The Pulse

The Pulse

Patient Centricity: A positive shift for the patient experience

April 30, 2018

Sponsors’ heightened awareness of the importance of patient engagement in the design and execution of research studies has led to the discovery of crucial information about participation pain points. The information often reveals huge disconnects in what patients prefer and what they experience. Resolving these disconnects can have a significantly positive impact on patient recruitment.

The Pulse

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.

The Pulse

A Successful Clinical Trial Begins with the Study Start-Up Phase

March 12, 2018

The study start-up phase sets the tone for a clinical research trial and is crucial to the overall success of a program. The critical nature of this phase places significant pressure on all stakeholders. The strength of the relationship between the site and CRO during study start-up is an important factor in creating a successful study outcome. Rather than a customer and vendor relationship, sites and CROs should strive to develop strategic alliances, partnering seamlessly through an entire clinical study and beyond. The study start-up stage offers ample opportunities for sites and CROs to establish the foundation of a trust-based relationship.

The Pulse

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.

The Pulse

Establishing Long-Term, Mutually Beneficial Relationships

February 12, 2018

The complexities involved in conducting clinical trials extend well beyond clinical trial protocols and study design and into a realm where we often find the greatest return — relationships. The relationship between a research site and a CRO is particularly unique and gaining more attention in the clinical research industry.

The Pulse

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.

The Pulse on Study Conduct

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.