. With this change in technology comes the evolution of digital training for industries around the world.

Do you think online training for regulatory affairs is the most effective training method? Comment below and let us know!

RegLink and RAPS Partner to Create Global Drug and Device News

Posted on by Valentina Rosa
RAPS and RegLink collaborate

Attention, Regulatory Affairs Professionals! RegLink and RAPS (Regulatory Affairs Professionals Society) are teaming up to create a news system which will cover international regulatory development coverage. In a recent article about the collaboration, RegLink partner, Louise Zornoza exclaimed, “both organizations are focused on the same goal – keeping regulatory professionals informed.” And that is exactly what these professionals can expect to see in the near future.

RegLink, an increasingly popular news source for drugs, biologics, and medical devices, covers the regulatory and health technology field. On the other hand, RAPS has over 11,000 members worldwide and recently released a new interactive website. Their website also features an updated electronic magazine, Regulatory Focus.

With two major powerhouses in the Regulatory Writing Affairs industry pursuing this new endeavor, international industry news will be available at anyone’s fingertips. What do you think about this collaboration? Would you like to see more collaboration occuring in the industry? Comment below and let us know or tweet to us @TRA360! 

Boston Entrepreneurs’ Network Meeting: Legal Issues and MORE!

Posted on by Valentina Rosa
ENET with Christina Inge, Tim Schmidt and Ryan Connors
ENET Advisory Board members Christina Inge and Tim Schmidt with TRA360’s Ryan Connors

This past week was ENET’s (Boston’s IEEE Entrepreneurs’ Network) monthly meeting on legal and tax issues. I guess there’s no big reason to learn about those when starting a company. Who likes keeping their hard earned money anyways? Did you catch that?

Decisions made in the early stages of forming a company are critical to the company’s future. From forming as an LLC, C corp or S corp, there are pros and cons that must be fully understood to prevent things such as double-taxation (don’t we pay enough?), unnecessary liabilities, and future investments. Now all of these can’t be laid out in a single article, and even so I’m not qualified to do so. I happen to know a few people that would be qualified and ENET is the place to meet them. It’s good food for thought.

The next meeting will be January 3rd from 7:00 – 10:00PM  at the Foley Hoag Emerging Enterprise Center, 1000 Winter Street, Suite 4000 (north entrance), Waltham, MA and will be on Creating a Technology Services Company. The meeting is sure to be an exciting one and will feature none other than Valentina Rosa, founder & CEO of TRA360, and a panel of seasoned entrepreneurs. If you’re interested in the topic or just in networking with the best group of professionals in Boston, ENET is the place to be.