News

Europe's closest thing to an Oscar's ceremony for bioscience will take place in early October.

Undertakes Novel Genomic ?Pre-profiling? Feasibility Study to Examine the Promise of Precision Medicine in Metastatic Colorectal Cancer Patients

In Part 1 of this article, I described a collaboration between Brock Heinz from Spaulding Clinical and Joe Dustin from Medidata, which resulted in a very interesting proof-of-concept.

Before the Orphan Drug Act of 1983 the FDA and lawmakers considered designation and incentives for orphan development without much consideration for competitors in the same orphan space.

With all the discussion in Europe of how to move towards personalized medicine and more flexible authorization procedures, it is the rare disease community that is, in many ways, offering guidance on the route ahead.

FDA recognizes the investment made by sponsors over the past decade to develop the expertise and infrastructure to utilize Clinical Data Interchange Standards Consortium (CDISC)[1] standards for study data. T

Almac?s Clinical Services business unit announced the addition of refrigerated reusable shippers to its portfolio of solutions for the management and global distribution of temperature controlled clinical supplies.

inVentiv Clinical Trial Recruitment Solutions (iCTRS), announced its strategic partnership with ViS Research to address the challenges of clinical trial site evaluation.

C.?The Association for the Accreditation of Human Research Protection Programs Inc. today announced that it has awarded accreditation to four additional organizations, including one more in Korea.

A conversation with Marc Buyse, founder of CluePoints on risk based monitoring in clinical trials

A conversation with Marc Buyse, founder of CluePoints on risk based monitoring in clinical trials

In August of 2013, the FDA released a report that analyzed clinical trial subject demographic subgroups for FDA approved medical products, which included factors such as race, age and gender.

A conversation with Marc Buyse, founder of CluePoints on risk based monitoring in clinical trials

An agency reshaped for the future. The European Medicines Agency (EMA) has announced details of its new organizational structure.

The Omnibus Final Rule (Final Rule) entitled "Modifications of the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act" became effective on March 26, 2013.

As clinical researchers, it?s natural for us to think of patients first and foremost as research participants (potential or current). But that?s not how patients think of themselves.

The Omnibus Final Rule (Final Rule) entitled "Modifications of the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act" became effective on March 26, 2013.

Theorem Clinical Research has announced the formation of a strategic alliance with Charles River Laboratories that will provide clients with an integrated solution from nonclinical testing and analysis through clinical development and registration.

While lack of commercial viability is the leading cause of Phase I failures for new drug candidates, efficacy issues dominate as the reason for Phase II failures, according to a new analysis from the Tufts Center for the Study of Drug Development.

Intralinks? Holdings, Inc. (NYSE: IL), a leading, global SaaS provider of inter-enterprise content management and collaboration solutions, and IRB Services? (Institutional Review Board Services), a leading, global provider of research ethics review and related services for the clinical research and behavioral science industries, striving for excellence in human research participant protection, today announced that the IRB Services team has selected Intralinks VIA? to support all of its secure beyond the firewall collaboration needs.

To fulfill the need for global biometrics solutions, CROS NT SRL today announced the acquisition of Stat?Tech Services, LLC ? a Contract Research Organization (CRO) with extensive experience in the medical devices sector.

Almac today announced they are now offering a Tumor Profiling service running Illumina?s next-generation sequencing (NGS) TruSight Tumor? panel as part of their biomarker discovery, development and delivery solutions.

Computer simulation will be able to mimic drug disposition in the lungs at different stages of tuberculosis infection

CTI Clinical Trial and Consulting Services (CTI) announces that it has opened an office in Milan, Italy. The office is opened through its newly created wholly-owned subsidiary, CTI Clinical Trial and Consulting Services Italy, S.R.L.

The process of bringing a new molecular entity or device to market has historically been long, costly and both paper and people intensive.

Externally validated program sets global standard for measuring competence of clinical monitors

The International Academy of Clinical Research (IAoCR) welcomes the news today from the Nursing and Midwifery Council that it is introducing three-yearly checks for nurses and midwifes from the end of 2015 to ensure they are fit to practice.

Theorem Clinical Research has announced the addition of Ximedica, a medical product development firm, to its roster of strategic alliances.