Clinical Research (Virtual) Forum - 220811

"Tips on Study Start up and Clinical Trial Conduct and Preparing for FDA Inspection" presented by Toks Onabanjo, Clinical Project Manager at Clinical Trials Investigate

The Clinical Research Forum provides value to the PMI Atlanta community by regularly discussing the various aspects of clinical trial projects with special focus on the need to anticipate, understand, and implement detailed project management activities in a proactive manner for clinical trials in the pharmaceutical industry.

Presentation

Study start-up is everything that must take place from the first point of contact with the sponsor to the moment that the study team is ready to screen and enroll subjects. Study start-up can be compared to the gestation period in pregnancy. The baby, in this case the study, must be nurtured and developed in a way that will produce a healthy, desired outcome; a successfully executed study.

Even though study start-up tasks are challenging, it is very satisfying when study start-up is done right. Making an informed choice to take on or decline a study can lead to satisfaction as well. The study team does not have to conduct every study that is offered and should have established criteria to guide them in their study selection. One approach may be to select the studies that offer the greatest benefit to the populations that they serve, have a high chance of enrolling an adequate number of subjects, and perform according to the protocol without logistical issues at that institution.

It takes a village to successfully conduct a study. If the right people are not involved, the study will not be conducted efficiently and effectively. This webinar will dig deep into the behind-the-scene details of such studies, including how a study is prepared, managed, and outreached to stakeholders on the study team.

Biography 

Toks leads the cross functional project teams in Clinical Trials Investigate (CTI); Atlanta, coordinating project deliverables for assigned projects for the last 12 years. He is responsible for ensuring the project is completed on-time and on-budget. Toks is responsible for overseeing projects for a client and ensuring all specifications are being followed. Toks interfaces between the client and the Proxima project team members on assigned projects regarding issue escalation, financial questions and management issues. Toks is responsible for the project budget and coordinates activities among the functional departments to ensure deliverables are on-time and on-budget.

When

Thursday, August 11, 2022, 6:00 PM - 7:15 PM

Where

Webinar

You will receive an email from the PMI Atlanta Chapter with the webinar link 24 hours before the event start time.

Fees

Due to coronavirus concerns, we will be hosting this event through webinar. Because of this change, member rate is now $8 and non-member rate is $10.

Meeting content, presenter, and location are subject to change. Refunds will not be made for changes in meeting content, presenters, or locations.

PDUs

Earn 1 PDU
Talent Triangle Category: Technical Management

PDUs can be claimed here.
For detailed instructions, please visit the CCRS User Guide.