Sentences with phrase «lead clinical data»

Designated as Lead Clinical Data Coordinator on a South American study.

Acted as a Lead Clinical Data Manager for one or more projects, provided support to the Lead Clinical Data Manager.

Not exact matches

The US Food and Drug Administration (FDA) partnered with Flatiron in 2016 because it is hopeful that one day this channel of real - world data can lead to breakthroughs in treatment that clinical trials may not accomplish alone.

«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.

These risks and uncertainties include, among others: the unfavorable outcome of litigation, including so - called «Paragraph IV» litigation and other patent litigation, related to any of our products or products using our proprietary technologies, which may lead to competition from generic drug manufacturers; data from clinical trials may be interpreted by the FDA in different ways than we interpret it; the FDA may not agree with our regulatory approval strategies or components of our filings for our products, including our clinical trial designs, conduct and methodologies and, for ALKS 5461, evidence of efficacy and adequacy of bridging to buprenorphine; clinical development activities may not be completed on time or at all; the results of our clinical development activities may not be positive, or predictive of real - world results or of results in subsequent clinical trials; regulatory submissions may not occur or be submitted in a timely manner; the company and its licensees may not be able to continue to successfully commercialize their products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to governmental payers; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading «Risk Factors» in the company's most recent Annual Report on Form 10 - K and in subsequent filings made by the company with the U.S. Securities and Exchange Commission («SEC»), which are available on the SEC's website at www.sec.gov.

Mary Edwards, who leads Accenture's work with federal civilian health agencies, explained to MobiHealthNews during an interview that this type of data increasingly is collected by consumer devices, like Fitbits, and is rarely a part of a clinical or claims record.

Inadequate case selection and intrapartum management, as well as grouping together maternity units with markedly different skill levels, lead to misinterpretation of the data and premature clinical changes.

Owlet, a leading manufacturer based in Utah, emailed a defense of its $ 250 «smart sock» monitor: «We have invested millions of dollars into data collection, as well as the creation of a clinical team... to further knowledge of the issues affecting infant health.

Previous results from the trial have already changed clinical practice — data released last year has led to docetaxel chemotherapy now being part of the standard of care for many men with prostate cancer.

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.

Several years ago, for example, poor chemical probe data led researchers to pursue a final stage clinical trial on a cancer drug candidate called iniparib.

Led by Sudha Ram, a UA professor of management information systems and computer science, and Dr. Yolande Pengetnze, a physician scientist at the Parkland Center for Clinical Innovation in Dallas, the researchers looked specifically at the chronic condition of asthma and how asthma - related tweets, analyzed alongside other data, can help predict asthma - related emergency room visits.

The research, led by Knut Wittkowski, biostatistician in the Center for Clinical and Translational Science at The Rockefeller University Hospital, is a twist on a traditional data - mining technique known as a genome - wide association study.

Mathias Uhlen, director of the Human Protein Atlas project and co-author of the paper, says: «I am extremely pleased that the resource created through the Human Protein Atlas effort has been used in the analysis of clinical data obtained from liver disease patients and that this analysis has led to the identification of liver - specific drug targets that can be used for treatment of this clinically important patient group.»

The research team, led by Benjamin Abella, MD, MPhil, clinical research director of the Center for Resuscitation Science, examined data on 7,137 cardiac arrest cases across 47 counties in 2012 and 2013 from Pennsylvania's Cardiac Arrest Registry to Enhance Survival (CARES).

They have the opportunity to be exposed to a wide variety of clinical and patient - oriented research, from Phase I, II, and III trials to collection of samples and clinical data used to identify genetic variation that leads to human disease.

► «Data from studies of Zika virus and its clinical effects should be shared as soon as possible, without scientists having to worry that they're endangering a later publication, dozens of leading journals and research funding agencies said Wednesday in a statement,» Vogel wrote in a ScienceInsider published that day.

Data from studies of Zika virus and its clinical effects should be shared as soon as possible, without scientists having to worry that they're endangering a later publication, dozens of leading journals and research funding agencies said today in a statement.

