Fostering Inclusion and Diversity in Clinical Trials

Inaccessibility, inadequate engagement, and lack of trust—these are just some of the issues that limit inclusion and lead to a lack of diversity in clinical trials. So, why is diversity in clinical trials important? Diversity is important because there are many examples of drugs that behave differently from one population to another. Failing to understand […]

The Importance of Clinical Trial Transparency for Drug Development

Clinical trials require a unique approach to public dissemination. Because clinical trials often involve the collection of sensitive information, sharing clinical trial data should always be conducted through formal and secured media. However, because access to certain key information from these trials is in the public interest, a reasonable level of transparency is not only […]

What’s New Health Canada?

What’s New in: Updates from Health Canada New Private Label Medical Device Licence Application Form 07 April 2020 Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device 09 April 2020 Type of Update and Link Date Posted Guidance Document – Preparation of […]

To the Rescue: A New Hope for Your Development Program

Did You Know? Site Performance is notably inconsistent for studies that needed assistance. Common communications barriers between Sponsor and CRO that lead to rescue scenarios. Have a study that’s struggling? Our team offers complimentary study reviews. Site Performance is notably inconsistent for studies that needed assistance…  High Performers(i.e., enroll 70% of evaluable patients) Average Performers(i.e., […]

Mind the Gap(s): Early Identification of Issues is Key for a Successful NDA or BLA

Original Air Date: Wednesday, October 2, 2019 Time: 10 am (EST) | 7 am (PST) | 3 pm (CET) Completion of pivotal clinical trials is often viewed as the critical path item to submitting a marketing application to the FDA. Experience has shown that planning your marketing application should come long before completion of the […]

Why Do Clinical Trials Fail?

Large quantities of time, money, and intellectual capital are expended to plan and execute clinical trials. Yet, despite all of these investments, clinical trials don’t always succeed. But why? Clinical Trial Success Rates As a first step, let’s get a sense of how successful drug developers are with clinical trials by taking a look at […]