Sentences with phrase «clinical study data»

Assisted effectively with the role which included Definition, Capture and Delivery of Clinical Study Data.

• Monitored site management and coordinated with Director of Clinical Studies to achieve satisfactory compliance with company standards and regulatory demands • Trained, monitored and coordinated incoming staff and oversaw clinical study completion • Developed clinical study plans that were in compliance with industry standards and created assigned studies issued by company R&D department • Oversaw the development and creation of clinical study materials, trained and supervised investigators and field staff of various sizes depending on individual studies • Compiled clinical study data and directed corrections as needed • Worked with Director of Clinical Studies and department managers to compile final reports and create presentations for CEO and Board of Directors

Collaborated with clinical trial teams to develop and maintain databases for clinical study data collection and analysis

Not exact matches

«We had been offering our Depression Care service for a number of years, and we wanted to dig into our data and measure our impact... look and see who our end users were,» says Barb Vader, Vice President, Clinical Services at Morneau Shepell, and the study's research lead.

Shorn of human weaknesses like the need to eat or sleep, computers are now speed - reading through not only the vast academic literature but also CT scans, electronic medical records, and mountains of data from clinical trials and genomic studies.

And Marathon barely did any actual clinical legwork to get the drug cleared for Duchenne — it relied on 1990 - era clinical trial data before tacking on just enough study material to win an approval that doesn't even address the root cause of the disease.

And the giant that makes the platform he's building on, Apple, for example, is running large - scale medical studies using its software, and is said to be looking to handle clinical data as the first step to a real attempt to break into the medical market.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

«[A.I.] can help analyze large data sets from sources such as clinical trials, health records, genetic profiles, and preclinical studies; within this data, it can recognize patterns and trends and develop hypotheses at a much faster rate than researchers alone,» says Deloitte.

Using data from clinical food challenge studies, the VSEP has identified reference doses for the common food allergens at which 95 - 99 % of the allergic population are unlikely react (1,2).

Among 11 study participants for whom data from the oral food challenge were either inconclusive or not available, a diagnostic algorithm based on clinical history, the results of a skin - prick test, and the values for peanut - specific IgE were used to determine whether or not a participant should be considered to have peanut allergy (Fig.

It's also the least - studied, so I'll report back when more clinical data becomes available.

A search of Pubmed [a data base containing all medical journal articles] for platelet rich plasma yields 6,811 articles, but less than 20 are clinical studies evaluating patient outcomes for orthopedic sports medicine conditions.

Study published in medical journal (Journal of Allergy and Clinical Immunology) provides data that shea butter does not contain allergy proteins that tree nut allergic individuals are prone to being irritated.

Individual data collection forms, designed as part of the cohort study, documented duration of labour, mode of delivery, some forms of pain relief, active management of the third stage of labour, whether an episiotomy was performed, clinical complications, length of stay for both mother and baby by type of ward and level of care, and transfers by duration and mode.

Other strengths of the underpinning cohort study include high participation by midwifery units and trusts in England; the minimisation of selection bias through achievement of a high response rate and absence of self selection bias because of non-consent; and the ability to compare groups that were similar in terms of identified clinical risk.12 The economic evaluation was conducted according to nationally agreed design and reporting guidelines.15 26 Collection of primary unit cost data was thorough and accounted for regional differences in care patterns.

These virtual results are based on the actual data points derived from StriVectin's extensive clinical studies for StriVectin - SD ™ Intensive Concentrate for Stretch Marks & Wrinkles and StriVectin - SD ™ Eye Concentrate for Wrinkles.

The initiative was introduced to the United Kingdom in 1993, but, although improvements have been reported, 3 rates of breast feeding in the UK are still among the lowest in the world.4 5 Recent reports from the National Institute for Health and Clinical Excellence (NICE) urge NHS units to become baby friendly to improve rates of breast feeding and save money.4 6 Data from the millennium cohort study, however, show that though participating maternity units in the UK increased rates of initiation of breastfeeding, duration did not increase.5 Other strategies are therefore required to support mothers in the UK to breast feed for the recommended time.

Clinical project coordinators of the unit regularly monitored sites to ensure accuracy of recruitment and data collection as well as strict compliance to the study protocol.

Semi - annual journal featuring research, theory, case studies, clinical intervention data.

Since 2006, she has co-ordinated the review process, written to authors for additional information, managed data for the review, re-extracted data from papers, re-entered data into Review Manager, re-entered data for the included studies section, analysed and interpreted data, and provided a clinical and policy perspective.

The case - control study, published online in of the Journal of the American Academy of Dermatology, used a large clinical database of electronic medical records to collect detailed data of cutaneous melanomas developing in 462 women aged 49 years or younger.

This is the first study of a life - sustaining treatment form using the Long - Term Care Minimum Data Set, or MDS, a federally mandated clinical assessment of all residents in nursing homes certified by Medicare or Medicaid.

Since in science no one study is a final answer, CTT gathers data from numerous clinical trials and feeds them into a meta - analysis — a calculation that combines data from different studies to come up with a wide - angle view.

The researchers were never able to obtain the data from the original clinical trial sponsor and in the end had to painstakingly reconstruct the study results from the information collected at each individual study site.

For this study, the researchers looked back at 11 years of clinical data.

In a clinical review published in the Feb. 10 issue of The Journal of the American Medical Association, Moffitt physicians, Sondak and L. Frank Glass, M.D., described data from an Australian melanoma screening study that supports more extensive high - risk population - based screening programs.

In an effort to find out, Stephen P. Juraschek, M.D., Ph.D., research and clinical fellow in general internal medicine at the Johns Hopkins University School of Medicine, and his colleagues used data from the DASH (Dietary Approaches to Stop Hypertension) clinical trial, a widely popular and often - cited study whose results were first published in 1997.

