In principle, the electronic data capture (EDC) process is no different for a trial of a biopharmaceutical than it is for a small molecule drug – data must be securely collected from multiple sites in as efficient a way as possible.
However, the economics of the biopharmaceutical development process make the timely collection of data particularly important for trials involving such drugs according to Jeremy Edwards, Exco InTouch general manager in North America.
He told Oustourcing-pharma.com “the area where we tend to see a difference between biopharmaceutical and small molecule trials comes from the fact that biopharmaceutical companies often have smaller pipelines which depend on external funding from Phase to Phase.”
This means these trials “run to more critical time points with a smaller number of patients and more restrictive budgets” Edwards continued, adding that as a result biopharma sponsors “are usually ahead of the masses when it comes to designing trials to include engagement and electronic data capture from the outset.”
In contrast the rules governing EDC do not differ for biopharma and small molecule drug studies according to Edwards, who said: “The regulatory oversight for patient communication and data capture services are the same, whether for a biopharmaceutical or a small molecule drug trial.
“We believe that the protection of all patient data is of vital importance, and that is why, since our inception, we have focused heavily on compliance with global data regulations.”
He added that: “It is safe to say that the biopharmaceutical and the pharmaceutical companies alike are trending more towards electronic capture of patient reported data, realizing that paper is no longer the desired route.”