Sentences with phrase «clinical safety data»

This veterinary formulation carries years of clinical safety data, blood monitoring, and case studies.

Not exact matches

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).

We do this by conducting clinical trials in which we collect safety and efficacy data about our experimental drugs with the goal of submitting those data to regulatory authorities, like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), so that these experimental drugs can be approved for use by patients.

While patient safety, clinical informatics, data analytics, and improving quality outcomes remain top of mind among hospital - based healthcare IT leaders, cybersecurity and data privacy and security issues have risen nearly to the top of the list of concerns of those leaders.

«If nanoparticles are carrying a drug to deliver, different uptake could mean different therapeutic efficacy and other important differences, such as safety, in clinical data.»

Demonstrating the health benefits in these substances and determining the safety of the substances when consumed can be difficult because a lot of data from human clinical trials are required.

Meanwhile the two potential Ebola vaccines, currently in clinical trials, will have initial safety data in November 2014.

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.

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 researchers plan to gather the safety data needed to take the metabolite into clinical testing in humans, a process that Gould cautions could still take years.

A small number of federal researchers deemed essential by their agencies would still report to work, such as those involved in caring for patients at NIH's clinical research center, sustaining animal colonies in research laboratories, or handling weather data seen vital to public safety.

Valid data on safety and clinical benefit of OAC resumption are missing and remain to be established, according to background information in the article.

A total of 347 patients (155 treated with vitamin E, 192 not treated with vitamin E) were included in the analysis which compared data from three clinical trials that investigated the efficacy and safety of vitamin E as a treatment for NASH: the PIVENS, TONIC and FLINT trials.

In 2011 Yale's Open Data Access (YODA) Project reached an agreement with medical device maker Medtronic to act as an intermediary for releasing all data on clinical trials of a controversial bone - growth protein whose safety had been questioData Access (YODA) Project reached an agreement with medical device maker Medtronic to act as an intermediary for releasing all data on clinical trials of a controversial bone - growth protein whose safety had been questiodata on clinical trials of a controversial bone - growth protein whose safety had been questioned.

Adam R. Glassman, M.S., of the Jaeb Center for Health Research, Tampa, Fla., and colleagues examined the incremental cost - effectiveness ratios (ICERs) of aflibercept, bevacizumab, and ranibizumab for the treatment of DME with an analysis of efficacy, safety, and resource utilization data at 1 - year follow - up from the Diabetic Retinopathy Clinical Research (DRCR) Network Comparative Effectiveness Trial.

Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes.

Abstract 96PD: J.R. Brahmer and other US researchers report clinical activity, safety and subpopulation response analysis of nivolumab in 129 pre-treated NSCLC patients, with data updated to September 2013.

Okyanos treatment protocols are developed based on published clinical data where patient safety has been established.

Along with our nonprofit partners, this program aims to collect, organize, and validate massive amounts of data generated by clinical trials across our global trial network sites in order to generate novel insights into biomarkers for safety and efficacy, novel treatment strategies, and personalization of treatment regimens.

Safety and clinical activity of ipilimumab in melanoma patients with brain metastases: retrospective analysis of data from a phase 2 trial.

In this presentation, we discuss data from studies conducted with academic, clinical, and industry collaborators that demonstrates the utility of the system as a more predictive, human - relevant alternative for efficacy and safety testing of new chemical entitites.

We have commenced a series of clinical trials designed to obtain safety and efficacy data on Epidiolex to provide to the FDA and other regulatory authorities around the world, which is necessary to be considered for approval as a prescription medicine.

We thank Abdi Naficy and Lee Hall of the National Institute of Allergy and Infectious Diseases for support and advice; Guindo Mariam Traore and Boubacar Kouyate for serving as Local Medical Monitors; the study monitors, Norbert Tamm and Denise McKinney; Mirjana Nesin and members of the Data Safety Monitoring Board; Mahamadou Traore, Bourama Kane, and Mamadou Dembélé for clinical assistance; Danzele Coulibaly and Moctar Traore for administrative support; the chief medical officer of the Bandiagara District Hospital Mahamadou Cisse for technical support; Nicole Eddington and Lisa Ware for technical and administrative support; Karen Ball for regulatory support; the team of the Bandiagara Malaria Project in Bandiagara for their dedication; and the community of Bandiagara, Mali.

