A critical part of clinical trial conduct is providing medical guidance by the responsible medical monitor to investigative sites and various operations team members, including, but not limited to, clinical research associates and clinical study managers.
Assessing the satisfaction of healthy volunteers is important because of the vital role they play in the drug development process via assessment of safety of dose administration and pharmacokinetic characterization of the absorption, metabolism, and distribution of compounds in the body.
ERT’s announcement of its intention to acquire PHT makes more than sense. And when speaking with the companies’ CEOs, Jim Corrigan and Philip Lee respectively, the potential for success is greater than any challenges the current clinical trials market could throw their way.
It seems only yesterday that the future for European pharma was personalized medicine. The European Union first gave the term official status in a formal paper in 2008, entitled a Renewed Vision for the Pharmaceutical Sector, in which the Commission included a section on ‘Towards more personalized medicines’.
That's because the discussion shifted away from one focused on changing monitoring methods and doing reduced source document verification (SDV) to 'intelligent monitoring.'
PwC Health recently did some studies on the New Health Economy that encompasses our society today.
The five-year figure doesn't always determine which cancer types are most commonly being studied in late-phase trials.
Medidata took a look at how eCRF design complexity correlates with the number of migrations performed while a study is actively collecting subject data.
The current regulatory environment of a particular country plays an important role in the geographic selection. For India, it is very relevant because of problems in clinical trials approval and conduct issues during last few years.
Recent advances in proteomics, genomics and metabolomics have enabled us to understand the molecular basis of disease at both the diagnostic and treatment levels.