News

FDA officials agree that large comparative clinical trials defeat the purpose of the abbreviated development program for biosimilars. Clinical testing is expected to gain market approval for most biosimilars, while emphasizing significant differences in developing biosimilars and innovator therapies.

The pharma and aerospace industries share similarities whereas both are highly regulated, risk adverse and fast-paced markets. However, if there’s one thing that pharma companies can learn from the aerospace industry, it’s their approach to operations.

CluePoints, a provider of RBM and CSM solutions for clinical trials, announced a new Data Quality Oversight service, RADAR.

KMR Group recently conducted its annual Clinical Trial Cycle Time Report.

Worldwide Clinical Trials has received findings from a recent global survey that evaluated preferences of investigators who participated in CNS studies that employ rater training and surveillance methodologies.

ICON plc announces that it has chosen TriNetX as its platform for accessing Electronic Medical Record (EMR) systems.

The new Research Activity League Table from the NIHR Clinical Research Network shows all NHS trusts or hospital groups in England are delivering clinical research and over 60% increased their research activity last year.

Q2 Solutions, a global clinical trials laboratory services organization, has come to an agreement with Illumina, a global genomics provider.

The FDA’s launch of patient centric initiatives has led the industry to gear towards incorporating the patient’s voice in medical product development. Tom Krohn of Antidote discusses his company’s patient centered approach towards clinical trial matching by focusing on the patient.

SCRS has announced the release of the Common Language Evaluation and Reconciliation (CLEAR) contract clauses for clinical research site contracts in North America.

4G Clinical has announced the launch of its new Randomization and Trial Supply Management (RTSM) system, Prancer.

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.