We are examining ways to improve and support the responsible sharing of data by NHS clinical genetics / genomics services for patient benefit, patient safety and service quality

A strong message at the meeting from the clinical genetics professionals was that data sharing to support clinical genetics and genomics services is «necessary and urgent» for patient safety.

Because the long - term use of VPA in the clinical setting amassed pharmacokinetics and safety data, it is rational to test VPA in allogeneic BMT patients in combination with standard GVHD prophylaxis or treatment.

«It is exciting to be directly involved in creating an innovative clinical trial infrastructure that will yield important efficacy and safety data on novel asthma interventions,» says Dr. Jain, «I look forward to participating in this work and seeing how it directly impacts asthma patients.»

The encouraging safety data from this program and our preclinical and clinical experience in other neurodegenerative diseases support the broadening of our efforts to develop antisense drugs to treat a number of severe neurodegenerative diseases.»

How new technologies could be introduced into clinical practice and how data storage and safety can be dealt with was some of the topics of the Clinical Genetics Day, organised by Sciclinical practice and how data storage and safety can be dealt with was some of the topics of the Clinical Genetics Day, organised by SciClinical Genetics Day, organised by SciLifeLab.

To date there is little clinical data on the safety of herbs during pregnancy, but the anecdotal evidence and long history of use in many cultures seems to indicate raspberry leaf is quite safe.

There are no known side effects associated with it, however this may be due to a lack of clinical data rather than an indicator of skullcap's overall safety.

Whereas enthusiasm for fasting is increasing, clinical relevance remains low because of insufficient human data, including almost nonexistent controlled trials (21, 33 — 36), few clinical outcomes studies (37, 38), lack of correction for inflated type I error rates from multiple hypothesis tests, and limited safety data (39 — 41).

Unfortunately, very few clinical trials are performed with children; thus, there is limited data with which to assess safety and efficacy.

An analysis of self - reported data from 682 adults with bipolar disorder who were taking the proprietary nutrient formula reported significant and sustained clinical improvements over a 6 - month period.41 Serious safety concerns have been reported when the nutrient formula is taken with conventional medications, including toxic levels of certain mood stabilizers.38 Pregnant women and women who are breast - feeding should avoid use of this formula because of its potentially toxic high vitamin A content.

The approval was supported by two placebo - controlled Phase III clinical studies comparing Fanapt ™ to placebo and active control in patients with schizophrenia, as well as safety data from more than 3,000 patients.

Wrote the company charter for the Clinical Events Committee (CEC) and collection of clinical data including management of the CEC discussion of adjudication and classification of suspected safety and efficacy endpoinClinical Events Committee (CEC) and collection of clinical data including management of the CEC discussion of adjudication and classification of suspected safety and efficacy endpoinclinical data including management of the CEC discussion of adjudication and classification of suspected safety and efficacy endpoint events

Reviewed lab reports and clinical data; contacted sites and discussed laboratory results and actions necessary to ensure protocol consistency and patient safety.

Coordinated with Data Management personnel to reconcile key data fields between the Safety Database and the Clinical database; assisted in rectifying any discrepancData Management personnel to reconcile key data fields between the Safety Database and the Clinical database; assisted in rectifying any discrepancdata fields between the Safety Database and the Clinical database; assisted in rectifying any discrepancies.

Completed data entry of individual case safety reports (ICSRs) from clinical trials and post marketing sources utilizing ARGUS.

Key Accomplishments • Created and implemented a clinical investigation plan which increased efficiency by 50 % • Trained 15 research assistants in handling site initiation, closeout and interim monitoring work • Introduced 8 different clinical trial committees, including clinical events committee, data safety monitoring board and steering committee • Obtained 3 informed consents for human research subjects which were in limbo for 5 years

Tags for this Online Resume: Team Lead, MedDRA, RN, Acquired Immune Deficiency Syndrome (AIDS), oncology, Drug Safety Monitoring, Quality Assurance, Quality Control, Clinical Research Support, Data Management, Pharmacovigilance, FDA Reporting, IRB, International experience, Product Launch

Click Here to search for Clinical - Research - Data - Management - Statistics - Drug - Safety - Clinical - Study - Reports - Diabetics - Interventions - Budget - Management - Clinical - Operations - Regulatory - Submission - Documents - Protocol - Preparation - QA - QC - Clinical - Study - R in our 2.4 M jobs.

