Professional & Program Development
Our foundational materials are well-established, but we recognize that every site, every program, & every team is unique. Therefore, we work with clients to customize their event to attendees' specific needs.
We guarantee that attendees will receive the most up-to-date materials up through 1-year after the event they attended. If we update our materials with new information following any event, previous event attendees will receive a free new, updated electronic copy of the materials.
Everyone that attends one of our Companion Education Training Seminars will receive an individualized report that provides direct feedback on their pre- and post- seminar surveys with references and resources to help support their continued professional development.
Invest in your organization, program, or team by investing in the professional development of your employees. Provide them a seminar-styled training opportunity that will challenge them to expand their knowledge and improve their skills in applying source materials (e.g., CFR, GCP, Guidance Documents) to their daily work. We introduce material using real-life examples and anecdotes to facilitate a learning-rich dialogue between attendees to help assure information retention. Our goal is to enhance excitement, and engagement, of individuals in their daily work so that teams, programs, institutions and ultimately the science benefit from professionals that participate in these events.
Has your team experienced significant change? Maybe it's a new program or a team that has had several new members join? Or maybe there's new leadership that wants to connect and align with the rest of the team in a meaningful way? Or maybe you just want to reconnect with your team while strategizing opportunities for improvement. Regardless of the reason, this event is focused on bringing teams together and reviewing the requirements of clinical research laws, regulations, and Good Clinical Practice to clinical research operations. Foundation material is tailored to each team's needs to assure the greatest return on investment for the team. Our goal is to help teams connect, focusing on both their culture and operations that will make meaningful contributions to achieving their programmatic success!
Is your team feeling 100% confident in operational compliance with laws and regulations? Has your site experienced a less-than-stellar audit or inspection? Maybe there's been a concerning trend in monitoring reports that you want to address? Or maybe you're building a new, high-risk Clinical Research program and want to take a risk-based approach to developing systematic operations. This multi-day training event starts by aligning everyone on GCP and federal regulations governing clinical research, then digs deeper into topics relevant to sites working on building operations that facilitate a culture of compliance. Our goal is for attendees to have a solid understanding of requirements while enhancing their tools in building stronger, more resilient systems that foster scientific integrity efficiently.
Inspections are naturally stressful, time-consuming, and resource intensive. This can be particularly true for teams that have never experienced an inspection, have limited access to additional support during an inspection, or both. Our multi-day event focuses on the FDA compliance program and what sites can expect before, during, and after an inspection. We help attendees consider steps, operations, and processes that can be implemented within their structure to facilitate "5-day readiness." Although we understand inspections can, and do, happen for cause; we challenge everyone to evaluate their operations to eliminate the likeliness of this happening to them. Instead, our goal is to help everyone shift their mindsets to viewing inspections as a necessary price of success for their hard work in bringing a drug or device to market!
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