Technology Solutions

Certara launches Phoenix PK/PD modeling and simulation software Version 8.0

Tuesday, October 3, 2017

Certara, a global provider of model-informed drug development and regulatory science, announced the launch of Phoenix 8.0. Phoenix is the most advanced, intuitive, and widely-used software for pharmacokinetic (PK), pharmacodynamic (PD) and toxicokinetic (TK) modeling and simulation. Included in this Phoenix rollout are Phoenix WinNonlin 8.0, Phoenix NLME 8.0, Phoenix Validation Suite 8.0 and Phoenix in vitro-in vivo correlation (IVIVC) Toolkit 8.0.

[Read More]

EastHORN moves to Montrium’s eTMF platform

Tuesday, October 3, 2017

Montrium, an industry provider of Electronic Trial Master File solutions, announced that EastHORN Clinical Services has selected eTMF Connect to optimize its clinical programs and TMF management. EastHORN, a European CRO, will implement Montrium’s eTMF platform to increase transparency to enable greater collaboration with sponsors, improve compliance and provide greater value for its customers.

[Read More]

Cohen Veterans Bioscience to build wellness platform for brain disorders

Monday, October 2, 2017

Cohen Veterans Bioscience and Early Signal Foundation announce a partnership to advance the use of wearable and home sensors for real-time monitoring of patients with trauma-related and other brain disorders. Early Signal Foundation, a nonprofit organization focused on disruptive health solutions for rare disorders and underserved populations, will provide an affordable analytical system to record and integrate behavioral, cognitive, physiological and contextual data.

[Read More]

FDA improves access to reports of adverse drug reactions

Friday, September 29, 2017

The FDA launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information.

[Read More]

FDA selects participants for new digital health software precertification pilot program

Wednesday, September 27, 2017

The FDA announced the names of the companies selected to participate in a first-of-its kind pilot program that will help revolutionize digital health regulation in the U.S. FDA Commissioner Scott Gottlieb, M.D. announced the nine participants, who include leaders and innovators in the medical device and technology sectors, of the FDA’s digital health software precertification pilot program (FDA Pre-cert) during his keynote address at the AdvaMed MedTech Conference in San Jose, California.

[Read More]

Allianz Teams, Cyence partner on cyber risk modeling and analysis

Wednesday, September 27, 2017

Allianz Global Corporate & Specialty SE (AGCS), Allianz Group’s specialist carrier for corporate insurance business, has teamed up with Silicon Valley-based cyber risk analytics and modeling firm Cyence to boost its global cyber risk analysis capabilities. By combining Cyence’s cyber analytics platform with AGCS’ underwriting processes, the insurer will be able to analyze cyber exposures at company level for large businesses, creating a detailed understanding of their cyber risks and quickly allowing it to tailor coverage to fit specific customer profiles.

[Read More]

ERT launches eCOA platform

Monday, September 25, 2017

ERT, a global data and technology company that minimizes uncertainty and risk in clinical trials, announced a technology platform that provides fast, regulatory compliant and cost-effective clinical outcome assessment (COA) data capture during vaccine clinical development. The platform reduces the time needed to develop electronic diary cards by 75%, enabling vaccine researchers to benefit from the significant advantages electronic COA (eCOA) delivers without jeopardizing clinical development timelines.

[Read More]

CRF Health opens Romania office

Wednesday, September 20, 2017

CRF Health, a global provider of patient-centered eSource technology and service solutions for the life sciences industry, will officially open their Romania office and welcome to the helm a new VP of Global Services, Adina Tapalaga.

[Read More]