WEBINAR

Beginning with the End in Mind: Inspection Readiness — A Sponsor’s Perspective

A Free CenterWatch Webinar  |  Sponsored by Just in Time GCP

Do you understand your study’s story? With increased staff turnover and an abundance of industry mergers and acquisitions, you may be at a loss.

Close those gaps with this free webinar.

When it comes time to prepare for an inspection, you either may not be aware of many of the events that occurred during the study or you may realize that with the departure of key study team members … key study knowledge and documentation are also gone.

In fact, you may not have run the study at all!

But understanding the story is essential to ensure you’re inspection ready.

Donna Dorozinsky, Just in Time GCP’s president and CEO, will explain what you need to do in these common scenarios to close the gaps. All so you can positively impact the story’s outcome and be truly inspection ready.

She’ll share a strategy for identifying key parts of your story that represent your study’s unique inspection risks, what you can do now to become more inspection prepared and the key processes you can put into place at study start-up so you’re continually inspection-prepared.

Even if you didn’t participate in the study, she will help you understand its story.

Webinar Takeaways:

• How to identify key study activities where inspection risk may exist and get recommendations for how to understand the story of your study and ensure it aligns with what you said you were going to do and what the documentation shows that you did
• An approach that will allow you to understand your study’s story even if you acquired it through a merger or acquisition and were not a participant in the management of the study
• Identify key processes to put in place at study start-up to ensure that inspection preparation is integral to routine business rather than a later issue of crisis management
• Ideas for better inspection preparation, e.g., where to look for information that may or not be in the TMF and how to put the story together when content is sitting in emails, trackers and meeting minutes

You can’t remediate issues or implement process improvements if you don’t know where your story gaps are. This webinar will help you find them — and be inspection ready — before the inspector comes. Join us by registering today.

Who Will Benefit:

• Clinical operations staff
• Study managers
• Clinical trial assistants (CTAs)
• VP
• Statisticians
• Clinical supply staff
• Regulatory affairs personnel

Meet Your Presenter:

Donna Dorozinsky
President & CEO
Just in Time GCP

As the President and CEO of Just in Time GCP, Donna Dorozinsky is responsible for running all facets of the business. She is a registered nurse and business consultant who has spent over 30 years in drug development with extensive experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management and TMF management. Her vast experiences dealing with small to large pharma and biotech companies, academic centers, regulatory agencies, CROs and investigator sites provide her with the knowledge to assist research organizations in all areas of clinical compliance. She is a member of the TMF Reference Model Steering Committee, a member of Association of Women Entrepreneurs and honored to be a founding member of Society of Nurse Scientists, Innovators Entrepreneurs, & Leaders.