UCLH initiates dosing in AstraZeneca’s Covid-19 antibody trial, CAS’ Covid-19 vaccine ZF2001 triggers immune response in trials, SII and Dynavax dose first subjects in Phase I/II Covid-19 vaccine trial, Novo Nordisk’s makes strides into Alzheimer’s with anti-diabetic drug, Roche’s Ocrevus set to top $7.6bn in sales by 2028 backed by new dosing approval, Hope for chronic kidney disease as KBP Biosciences’ KBP-5074 shows promise, TG Therapeutics’ umbralisib, ublituximab likely to face market hurdles but FDA approval highly expected, GlaxoSmithKline/Vir Biotechnology’s and AstraZeneca’ mAbs eyed in early COVID-19, Dicerna’s best hope for nedosiran use likely in non-responders to Alnylam’s Oxlumo in primary hyperoxaluria type 1, Investment firm GI Partners closes Clinical Ink acquisition, Investment firm GI Partners to acquire minority interest in Clinical Ink, IVI and SNU partner to trial Inovio’s Covid-19 vaccine in Korea, T1Detect screening could have lasting effects on T1D awareness and management, UNITY Biotechnology initiates dosing in diabetic macular edema drug trial, How Covid-19 has accelerated ‘digital health’ and the evolution of clinical trials, CureVac begins Phase III trial of Covid-19 vaccine candidate, Boehringer initiates trial of novel SARS-CoV-2 neutralising antibody.  iframe.style.border = '0'; The FDA says some clinical trials may have to go virtual as coronavirus travel restrictions and supply chain disruptions hit the drug industry. As a result they are now adopting, much more ambitiously, virtual trial technologies for  keeping their studies on track, running more efficiently, and offering added patient convenience. A clinical study is nothing without data, and a considerable amount of heavy lifting in the value of virtual trials is done via the ease and speed of data collection afforded by the wealth of technology on the market. Q: Have ERT’s business operations changed in light of COVID-19? Thousands of legitimate trials are … June 24, 2020 | 1:00-2:00 pm EDT . Shipping can be direct from manufacturer or pharmacy, or from the clinical trial site – the latter of significant assistance at present for trials that have been interrupted by the Covid-19 pandemic.  iframe.setAttribute('allowTransparency', 'true'); Customer Care iframe.setAttribute('src', form + params); Methods to support remote clinical trials may include: remote recruitment and screening; tele-consent In addition to our ‘At-Home’ solutions that enable investigative site personnel to capture respiratory and cardiac safety data when they visit patients’ homes, our Patient-Administered ECG Solution enables patients to easily conduct their own cardiac safety assessments from home by themselves, via a novel hand-held ECG device deployed in partnership with AliveCor (Figure 2). > 0) { A virtual clinical trial is one where patient assessment and data collection do not occur in traditional settings, such as a health centre or hospital, and are instead facilitated via remote interaction.  iframe.setAttribute('width', '100%');  iframe.style.border = '0';  var thisScript = document.scripts[document.scripts.length - 1]; However, with Covid-19 delivering a great big slap in the face to ongoing and planned studies, the future of clinical trials as virtual has rapidly become the very urgent present.  iframe.setAttribute('width', '100%');  iframe.setAttribute('height', 850); I see a post-pandemic scenario where the industry emphasizes optionality and leverages advanced technologies to better engage patients in clinical trials and optimize in-person investigative site visits for important complex trial aspects that uniquely require the capabilities of site personnel. Again, this works particularly well for patient populations that typically have a high risk of study drop-out.  iframe.setAttribute('type', 'text/html');  iframe.setAttribute('height', 850);  iframe.setAttribute('type', 'text/html');  iframe.setAttribute('frameborder', 0);  thisScript.parentElement.replaceChild(iframe, thisScript); COVID-19 and the Industry’s Leap into Virtual Clinical Trials, The COVID-19 pandemic has disrupted every aspect of the clinical trial ecosystem. } var form = 'https://content.ert.com/l/71652/2019-08-22/6w37fj?Hidden_Product_Line=wearbablesandbiomarkers'; The U.S. Food and Drug Administration today issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic. Are there concerns and challenges? params = params.replace(/[? } Yes they are, but they are the present too. LENEXA, KS — The U.S. Food and Drug Administration approved Moderna’s COVID-19 vaccine Friday, after months of data collection from clinical research sites like the Johnson County Clin-Trials. } Q: What do you believe will be the lasting impact on clinical operations/R&D? Shifting the entire company to working from home was essentially seamless. Solution Specialist params = params.replace(/[?  var thisScript = document.scripts[document.scripts.length - 1]; The COVID-19 pandemic has turned research business-as-usual upside down. Jim Corrigan is the President and CEO of ERT, Safety & Efficacy Endpoint Collection  iframe.setAttribute('type', 'text/html'); thisScript.parentElement.replaceChild(iframe, thisScript);  Trials have their own barriers to entry easier by the rise of eConsent solutions says some clinical during! Are happy with it 21 may 2020 — see all updates this opportunity to create positive and changes... 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