TransCelerate BioPharma

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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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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QuintilesIMS to buy DrugDev

Monday, June 26, 2017

QuintilesIMS has reportedly reached an agreement to buy DrugDev, a technology company that has built one of the industry’s largest global investigator networks and data sharing platforms, the latest in series of significant mergers among CROs during recent months.   

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All for one and one for all: A call for a Three Musketeers approach to online profiles

Monday, May 22, 2017

The Pulse on Technology by Elisa Cascade

We all know there is an issue surrounding investigator participation in industry-sponsored clinical trials. Tufts University puts the figure for doctors declining to return for a second study at approximately 40%. At the same time, the number of global clinical trials continues to rise and increase in complexity. We’ve all read articles and attended conferences that expound the passionate view that investigators who commit their time and expertise need our help and encouragement. But if that’s the case, why do we as an industry fail to address the administrative burdens driving them away?

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Three Questions: Norman Goldfarb, MAGI

Monday, May 15, 2017

CWWeekly presents this biweekly feature as a spotlight on issues that executives in clinical research face. This week, writer Suz Redfearn spoke with Norman Goldfarb, chairman of Model Agreements & Guidelines International (MAGI), an organization that has spent a decade promoting the standardization of clinical trial agreements (CTAs) and contract templates that both sites and CROs or sponsors can use to speed study startup. Goldfarb is also editor of The Journal of Clinical Research Best Practices, and managing director of First Clinical Research. In April, the Association of Clinical Research Professionals gave Goldfarb their award for innovation for the MAGI CTA initiative.

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Streamlining clinical research templates to make trials faster, less expensive, more efficient

Monday, May 15, 2017

Since 2012, the nonprofit organization TransCelerate Biopharma has worked to develop a template protocol designed to cut costs and shorten timelines for industry-sponsored trials. Separately, the FDA and NIH have also spearheaded an effort to provide a template for all government-funded trials. Several years ago, the two groups began working together, and have now announced that their respective templates have been aligned to further streamline product development in the clinical research industry as a whole.

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