According to Dr. Cameron Carter, Editor of Biological Psychiatry: Cognitive Neuroscience and Neuroimaging, the study is an important example of how more sophisticated approaches to analyzing brain imaging data examining transitions between mental states over time can measure altered brain dynamics that can identify subtle risk states or even track the transition from subclinical to clinical psychopathology.

Data from the CenterWatch study indicate that over 70 % of clinical trial sponsors and service providers feel that the adoption of electronic data collection would be more rapid absent the fear of regulatory repercussiData from the CenterWatch study indicate that over 70 % of clinical trial sponsors and service providers feel that the adoption of electronic data collection would be more rapid absent the fear of regulatory repercussidata collection would be more rapid absent the fear of regulatory repercussions.

In the current study, Zhang and her colleagues, including Esther John, Ph.D., senior cancer epidemiologist at the Cancer Prevention Institute of California, analyzed data on 6,235 American and Canadian breast cancer patients from the Breast Cancer Family Registry, a National Cancer Institute - funded program that has collected clinical and questionnaire data on enrolled participants and their families since 1995.

The new review integrates animal studies, clinical trials, and public health data to help explain rising cancer rates among young adults.

«I think this is a step towards making sense out of a lot of data — genetic data, environmental data, epidemiological data — to help us understand factors that contribute to long and healthy life,» says Winifred Rossi, deputy director of the Division of Geriatrics and Clinical Gerontology at the National Institute on Aging, who wasn't involved in the study.

Researchers derived data from the Harvard Aging Brain Study, an observational study of older adult volunteers aimed at defining neurobiological and clinical changes in early Alzheimer's disStudy, an observational study of older adult volunteers aimed at defining neurobiological and clinical changes in early Alzheimer's disstudy of older adult volunteers aimed at defining neurobiological and clinical changes in early Alzheimer's disease.

The authors do note that this large study can not definitively prove cause and effect; nonetheless, the findings are strongly consistent with «a wealth of existing observational and clinical trial data to support health benefits of nut consumption on many chronic diseases.»

Still, «despite the lack of controlled data, there are some things that appear so frequently and prominently in Ebola virus disease survivors that we feel comfortable attributing them to [Ebola],» says senior study author Daniel Bausch, a physician on WHO's Clinical Care Team for Ebola.

Led by Dr Steven Marwaha, a clinical academic Psychiatrist, the research analysed data from the Avon Longitudinal Study of Parents and Children and found that teenage cannabis use at least 2 - 3 times weekly is directly associated with suffering from symptoms of hypomania in later years.

«It was clear from our findings that many people with IBS should have their vitamin D levels tested, and the data suggests that they may benefit from supplementation with vitamin D. «As a result of this exploratory study, we're now able to design and justify a larger and more definitive clinical trial.»

A team of clinical pharmacologists, statisticians and IT experts conducted a risk analysis of the problems at Cetero, she said, and they «concluded that the risk of a misleading result was very low given how the studies were done, how the data were captured and so forth.»

In a study that included children and young adults with relapsed or refractory cancer, incorporation of integrative clinical genomic sequencing data into clinical management was feasible, revealed potentially actionable findings in nearly half of the patients, and was associated with change in treatment and family genetics counseling for a small proportion of patients, according to a study in the September 1 issue of JAMA.

«But as a clinician, if there are randomized data that would allow us to go from a pilot study to a phase 3 clinical trial, and if the results are good, then we would have to come back to Francis Collins, and say, «This needs to be exported to other communities and ramped up.»

Three studies presented at the American Epilepsy Society's 69th Annual Meeting in Philadelphia highlight emerging efficacy and safety data of Epidiolex, a pharmaceutical liquid formulation of cannabidiol, which is currently undergoing U.S. Food and Drug Administration (FDA) authorized Phase 3 pivotal clinical trials in the United States and across the globe by GW Pharmaceuticals.

And data from clinical studies already get out before they're published, for instance in press releases and at medical meetings, Krumholz said; why not make the full results public?

«Our partnership with families who have a child with Down syndrome and our investment in a comprehensive clinical data and biorepository will continue to provide resources to study not only heart defects, but also other Down - syndrome associated medical conditions such as cognitive function, leukemia, and dementia,» says co-author Stephanie Sherman, PhD, professor of human genetics at Emory University School of Medicine.

Study data also indicated that the high - dose vaccine may provide clinical benefit for the prevention of hospitalizations, pneumonia, cardio - respiratory conditions, non-routine medical visits, and medication use.

Aucott will feature the joint study as an example in his 2016 AAAS Annual Meeting presentation, Big Data Clinical Realities and the Human Dimensions of Interoperable Data.

The documentation ranges across the whole spectrum of drug development: Investigators» brochures provide information on all that is currently known about the medicine and so need periodic updating; accurate and concise protocols are required to ensure that trials are performed effectively; clinical trial reports (generally from phase II and III studies) present the information gathered from the trials; higher level documents provide summaries of efficacy and safety data from clinical trial programmes; expert reports provide critical interpretation of the results; and response documents clarify any points that are not clear to the regulatory agencies or provide additional analyses or supporting data for any items of concern.

«The multidisciplinary collaboration in this study combines clinical expertise, health services knowledge, electronic health records, and non-traditional big data sources to address the major health challenge that is asthma,» she said.

«Our analysis shows that having access to firearms is a significant risk factor for men committing suicide and for women being victims of homicide,» said Andrew Anglemyer, PhD, MPH, an expert in study design and data analytics in Clinical Pharmacy and Global Health Sciences at UCSF, who is also a U.S. Army veteran.