Tag: regulatory writing

Bibra Toxicology Advice and Consulting

Posted on by Valentina Rosa
Bibra Toxicology Advice & Consulting
Bibra Toxicology Advice & Consulting

In the TRA360 Regulatory Writing practice, we are always on the lookout for companies that can add value in this space. Bibra Toxicology Advice and Consulting is one such company. They are a small company based in the UK. Bibra provides advice for toxicology during the process of clinical trials.

Bibra’s team of 15 toxicologists has a combined total of over 250 person years of experience in this field. All of their consultants are experts in the field of toxicology. They have completed many engagements for different customers across a broad range of disciplines. What about governmental compliance work? Bibra has a relationship with many governmental regulatory agencies, in the UK and internationally. Recently, their team worked with an unnamed international industrial chemicals manufacturer on compliance work. They worked with them to adhere to the United States Toxic Substances Control Act (TCSA) in collaboration with the Natural Resources Defense Council (NRDC). This compliance work can be found in the Recent Projects section of their website. Their team always meets their deadlines, an essential for success in clinical trials.

If you need toxicology advice for your business be sure to check out Bibra! Let us know how everything turns out @TRA360!

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!

When Science, Technology, and Social Media Mix

Posted on by Valentina Rosa
Would you take the world’s first digestible digital pill?

What do you get when you add science, technology, and social media together? Some might think a really cool iPhone, or an app that allows self-diagnosis instead of a doctor. Although that would be pretty cool, earlier this week, Mashable reported the first-ever FDA-approved digestible digital pill.

This new pill comes equipped with a microchip roughly the same size as a particle of sand, which can be embedded in drugs to monitor patients’ response to various treatments and medical conditions. One of the digital pill’s most valuable attributions is the ability to track how well (or poorly) the drug is reacting to and ultimately working with the patient’s system through an embedded sensor that contains small amounts of magnesium and copper. Mashable describes, “When a patient swallows it, the pill generates slight voltage which responds to digestive juices. The voltage sends a signal to a patch worn by the patient, which transmits relevant information to a health care provider’s mobile device.”

As a life science company with a focus on pharma and biotech, we are constantly exploring new advancements in health care and bio. Social media has reached new levels since the rise of the Internet and social networks. However, very few have attempted to mix the two fields to create what could be a breakthrough in digital medicine. Yes, a digestible digital pill could potentially help medicine operate more effectively because results are coming back straight to the source, however, we won’t really know until we try…would you?

Tweet to us @TRA360 or comment below why you would or wouldn’t try the first-ever FDA-approved digestible pill! 

Quanticate

Posted on by Valentina Rosa
Quanticate
Quanticate

Imagine being the world leader in your field with a 93% return rate of customers—amazing right? Well, you don’t have to imagine this if you’re Quanticate since it’s their reality.

Quanticate is the world’s largest Global Clinical Research Organization (CRO). They focus on data services for their customers. According to their website the company provides “clinical data management, biostatistics, clinical programming, medical writing, pharmacovigilance services and remote monitoring approaches.”  Their service saves their customers over 30% of the cost to perform the services themselves. They serve every stage of clinical trials from Phase I to Late Phase, as well as PK PD Modeling. Across the board, Quanticate provides the greatest expertise in all of their fields of service, and are compliant with all standards.

How could you go wrong with a company that is a world leader and will save you money? You can’t, and their customers have discovered this too. If you’re running a clinical trial or need to use the services of a CRO, Quanticate is worth serious consideration. Go on, become part of the 93% of customers that come back for more! Be sure to let us know what you think.