Attend this webinar to learn how to shorten the timeline for key deliverables such as case report form Design, database build, and duration between last patient out and database lock without negatively impacting data quality or putting data integrity at risk.It will cover useful tips and guidance about the activities that may be streamlined without reducing quality and budget considerations. The webinar will cover warnings about quality steps that should not be eliminated or short-changed in a rush to get done faster.
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:
Independent Consultant, Self-Employed
Barbara Randall is a PMP Certified pharmaceutical industry professional with over 20 years’ industry experience, having worked for several major pharmaceutical companies and one premier Contract Research Organization. She has expertise in Data Management, Clinical Trials, Project Management, Employee Development and Training, and Vendor Management.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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