«There is very little data on the time cost of healthy eating,» said Pablo Monsivais, Ph.D., M.P.H., the study's lead author and a senior university lecturer with the Center for Diet and Activity Research at the University of Cambridge School of Clinical Medicine in England.

«Our data provide a link between impulsivity and compulsivity,» says lead author Jeffrey Dalley, an experimental psychologist at Cambridge's Behavioral and Clinical Neuroscience Institute.

The research team, led by Eduardo Vilar - Sanchez, M.D., Ph.D, assistant professor, Clinical Cancer Prevention, reviewed data from 193 patients diagnosed with CRC in this age rage that were evaluated by genetic counseling at MD Anderson between 2009 and 2013.

While the last decade has seen many potential new agents for hepatocellular carcinoma fail in clinical trials, phase I and II data from early regorafenib trials were promising, and led to the initiation of this international, multi-center phase III trial.

The current study combines data from five clinical trials involving a total of 1,287 people, including the SWIFT PRIME trial led by Saver, that show these devices improved outcomes for people with acute ischemic strokes due to large vessel blockage.

«The CDC is being appropriately cautious and doing the right thing based on available data,» said lead author Kenneth J. Smith, M.D., M.S., professor of medicine and clinical and translational science in Pitt's School of Medicine.

She also leads the Data Management and Statistics Core for the BU Alzheimer's Disease Center and directs data management efforts for the BU Clinical and Translational Sciences InstitData Management and Statistics Core for the BU Alzheimer's Disease Center and directs data management efforts for the BU Clinical and Translational Sciences Institdata management efforts for the BU Clinical and Translational Sciences Institute.

Community Practice Connections ™: 21st Annual International Congress on Hematologic Malignancies ®: Focus on Leukemias, Lymphomas and Myeloma consists of a series of interactive clinical vignettes, short video interviews with leading experts in hematologic malignancies, and short summaries of clinical data related to these issues.

This will allow patients to be more quickly matched to potentially lifesaving clinical trials, even as it leads to larger and richer analyses of data for research purposes.

LA JOLLA — The Salk Institute, which hosts a National Cancer Institute (NCI)-- designated cancer center and Indivumed GmbH, a world leading cancer research company today announce a multi-year strategic alliance to secure, preserve and analyze human cancer tissue and annotated clinical data from consenting patients around the world, enabling the most cutting - edge basic and translational research in cancer.

Together with the research and clinical resources of the nation's leading cancer hospital, we have the ability to take a program from a research hypothesis all the way to a clinical candidate supported by robust preclinical data, and into early phase clinical studies in well - defined patient populations.

TCGA and TARGET taught the research community the importance of combining patients» medical data with cancer genomics data, leading to NCI programs that integrate rich genomic and clinical datasets.

Our Africa - based staff play leading roles in preparing for and implementing clinical trials, ensuring the needed laboratory capacity, and overseeing trial data management.

Dr. Jain proposed the design for the adaptive clinical trial platform and will lead the center's quantitative effort on design development and the analysis of the various types of data that will be generated in these multi-year adaptive trials.

It is led by EMBL - EBI with the purpose of creating a secure, on - demand e-infrastructure for clinical metabolomics data.

The report stresses that the UK is home to world - leading data sources in the form of Clinical Practice Research Datalink (CPRD), UK Biobank, and Genomics England.

The CGGH is leading this area of analysis by integrating the clinical data with genome sequencing data on 1,000 parasite samples collected by the study.

The MRC Centre for Genomics and Global Health (CGGH) is supporting TRAC by leading a genome - wide association study and population genetic analysis that integrates TRAC clinical data with genome sequencing data generated through a partnership with MalariaGEN and the Wellcome Trust Sanger Institute.

Genome sequencing of the TRAC clinical samples has now been completed, generating terabytes of data that were processed by the sequence - analysis pipeline team led by Jim Stalker, to produce quality - controlled information about many thousands of variants for each sample.

