Pharmaceutical companies, CROs, and software/application vendors with operations in the European Union (EU) may be at serious risk from the new EU General Data Protection Regulation (GDPR). Violations of the regulation, which is set to go into effect in 2018, can result in penalties of €20 million or 4 percent of worldwide revenue.
TransCelerate Biopharma is all about collaboration. The group’s goal is to identify, prioritize, design, and facilitate the implementation of solutions to help sponsors efficiently and effectively produce needed medicines for patients. In this interview Deb Driscoll, VP of quality assurance at Merck and lead of the TransCelerate QMS (quality management system), discusses how the initiative hopes to improve quality in clinical trials.
Radio Free Asia (RFA) is reporting that a government investigation in China has revealed fraudulent practice on a massive scale in clinical trials. China's food and drug regulator recently carried out a one-year review of clinical trials, concluding that more than 80 percent of clinical data is "fabricated," state media reported.
Clinical News Roundup for the week of September 19, 2016 with stories on HHS and ClinicalTrials.gov, FDA approval of Exondys51, DCRI coordinating National Study of Childhood Health, and the world's largest breath-based clinical trial.
Fitness trackers were popular holiday gifts this year and sales are on the rise. While counting steps and getting fit may be the primary reason consumers are purchasing Fitbits and other wearables, other sensors these devices include, such as heart rate and sleep monitors, could actually help big pharma collect a wealth of valuable data to revolutionize personalized medicine.
In an era where data acquisition (eg. ePRO), capture (EDC) and storage (eTMF) are done electronically, it is the logical consequence to do the same for the informed consent process as all the advantages of the electronic modality equally apply to this process.
The introduction of electronic data capture (EDC) systems in clinical trial data management and analysis triggered the promise of better-managed clinical trials – with greater efficiency, faster access to higher-quality clinical data and better mapping of data flows to business processes.
The much-heralded EDC revolution has reached a decisive point, to use an equally heralded term, a ‘tipping’ point. 58% of clinical trials started last year employed EDC systems.
Comprehend today announced it has secured $21 million in Series B financing to accelerate clinical development through its cloud-based business intelligence solutions, enabling life science companies to bring new treatments and devices to market faster and more affordably. The round was led by Lightspeed Venture Partners with support from existing investor Sequoia Capital. Lightspeed partner Peter Nieh joined the company’s board of directors.
Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that it is partnering with TransCelerate BioPharma Inc. ("TransCelerate") on a project designed to inform the nonprofit organization’s continued efforts to modernize and streamline the way clinical trials are conducted and monitored worldwide.
Exco InTouch, the leading provider of patient engagement and data capture solutions for clinical research and healthcare providers, recently announced the appointment of Laurence Burke as Vice President of Operations.
BioClinica, Inc. a global provider of clinical trial management solutions, recently announced that members of its team will attend, participate in, and speak at several upcoming industry conferences in April, May, and June.
Exco InTouch, the leading provider of patient engagement, data collection and communication solutions for the pharmaceutical and healthcare sectors, recently announced that it has joined the Electronic Patient-Reported Outcome (ePRO) Consortium, a programme run by the Critical Path Institute (C-Path), which strives to enhance the quality of patient reported outcomes (PRO) in the evaluation of new pharmaceuticals.
DATATRAK International, Inc. a leader in developing cloud-based, unified eClinical® technologies and delivering related services for the clinical trials industry, today announced Chris Wilke, DATATRAK’s Chief Technology Officer, was elected as the CDISC Advisory Board’s (CAB) Chair-Elect.
DATATRAK International, Inc. (OTCQX: DATA), a leader in developing cloud-based, unified eClinical technologies and delivering related services for the clinical trials industry, today announced its participation at several industry events during the month of October.
Clinovo announces that it has successfully attained the status of CDISC Registered Solutions Provider by the Clinical Data Interchange Standards Consortium (CDISC) organization. With this milestone, Clinovo demonstrates its active participation in the pharmaceutical industry in the implementation of clinical standards.