Clinical Guest Contributors

  1. CRO Oversight Essentials 6/30/2022

    Sponsors need to proactively identify and manage the risks involved with working with a CRO. This kind of oversight can help reduce the likelihood of negative consequences that could impact the quality of a trial.

  2. Market Tumult And The Need For Creative Funding For Life Sciences 6/29/2022

    Life sciences companies have not been immune to the upheaval in the financial markets, casting a pall over equity financing in the sector. Your company will need to be creative in raising capital. This article also covers M&A, synthetic royalty agreements, convertible debt, and covenants. Will there be a reckoning?

  3. The Opportunities For Conducting Vaccine Clinical Research In Latin America 6/28/2022

    A few decades ago, the development of global clinical research that integrates low- and middle-income countries was considered a dream. Now it is a pressing need. This article discusses the history of vaccine research in Latin America, how the region could help solve the vaccine clinical trial diversity problem in the U.S., and why the region is a desirable destination for such clinical research. 

  4. Diversity In Clinical Research Execution And Participation 6/27/2022

    In this article we compare the 2020 and 2021 result of the WCG Avoca Industry Survey, which explores industry respondents’ views on patient diversity in clinical research participation.

  5. RWD/RWE: To Replicate Or Continue To Learn In The Real World? 6/23/2022

    In addition to using real-world evidence (RWE) for clinical- and cost-effectiveness, it is also now being used for regulatory reviews of safety, efficacy, and quality. This article covers different types of decision-making using RWD/RWE across pharma companies, healthcare providers (HCPs), healthcare systems, payers and health technology assessment (HTA) agencies, regulators, and patients.

  6. Why Russia's Invasion Of Ukraine Threatens Our Life Science Ecosystem 6/22/2022

    I posit that only pluralistic democracies committed to the rule of law can support the kind of investment and innovation our industry requires to thrive, while autocracies can’t make the same claim.

  7. Decentralized Clinical Trials: Key Considerations For Sites & PIs 6/21/2022

    As we work to harness the benefits of hybrid and DCTs, sites and investigators must have processes that allow for the acceptance of DCTs and successful implementation. As these policies are under development, the vital viewpoints of sites and PIs are largely overlooked. This article shares these vital viewpoints of sites and PIs.

  8. How To Navigate Drug Repurposing And Bridging Studies 6/17/2022

    Rarely is a new drug the optimal version of that product, and drug companies often search for new uses, new users, or new dosage forms of an approved product after it hits the market in what is commonly known as “drug repurposing.” To receive FDA approval for a repurposed drug, companies must submit bridging studies that often include clinical trials. 

  9. How To Build A Strong CRO Partnership And Find Drug Development Success 6/16/2022

    Building a collaborative and highly engaged partnership with a CRO to optimize study enrollment is critical for a company’s success, particularly with so much reliance on virtual interactions. Here are some tips on how to do just that.

  10. Clinical Trial Duration Trends & The Study Closeout Gap 6/14/2022

    Clinical study durations are increasing. Contributing significantly is what we will refer to as a study closeout gap. Is your company positioned to reverse this trend and reduce time to market for your new drugs and therapies? This article explores study duration data as well as related labor challenges and macroeconomic trends.