In his role as IDRI's Chief Medical Officer, Corey is developing and leading all clinical trial programs for IDRI from preclinical to Phase III, including oversight and management of data functions.

He has also been leading statistical data analysis for the Broad Institute's Proteome Characterization Center and Proteogenomic Data Analysis Center established under the National Cancer Institute Clinical Proteomics Tumor Analysis Consortium (CPTAC), focusing on proteogenomic analysis of proteomic, phosphoproteomic, and genomic data derived from cancer sampdata analysis for the Broad Institute's Proteome Characterization Center and Proteogenomic Data Analysis Center established under the National Cancer Institute Clinical Proteomics Tumor Analysis Consortium (CPTAC), focusing on proteogenomic analysis of proteomic, phosphoproteomic, and genomic data derived from cancer sampData Analysis Center established under the National Cancer Institute Clinical Proteomics Tumor Analysis Consortium (CPTAC), focusing on proteogenomic analysis of proteomic, phosphoproteomic, and genomic data derived from cancer sampdata derived from cancer samples.

Data from patients with familial AD with autosomal dominant mutations4 and longitudinal observation of individuals with positive Aβ PET scans and normal cognition led to the observations that amyloid plaque pathology could be present as long as 2 decades prior to the emergence of the first clinical symptoms of AD.

Clinical Studies: Our clinical core, led by Dr. Kurt Christensen, conducts economic analyses alongside prospective clinical studies to better understand the full costs of sequencing and to collect real - world data about health care utilization and clinical outcomes following genomiClinical Studies: Our clinical core, led by Dr. Kurt Christensen, conducts economic analyses alongside prospective clinical studies to better understand the full costs of sequencing and to collect real - world data about health care utilization and clinical outcomes following genomiclinical core, led by Dr. Kurt Christensen, conducts economic analyses alongside prospective clinical studies to better understand the full costs of sequencing and to collect real - world data about health care utilization and clinical outcomes following genomiclinical studies to better understand the full costs of sequencing and to collect real - world data about health care utilization and clinical outcomes following genomiclinical outcomes following genomic tests.

Dr. Ghouri previously founded Anvita Health which analyzed more than two billion data points per day (millions of patients per hour) to deliver clinical insights to leading insurers, national labs, PBMs, the largest claims clearinghouse, university hospitals, and the leading search engine.

«This study allowed us to evaluate the protective efficacy of several prime - boost vaccine combinations, and these data will help guide the advancement of the most promising candidates into clinical trials,» noted lead author Dr. Dan Barouch of Beth Israel Deaconess Medical Center at Harvard Medical School and the Ragon Institute of MGH, MIT, and Harvard.

Animal Cancer Foundation has assembled a scientific advisory council composed of leading experts in cancer genetics, drug development and comparative oncology to author a request for proposals for genomics laboratories capable of generating, analyzing and hosting the resulting data in the public domain allowing researchers across disciplines access to refine clinical trials improving efficiency of drug development for all.

By engaging with our industry experts, clinical data management job seekers gain instant access to a network of leading employers who rely on Hays to keep them informed of the candidates most suitable to their jobs and will also receive excellent career advice to ensure you meet your career ambitions.

Daily demonstrate the ability to provide detailed examination of data, medical documents, claim history from beginning to end as a basis for leading clinical round table discussion.

Clinical Operations lead on collaborative cross - functional projects with IT Development, business analysts and project managers to design a data reporting dashboard and practitioner scorecard to improve tracking key performance metrics

Served as lead validator in clinical team environment: created and maintained validation notebook, participated in quality assurance (QA) charts and data review, interacted with team members and company clients, validated tracking forms and collected documentation from all support programmers.

Successfully served as Data Management Project Lead within a team setting, managing all DM activities for Phase I, II, III & IV clinical trials

Projects led cover CRM, ERP including new environments, Oracle R12 upgrade; Compensation and Data Purge and Archive, Web Based Quoting, Labor Management, Automated Picking Systems and Clinical Automation.