TransCelerate BioPharma

Tracking adoption of risk assessment and RBM

Sunday, October 1, 2017

For all the talk about how risk-based monitoring (RBM) can improve efficiencies in clinical trial processes, the actual level of execution varies widely among sponsor companies, the industry lacks a uniform approach to the methodology and some organizations have not yet pursued alternatives to traditional monitoring strategies.

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Electronic trial applications and the next phase of site interactions

Monday, September 25, 2017

The Pulse on Technology by Elisa Cascade

The relationship between sponsors, CROs and clinical trial sites is a crucial aspect of clinical trial success. Historically, most trial communication has happened in person or via fax, but over the past 10 to 15 years, communication has largely shifted to email. Today, with the increasing popularity of electronic trial applications, sponsor, CRO and clinical trial site interactions are now beginning the next phase of process transformation with access to study resources, facilitated workflow and transparency for all parties.

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TransCelerate BioPharma adds Novartis

Monday, September 18, 2017

TransCelerate BioPharma announces the addition of Novartis to the biopharmaceutical nonprofit organization, growing the consortium to 19 biopharmaceutical companies. In addition, TransCelerate membership have elected Elliott Levy, M.D., Senior Vice President, Global Development at Amgen as the new Chair of the Board of the Directors and David Nicholson, Ph.D., Executive Vice President, and Chief R&D Officer at Allergan, will assume the Vice Chair role.

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Is eConsent adoption poised to grow?

Friday, September 1, 2017

Activity in the eConsent sector has risen considerably during the past six months, with Medidata’s acquisition of electronic informed consent pioneer Mytrus and the entry of new market players, even though widespread industry adoption of the technology has appeared to have stalled.

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Site selection a continuing conundrum

Friday, September 1, 2017

For many companies, searching for clinical trial sites begins with a look at paper-based and spreadsheet tools that document where they had held earlier trials. Returning to familiar sites allows clinical trial teams to work with principal investigators with whom they have built relationships over time.

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Evidence-based site selection and study planning

Monday, August 14, 2017

The Pulse on Technology by Elisa Cascade

Any sponsor, CRO or third-party involved in site selection and study planning will tell you that data driven tools are the key to success. Thankfully, sponsors have a range of tools to choose from in today’s market that offer tables, charts, graphs, heatmaps, projections, scoring and in-depth reporting. The most important difference between these tools, however, is not the user interface, but rather the underlying data sources. So for sponsors, the question remains, “Are the tools responsible for successful study planning and site selection? Or should we worry about the data that feeds them instead?”

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Vive le Mobile Revolution! But are clinical trial sites ready?

Wednesday, July 5, 2017

The Pulse on Technology by Elisa Cascade

In the past, the pharmaceutical industry has been reluctant to jettison old-fashioned methods in favor of new technologies. This has bolstered the industry’s critics, who argue that the old methods are to blame for the growing costs and timeframes of clinical development. However, this has begun to change over the past five years due to several factors, including regulatory authorities’ willingness to consider new approaches to clinical trial operations. As a result, technology is now being introduced into the industry at a rapid rate, with a high degree of trial use, but lower overall adoption1.

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