Jayesh Chaudhary is a co-founder and CEO of Vedic Lifesciences, a “verifiable” CRO serving the nutra industry for more than 17 years.   He wrote an informative article titled, Understanding Clinical Trials that is excerpted below, wherein he speaks to the Project Management component in conducting a clinical trial.

Management of multiple activities, team members and providers requires the skills of an experienced project manager. The study needs to be insured from risks of adverse events that may occur directly due to the investigational product or otherwise. Registration of the study on one of the registries like clinicaltrials.gov brings transparency and credibility in clinical research on supplements. Local and central labs are interviewed and contracted. A trial supplies management agency may be hired in the absence of in-house pharmacist to ensure the integrity of the supplement during the study. A statistical plan is usually part of the final protocol, but a data management plan is developed and database validated using the chosen software. Monitoring and audit plans are drawn. Clinical research coordinators support the investigators at the site. Clinical monitors ensure good clinical practice (GCP), protocol and SOP compliance. Biostatisticians, clinical data managers, lab technicians, et al., support the project manager. It is the project managers at CROs that ensure complex and unpredictable studies conclude on time, on budget and deliver the objectives. An investigators’ meeting is recommended for studies when they use more than three sites, several labs or other complexities. It helps to bring all players on the same page prior to study. Otherwise site initiation visits are opportunities for site training, query resolution and motivation. The time taken for these important pre-study activities is typically three months.

Applied Clinical Trials recently asked the question,  What then are the 3 most important interpersonal characteristics (soft skills) of a successful project leader to ensure that all contributors to the clinical trial production chain work properly on time, within expected scope, and on budget?

The response was  “Effective communication appeared to be the key, (number 1) soft skill of a successful/ideal project leader far ahead of clear goals (2) and a proactive working style (3rd).  This conclusion mirrored the personal perception of the 226 clinical research professionals representing predominantly CRO and pharmaceutical companies who work as project managers/clinical trial managers or are interested in this role.  Interestingly, long-term experience in clinical research and overall knowledge of drug development appear, however, to be less important for a project leader as compared to other knowledge, behavior, and skills”.