VIDEOS

• Mastering The Complexities Of Gene Therapy Document Writing

  Gain the insight and strategic flexibility needed to confidently navigate the unique scientific, regulatory, and documentation challenges of gene therapy development.

• Who's In Charge? How To Ensure Effective Trial Oversight, Leadership

  Gain valuable insights into the role of sponsor-side Clinical Operations leadership, the risks of over-relying on CROs, and key strategies for fostering collaboration between sponsors and partners.

• Uncovering The Root Cause Of Clinical Trial Troubles

  Discover essential strategies to prevent clinical trials from reaching a crisis while gaining a deeper understanding of the importance of addressing systemic issues early.

• From Crisis To Confidence: Ensuring Smooth Regulatory Submissions

  Explore some of the major challenges that medical writing submission specialists face today and strategies that can consistently set the stage for success.

• Our Experience Creates Reliable Results

  Hear from inSeption Group clients as they share their experiences, recount their journeys and highlight the exceptional service and support they received.

• Feasibility Strategies For Research-Naïve Sites

  Feasibility is not just a science, there’s also an art to it, says Nick Palumbo, director, feasibility and study start-up, at Takeda. In this clip he talks about how difficult it is for research sites with limited experience to get on a sponsors’ radar.

• Does The Feasibility Process Differ For Rare Diseases?

  Mimi Ermens, senior director, clinical development operations, global feasibility and start-up support, at CSL Behring answers a question from the audience about whether there is a difference in how you should approach the feasibility process when dealing with rare diseases vs. common diseases.

• A Data Scientist's Opinion On Clinical Trial Feasibility

  How do we define success in the clinical trial feasibility process? Monica Jain, director, R&D data science, Johnson & Johnson Innovative Medicine has a data science background and chimes in with her opinion.

• What Data Needs To Be Shared?

  Nick Palumbo of Takeda explains that with feasibility in clinical trials, it has to be a “two-way street” between the sponsor and sites. He and Mimi Ermens (CSL Behring) talk about the types of questions that need to be asked and the kinds of data that needs to be shared by each stakeholder.

• How To Be More Proactive With Feasibility

  Monica Jain of J&J Innovative Medicine talks about how technologies, real-time monitoring, and performance-based metrics have helped improve the feasibility process and make it more proactive.

• How Can We Improve Clinical Trial Feasibility Processes?

  Inefficient. Time-consuming. Frustrating. Often, these are the words used to describe the feasibility and site selection process for clinical trials. In this Clinical Leader Live, experts from J&J Innovative Medicines, Takeda, and CSL Behring discuss how they’ve improved the feasibility assessment process.

• The Synergistic Role Of Drug Safety In Clinical Trial Operations

  Delve into the significance of adept interpersonal leadership within your drug safety program, shedding light on the operational and financial benefits that stem from fostering a collaborative environment.

• A Deeper Dive On Mitigating Financial Risk Before Selecting A Vendor

  In part two of this webinar series, presenters focus on avoiding potential risks, such as unexpected budget changes and unplanned change orders, that could jeopardize the success of a clinical trial.

• ICH E6(R3): Practical Steps For Implementation

  Watch this presentation to equip stakeholders with actionable strategies and a comprehensive understanding of the evolving clinical trial management landscape in the context of ICH guidelines.

• Mitigating Financial Risk Before Selecting An Outsourcing Vendor

  Gain insight from several clinical operations experts into the significance of meticulous contract examination when choosing an outsourcing partner.

• Trial Control Arms - Best Practices

  Mitchell Katz, SVP, global clinical operations, has “been there, done that,” when it comes to making decisions about trial control arms, which comparator to use, or the number of patients needed in a first-in-class drug development program. Katz shares his process and thinking here.

• Engaging Patients & Investigators To Improve Trial Performance

  Patient organizations are important sources of information for trial protocol design. Jessica Powell, VP, clinical operations at Alto Neuroscience, talks about how small and midsize companies without a large commercial organization can engage patients and trial investigators to improve trial performance.

• FDA & ex-U.S. Product Approval

  Trial protocol strategies for FDA approval must also meet the needs of global regulators, if a therapy is to be commercialized worldwide. Michael Krams, chief quantitative medicine officer at Exscientia explains how R&D leaders should think about FDA and ex-U.S. product approval.

• Biomarkers in Trial Protocol

  How should drug developers think about biomarkers in trial protocol design, particularly in neurodegenerative diseases? Jessica Powell, VP, clinical operations at Alto Neuroscience, shares her thoughts and experiences.

• The Model-Informed Drug Discovery and Development Program

  Drug developers should use a “model-informed drug discovery and development” program, which can help developers simplify the protocol design process, says Michael Krams, chief quantitative medicine officer at Exscientia.

• Phase 2 Clinical Trials: What to Include (And What To Leave Out)

  How do drug developers make decisions about what to include, and what to leave out, of a Phase 2 clinical trial? Mitchell Katz, SVP, global clinical operations at Kyowa Kirin discusses collecting competitive intelligence and forging relationships with regulators.

• Trial Protocol Design Do's And Don'ts

  Designing a clinical trial protocol that exhibits the value of a new drug is central to bringing innovative treatments to market. Listen in as experts share tips for ensuring no missteps go unnoticed.

• Patient Over Process: The inSeption Group Difference

  Everything we do is driven to challenge the status quo in the current outsourcing paradigm. inSeption is a home for clients and professionals who have been stifled by mainstream, high-volume, commoditized outsourcing models.