Why Should You Attend:
Without this knowledge, pharmaceutical and medical device staff run the risk of cutting corners in the wrong places, thereby jeopardizing the quality of study results and leaving the organization open to potential audit findings in the future. For example, reducing the durations of activities key to assessing patient safety or efficacy endpoints, could be disastrous in the long run, and could, in fact, required additional monies for extensive re-work (e.g., additional monitoring visits, protocol amendments, extra analyses, database unlock, etc.)
Most pharmaceutical and medical device companies are concerned about completing their clinical trials as quickly as possible while staying as close to the original budget as possible, limiting unanticipated out-of-scope costs. However, depending on the complexity of the study design, thoroughness of the original protocol upon which the budget and timeline were based, and many other factors (which will be highlighted in this webinar), the operational challenges of completing the study on time and within budget can be daunting. This webinar will teach attendees how to anticipate, plan for, and closely monitor key events and activities that commonly lead to delays and cost over-runs in clinical trials. Attendees will be shown how to identify areas in which teams can reasonably shorten durations without impacting data quality – and what steps must be taken by investigational sites, monitors, and internal staff to complete the same work in less time. We will also talk about events and activities that are so critical to data quality and integrity that teams in collaboration with upper management must do a very thorough risk assessment before considering shortening the timeline in these areas.
After attending this webinar, attendees will be equipped with the basic knowledge to present solid, time-tested recommendations intended to increase trial efficiency and reduce budget ‘scope creep’ to their study teams. They will also leave this webinar knowing which activities simply cannot be rushed without jeopardizing data quality or integrity and which are critical to submission success and audit readiness.
Areas Covered in the Webinar:
Common obstacles to timely study completion and budget ‘scope creep’
Impact of protocol amendments on timeline and budget
How much can you anticipate and plan for in the initial timeline and budget?
Which activities are appropriate targets for streamlining and who/what are impacted if you try to shorten durations here?
Which activities are NOT appropriate to streamline?
How to push back if your management tries to streamline activities that you know require the duration stated in the timeline?
When, where, and how to add buffer to your timeline?
What to do when there are unanticipated ‘surprises’? And there are always ‘surprises’!
Without this knowledge, pharmaceutical and medical device staff run the risk of cutting corners in the wrong places, thereby jeopardizing the quality of study results and leaving the organization open to potential audit findings in the future. For example, reducing the durations of activities key to assessing patient safety or efficacy endpoints, could be disastrous in the long run, and could, in fact, required additional monies for extensive re-work (e.g., additional monitoring visits, protocol amendments, extra analyses, database unlock, etc.)
Most pharmaceutical and medical device companies are concerned about completing their clinical trials as quickly as possible while staying as close to the original budget as possible, limiting unanticipated out-of-scope costs. However, depending on the complexity of the study design, thoroughness of the original protocol upon which the budget and timeline were based, and many other factors (which will be highlighted in this webinar), the operational challenges of completing the study on time and within budget can be daunting. This webinar will teach attendees how to anticipate, plan for, and closely monitor key events and activities that commonly lead to delays and cost over-runs in clinical trials. Attendees will be shown how to identify areas in which teams can reasonably shorten durations without impacting data quality – and what steps must be taken by investigational sites, monitors, and internal staff to complete the same work in less time. We will also talk about events and activities that are so critical to data quality and integrity that teams in collaboration with upper management must do a very thorough risk assessment before considering shortening the timeline in these areas.
After attending this webinar, attendees will be equipped with the basic knowledge to present solid, time-tested recommendations intended to increase trial efficiency and reduce budget ‘scope creep’ to their study teams. They will also leave this webinar knowing which activities simply cannot be rushed without jeopardizing data quality or integrity and which are critical to submission success and audit readiness.
Areas Covered in the Webinar:
Common obstacles to timely study completion and budget ‘scope creep’
Impact of protocol amendments on timeline and budget
How much can you anticipate and plan for in the initial timeline and budget?
Which activities are appropriate targets for streamlining and who/what are impacted if you try to shorten durations here?
Which activities are NOT appropriate to streamline?
How to push back if your management tries to streamline activities that you know require the duration stated in the timeline?
When, where, and how to add buffer to your timeline?
What to do when there are unanticipated ‘surprises’? And there are always ‘surprises’!
