TransCelerate BioPharma

Multi-sponsor trial results website launches

Monday, March 13, 2017

It wasn’t that long ago that patients just wandered away after a clinical trial wrapped up, never learning the results of the trial, never knowing whether or not their participation made any difference.

[Read More]

Novo Nordisk, Servier, Otsuka, Teva among top sponsors

Wednesday, March 1, 2017

Sponsors have done a good job of maintaining, but not improving, the overall quality of their relationships with investigative sites during the past two years, according to a new CenterWatch survey, but performance gaps have widened across several of the attributes sites identify as the most important for conducting a successful study.

[Read More]

Electronic informed consent: The star bench-warmer?

Monday, February 27, 2017

The Pulse on Technology by Elisa Cascade

“If you build it, they will come.” While this was clearly the case in the baseball film “Field of Dreams,” the same does not hold true for all site-facing clinical trial technology. As the last Pulse on Technology column highlighted, several technologies are still sitting on the bench when it comes to use across all trials. This column takes a closer look at the technology with the lowest awareness and adoption: electronic informed consent (eConsent). To continue the baseball analogy, picture eConsent as a little boy sitting on the bench waiting to get into the game.

[Read More]

Use and adoption of site-facing technology

Monday, January 16, 2017

The Pulse on Technology by Elisa Cascade

EDC, RBM, SSO, etc.—These three-letter acronyms related to technology are enough to make your head spin. Everyone’s talking about the latest site-facing technology and how it could improve clinical trial operations efficiency, but I thought I would start off the new year (and the new Pulse on Technology column) by setting the record straight on current technology usage by global sites. This will also set us up for future deep-dives into individual clinical trial technologies!

[Read More]

Can clinical trials be reinvented?

Monday, May 16, 2016

The Pulse on Site Success by Christophe Berthoux

Over the last few years, I have been involved in several initiatives related to strengthening the sustainability and reducing the burden of sites around the globe. This momentum is growing through associations working on behalf of sites such as the Alliance for Clinical Research Excellence and Safety (ACRES), the Association of Clinical Research Professionals (ACRP), the Society of Clinical Research Sites (SCRS), the Collaborative Institutional Training Initiative (CITI), TransCelerate and others.

[Read More]

Facing protocol amendments head-on

Friday, April 1, 2016

The unplanned costs and delays associated with protocol amendments have prompted many sponsor companies to identify new approaches to simplify protocol designs and reduce the frequency of protocol amendments over the course of the past few years. Yet a new Tufts Center for the Study of Drug Development (CSDD) analysis found that the majority of protocols still require substantial amendments, which led to significantly longer clinical trial cycle times and higher costs.

[Read More]

CROs begin consolidating site landscape

Monday, February 1, 2016

Major trends in drug development will reshape the global investigative site landscape. Trends to look out for include patient centricity and big data to CROs assuming responsibility for site effectiveness and patient recruitment.

[Read More]

A look at the evolving role of study brokers

Friday, January 15, 2016

For many small to medium-sized investigative sites, the scramble to find clinical study opportunities continues to intensify.  Some sites have become part of informal networks that help find available studies for individual members, while others turn to middlemen or trial management firms, often called study brokers, who are available to assist investigative sites in boosting their business development and lead-generation efforts.

[Read More]