Gain insight into the significance of meticulous contract examination when choosing an outsourcing partner.

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.

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.

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.

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.

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.

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.

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.

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.

Large CROs have a vast pool of resources and a subset of amazingly talented people. However, the decision to select such a CRO on the concept that they have access to the best talent, and the hope that those resources will be assigned to your study, is flawed.  

Most quantitative and qualitative studies seeking to understand what creates fear and anxiety in humans conclude with some version of the same 4 key criteria: Lack of Control, Large Consequence, Sudden Occurrence, and Unfamiliarity. In our outsourcing industry, it is never an easy decision to select a partner when trying to run complex sequential trials. The need to gain regulatory approval for the treatments you have dedicated yourself to providing, coupled with the need to find a capable, reliable, and fair Contract Research Organization is quite daunting.

The theory of Corporate Memory is easy to understand and agree with – the better you record and understand recurring actions the better you will perform those actions. Read why Capitalizing on corporate memory might work at an individual level but is nothing more than a myth and an empty promise in the complex changing world of drug clinical studies.

Have you ever asked yourself why you take comfort with governance agreements? They're created to "protect" you when your CRO fails - and even then, what can you realistically do? Find out the answers here.

Delve into four articles regarding dissecting the critical resources, processes, and key stakeholders essential for the successful completion of an ACT clinical trial.

Discover how biopharmaceutical sponsors in clinical trials leverage real-time data analytics and conduct comprehensive gap analyses to improve trial efficiency and overcome study challenges, such as patient recruitment and retention, risk mitigation, and evolving patient expectations.

Discover how clinical research services must wade through a bog of incomplete information, and sometimes outright misinformation, when it comes to seeking reliable partnerships.

Biopharma companies — particularly smaller or emerging organizations — often are unable to draw maximum value from CROs. This occurs for any number of reasons, several of which are covered in this e-book.