Remo CRO

News

Tenax Therapeutics Announces Plan to Develop Levosimendan for a Pulmonary Hypertension Indication with No FDA Approved Therapies

01.24 2018.

January 16, 2018 — Tenax Therapeutics, Inc. (NASDAQ: TENX) today announced plans to advance the development of levosimendan for the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF)…. Details

Silos Can Hinder Effective HIPAA Compliance Programs

01.23 2018.

It’s never been more important—and challenging—to understand and navigate the myriad privacy regulations changing the clinical trial landscape. The Health Insurance Portability and Accountability Act (HIPAA) is complex enough on its own, says Marti Arvin, vice president for audit strategy with CynergisTek, Inc., “but don’t forget Common Rule provisions around protecting the individual, which includes […] Details

Navigating Device Study Design Presents Unique Challenges

01.23 2018.

Unlike drug studies, medical device studies have very different timelines and need to have short-term data for the product to go to market effectively, says Victor Chen, director of clinical affairs for Align Technology, principal with the CK Clinical Group, and a member of the Clinical Researcher Editorial Advisory Board. Marketing wants to see “claims […] Details

Are Underqualified Monitors Damaging Your Clinical Trials?

01.20 2018.

Sponsors too often make the mistake of accepting one or two years of tenure from potential monitors as an adequate credential, without properly examining tangible skillsets, says Jill Matzat, BSN, RN, CCRT, CCRA, president of Medical Research Management, Inc. In those cases, sponsors “really don’t know what they’re getting,” she notes. “You’re actually better off […] Details

FDA Launches Initiative to Promote Clinical Trial Transparency

01.19 2018.

In an effort to boost scientific progress, new drug innovation, and clinical trial transparency, the U.S. Food and Drug Administration (FDA) will publish certain information from sponsor-produced clinical study reports (CSRs), beginning with documents volunteered by manufacturers following a drug’s approval, Conmmissioner Scott Gottlieb, MD, announced earlier this week. The agency will select up to […] Details

Popular morning sickness drug 'ineffective,' study reveals

01.19 2018.

When diet and non-medical treatments fail, a drug to treat morning sickness may be the answer. But new research calls its effectiveness into question. Details