News

Cogstate Ltd., a cognitive science company, and Clinical Ink, a provider of eSource and patient engagement technologies, have announced an alliance.

Key players gathered in Brussels recently gathered to discuss how health technology assessment should be implemented going forward. While cooperation was the main theme, this approach may have proven to complicate rather than alleviate.

Market trends are driving the need for biopharma to decrease fixed costs, leading to increased outsourcing to CROs. To meet greater demand, the role and profile of Project Managers needs to continuously adapt to an ever changing clinical trial environment.

The EMA has adopted a new policy to give open access to clinical reports for new medicines for human use authorized in the EU.

Hospitals and health systems are making significant changes to their research operations in conjunction with the increasing complexities of clinical research. Adopting a centralized clinical trials office (CTO) can greatly assist in managing these changes.

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.

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.

Boston-based BBK Worldwide announced that its RSG (Ready. Set. Go.) program has improved patient recruitment and retention based on supporting data from five major global studies.

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.