Reaching approvals with Viedoc

Whenever testing an investigational product, the end goal is almost always the same — approval. Gaining authorization from a regulatory body the product access to the market and, most importantly, reach the patients in need, helping create a healthier world.

Every treatment must undergo rigorous testing to reach each clinical phase. The farther the medication goes in this process, the higher the stakes. It can easily be argued that Phase III is the most rigorous stage before approval is reached.

Here are two examples where research has resulted in market approval. The common factor between these two studies is the choice of eClinical solution. The data in the studies were collected using Viedoc. To date, over 2000 trials have used Viedoc, and hundreds of these have been phase III.

Defibrotide, sold under the brand name Defitelio, is used to treat veno-occlusive disease of the liver of people having had a bone marrow transplant. By preventing blood clots, this drug increases the safety of the patients who have undergone the hardships of cancer treatments. Defibrotide has, after clinical testing using Viedoc, received approval from EMA (2013) and FDA (2016).

Another example of medical treatments reaching approval status is Lokelma approved for the treatment of adults with hyperkalemia (elevated level of potassium (K+) in the blood serum) often in patients with chronic kidney disease and for those who take common medications for heart failure. This approval addressed a long-standing need these patients had and was based on three double-blind, placebo-controlled trials and in two 12-month open-label clinical trials in adult patients with hyperkalemia.

Viedoc has developed eClinical systems since 2003; helping life science companies around the world bring therapies to market faster.

If you want to find out more click here to request a demo on how Viedoc helps any trial ensure data is collected easily, quickly and safely.