Tags for this Online Resume: Clinical Research • Data Management • Statistics • Drug Safety • Clinical Study Reports • Diabetics Interventions Budget Management • Clinical Operations • Regulatory Submission Documents • Protocol Preparation • QA / QC Clinical Study R, GCP, FDA, TPD Regulations FDA Regulations • Clinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutiClinical Research • Data Management • Statistics • Drug Safety • Clinical Study Reports • Diabetics Interventions Budget Management • Clinical Operations • Regulatory Submission Documents • Protocol Preparation • QA / QC Clinical Study R, GCP, FDA, TPD Regulations FDA Regulations • Clinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutiClinical Study Reports • Diabetics Interventions Budget Management • Clinical Operations • Regulatory Submission Documents • Protocol Preparation • QA / QC Clinical Study R, GCP, FDA, TPD Regulations FDA Regulations • Clinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutiClinical Operations • Regulatory Submission Documents • Protocol Preparation • QA / QC Clinical Study R, GCP, FDA, TPD Regulations FDA Regulations • Clinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutiClinical Study R, GCP, FDA, TPD Regulations FDA Regulations • Clinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutiClinical Trial Monitoring • Nutritional Biochemistry • Diet / Exercise • Metabolic Disorders, Research, Monitoring, Benefits, Cancer, Clinical Research, Insulin, clinical, oncology, pharmaceutiClinical Research, Insulin, clinical, oncology, pharmaceuticlinical, oncology, pharmaceutical, gcp

Tags for this Online Resume: clinical, affairs, scientific, trials, innovative, management, summary, documents, submission, regulatory, 510 (k), ISE, ISS, PK / PD, communicating, monitoring, tactical, strategic, literature, direct, vision, Lead, Director, documentation, resources, execution, consensus, effectiveness, safety, CRA, IVD, medical, device, pharmaceutical, presentation, manuscript, abstract, poster, programs, leadership, career, development, appraisals, optimize, goals, objectives, internal, external, research, investigator, stakeholders, customers, prioritize, product, support, milestones, Microsoft, Word, Excel, statistics, data, analysis, Powerpoint, publication, growth, deliverables, diagnostic, prognostic, treatment, competitive, proven, ability, capable, assess, strategy, feasibility, methodology, design, develop, produce, recommend, recommendation, therapeutic, supervision, review, performance, appraisal, application, indication, company, collaborate, expert, justification, senior, executive, assessment, experienced, marketing, pre-market, pre-IDE, protocol, communication, utility, pharmacology, service, deliver, delivery, drug, metabolism, absorption, excretion, train, training, mentor, mentoring, CRO, reimbursement, XLSTAT, Prism, relationship, contract, consult, consultant, ownership, responsibility, authority, delegate, trends, direction, in - vitro, commercialize, commercialization, approval, clearance, patient, oncology, cancer, metabolic, cardiovascular, kidney, disease, health, outcomes, safe, effective, toxicity, novel, unique, unmet, need, advisors, advisory, committee, IRB, ethical, justified, supportive, care, associate

Dayton Outpatient Center and Research (Dayton, OH) 8/2007 — 4/2008 Research Assistant Principal Investigator — Dr. Suresh Gupta; Sub Investigators — Dr. Arora, Dr. Choi Research Coordinator — Ritu Singla • Aided with the development and execution of various clinical research studies and programs, with a focus in diabetic neuropathy, rheumatoid arthritis, osteoarthritis, CRPS, and NSAID - induced gastric ulcers • Worked under specific instructions to run routine tests, experiments, and procedures, ensuring compliance with all established policies, procedures, quality control objectives, and related safety, environmental, and infection control standards • Collaborated in the compilation and verifications of research data, samples, and specimens while participating in related data entry, analysis, and interpretation utilizing various data management and analysis programs • Performed routine data verification and quality control, ensuring data integrity and compliance with prescribed study protocol • Searched related literature and information sources for relevant information pertaining to experiments and procedures • Assisted in the setup, operation, and maintenance of all research equipment and instruments • Administered various logistical, scheduling, and office management functions to provide high - quality subject service, efficient file and data organization, and effective department operations

Linking road casualty and clinical data to assess the effectiveness of mobile safety enforcement cameras: a before and after study

There's no requirement of clinical testing to determine the safety and effectiveness of 510 (k) submissions, though the FDA does ask for clinical data in about 10 percent of cases.