The Pulse on Study Conduct

eConsent: The benefits and impact on patient awareness and understanding

April 2, 2018

No one can dispute the impact of technology on clinical research. eConsent interactively educates study participants on the study risks, benefits and responsibilities of trial participation, while clinical researchers have had to discard archaic means of data collection that imposed parameters on time and convenience, in lieu of electronic-based systems that truly engage and enlighten the modern study patient.

Evaluate New Investigative Sites Holistically

March 5, 2018

Investigational sites must be evaluated based on each element of contribution to form a fully dimensional picture for study consideration. Some sites excel at recruitment, but lack therapeutic expertise. Some sites with inexperienced staff have tactical/logistical expertise. Those sites lacking in some areas may tip the scales in their favor with other valuable strengths. We may miss out on good sites if we do not consider the entire picture.

Difficult Decisions are the Most Important Decisions

February 5, 2018

At some point, we have all had to make hard decisions to remedy an issue impacting an important process. Whatever the circumstance surrounding the decision, personal or professional, borne of opportunity or duress, the decision will create some degree of hope or discomfort for those involved.

Educate yourself on new therapeutic areas

January 8, 2018

Medical knowledge for the vast assimi­lation of clinical research guidelines is necessary for anyone entering the field. The diverse regulatory landscape requires us to stay abreast of changes that impact patient safety data. It is a multifaceted learning process with educational requirements that vary by role. We should never expect anyone to have every answer, or to know everything about a protocol/therapeutic area. That sets an unreal­istic standard that undermines performance.