Biostatistics is the study of uncertainty and determining how to measure it and how to react based on the results. Medical Device trials face the following uncertainties: Safety Problems Unexpected treatment effects/safety issues High variance Effects in secondary endpoints/subpopulation Reducing uncertainty in the planning phases of device development can eventually reduce timelines, and inevitably, costs.…
Oncology is a main area of focus for many pharmaceutical and biotechnology companies around the world. The facts about cancer are startling: cancer claims over 7 million lives each year and the number continues to grow. It is no wonder why drug development companies are focusing on this complicated therapeutic area which has over 450…
The FDA has released a position statement on study data standards for regulatory submissions. According to recent legislation in the U.S., the FDA “will develop guidance for the industry on the use of CDISC data standards for the electronic submission of study data in applications”. The statement goes on to say that the FDA will…
CROS NT has expanded its life sciences technology portfolio by joining the DATATRAK Connect™ Program – a program which allows for extended service offerings for the drug development process with the goal of reducing study costs and furthering business development objectives. Under this partnership program, CROS NT can provide DATATRAK’s clinical trial technologies including Electronic…
