CASE STUDIES


 

case-study2Harnessing the Clinical Research Professional, One Size Doesn’t Fit All

 

Effective clinical trial monitoring requires the selection of appropriate talent. As has been widely mandated by U.S. and international regulatory agencies and vastly advocated by human rights protection groups, sponsors of clinical investigations are required [emphasis added] to provide oversight and to ensure the protection of the human subject for ethical, moral, safety, and legal reasons, to name a few. Through the years, one integral component of protecting the human subject has been the practice of monitoring clinical trials by clinical research professionals.

Vetting clinical research professionals for clinical trial fit oftentimes occurs under pressure and close to site initiation visits. Selecting talent under pressure to meet deadlines has the potential of jeopardizing the safety of the human subject and the outcome of the clinical trial. To mitigate risk, some options exist, including the following tactics:

Not all are created equal.
Ensure the clinical research professional has vast experience in the therapeutic indication of the
clinical trial. Beyond experience, the clinical research professional should have a particular skill-set
to deliver “absolutely” outstanding results, e.g., communication skills, technology skills, negotiation
skills, firm understanding of GCP and ICH Guidelines, and knowledge of regulatory requirements.
Bottom line:

  • LITMUS designed and developed a behavioral assessment; and
  • LITMUS screened all candidates for clinical trial fit against the job description and protocol.

LITMUS Value Driver: Increased visibility to the competencies of potential candidates.

One size doesn’t fit all. Ensure that you ask for references even when a clinical trial professional is referred to you by word of mouth. The clinical research professional may have years of experience in specific therapeutic indications but does he or she have the required competencies to effectively monitor your clinical trial? Bottom line:

  • LITMUS narrowed down the candidate pool and then contacted references to better assess a candidate’s strengths and areas of opportunity; and
  • LITMUS made hiring recommendations based on competency profiles.

LITMUS Value Driver: Increased reliability of clinical trial fit with the clinical research professional’s competencies to effectively monitor the clinical trial.

To learn more about these tactics or to receive additional information, please contact us at: LITMUS