News

Medidata has the launch of its AppConnect Partner Program, which combines the company’s cloud and mHealth technology with access to digital health firms.

A new clinical trial regulation in Europe aims to bring about harmonization of European Union (EU) clinical trial multi-country applications. This paper poses a consensual review, fine-tuning, and validation of study classification while further clarifications on this law are sought out.

Technology advancement has been breaking down traditional barriers and has provided an answer to how the industry can move forward. The Partnerships in Clinical Trials Conference in Boston drove home this approach with three key themes that were present at the event.

inVentiv Health announced the launch of two global Site Advisory Groups (SAGs) at the annual Global Site Solutions Summit.

Cincinnati-based CRO Medpace has selected Montrium's eTMF Connect and RegDocs Connect solutions.

This analysis uses a large dataset to forecast the study completion time costs of specific protocol designs and execution plans.

Veeva Systems has introduced the additions of Veeva Vault EDC and eSource Solutions to the Veeva Vault Clinical Suite.

Applied Clinical Trials and SCORR Marketing recently conducted this survey to gain insight on the challenges the health science industry is facing to ensure drug products and biomarker samples are getting to the right place, at the right time, in the right way. The survey report also includes information on inventory related issues, utilization of technological solutions, challenges at different points in the delivery process, drug product tracking and predictions on future trends in clinical supply chain management.

The FDA has signed a Cooperative Research and Development Agreement (CRADA) with CluePoints for its Central Statistical Monitoring solution.

SCRS and Eli Lilly have announced a Site Engagement Partnership.

Boston and Chicago-based academic research organization Alliance Foundation Trials (AFT) has selected Wingspan’s eTMF and Site Zone life science solutions.

As biopharma companies continue to explore and experience ways in which risk-based monitoring is implemented, the process of such can be misconstrued. Peter Schiemann elaborates on some of the current issues of RBM interpretation and implementation.

The EMA has appointed Grzegorz Cessak as its vice-chair of management for the next three years.

Medidata and the Society for Clinical Research Sites (SCRS) have announced the launch of a clinical trial Site Advisory Group (SAG).

Updated employee announcements, business news and recognition in the industry today.

Globalization has increasingly become a part of the clinical trial landscape as pharma sponsors conduct trials internationally. With language barriers being among the challenges of this process, translation management is now a must during the planning phase of a global trial.

Clinical research in China has shown potential as many biopharma companies look to enter the market, though the infrastructure is lacking. Peter Schiemann, PhD conveys his perspectives on the challenges that sponsors are facing in China.