Sentences with phrase «of clinical trial processes»

The ideal candidate should highlight in their resume thorough knowledge of clinical trial processes and medical terminology, and general business skills, such as communication, time management, and computer competencies.

In addition, I think we're going to see — or begin to see — a radical rethinking of the clinical trials process.

The Pediatric Clinical Trials Office at Floating Hospital for Children is made up of a team of researchers who work directly with physicians, parents and children through every step of the clinical trials process.

Experienced in mentoring junior CRAs and project team members, training large or small groups in various areas of the clinical trial process, creating executive and operational reports, managing project timelines, and monitoring clinical sites sho...

Not exact matches

Khoshbin says the company is in the process of applying for a device exemption, which will allow it to begin clinical trials in 2015 for its flagship product, Revanesse Ultra.

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.

He is committed to leveraging the advantages of digital technology and harmonised operational, ethics and governance processes across a group of Australian cancer clinical trial sites so that patients can be linked with potentially life changing treatment trials.

Investors, however, are focused on quarterly results and often have little patience with clinical trial setbacks and the years - long process of developing drugs.

The clinical trial of Vascepa for approval in China is in process.

In fact, one of Marathon's clinical trials that the FDA used as part of its decision - making process was conducted more than 20 years ago, saving the firm plenty of study costs.

«Many investors expected a more lengthy FDA review process of the JCAR015 trial (and potentially other CAR - T programs) and feared that a higher - degree regulatory scrutiny could increase the development risk of CAR T cell,» Leerink Research said in a note co-authored by analysts Michael Schmidt, Ph.D., Jonathan Chang, Ph.D., and Varun Kumar, Ph.D. «While it may take several weeks to reopen all clinical sites of the ROCKET trial, we believe the trial shouldn't be delayed by more than ~ 3 months.»

We searched the following databases to 18 February 2016: the Cochrane Central Register of Controlled Trials (CENTRAL)(the Cochrane Library), MEDLINE including In - Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing tTrials (CENTRAL)(the Cochrane Library), MEDLINE including In - Process & Other Non-Indexed Citations (OVID), Embase (OVID), PsycINFO (OVID), and CINAHL (EBSCO); the metaRegister of Controlled Trials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing tTrials (mRCT), ClinicalTrials.gov (clinicaltrials.gov), and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing tTrials Registry Platform (WHO ICTRP)(apps.who.int / trialsearch /) for ongoing trialstrials.

He serves on the House Energy and Commerce Committee's Health Subcommittee, and last year he authored a section of important health legislation that speeds the process for new drugs to be approved through clinical trials.

Scientists are seeking the Food and Drug Administration's blessing for an unprecedented clinical trial — the first test of a drug to specifically target the process of human aging.

«It's clear that the policy has gone way out in front of the science in terms of allowing access to products that haven't been through the standard clinical trials process,» says Mark Ware, a pain specialist at McGill University in Montreal, Canada.

Figure 1 depicts a traditional paper - based data acquisition process for clinical trials, and Figure 2 is the flow chart for the proof - of - concept project.

This proof - of - concept project will be conducted in parallel with traditional processes for an ongoing clinical trial.

Catalysis Inc. consults in the areas of strategy, process analysis, and redesign, particularly associated with «electronic clinical trials»; project management infrastructure and training; implementation of enabling technologies; and clinical trial metrics.

One clinical trial involves the drug CGF166, a one - time gene therapy, which, if proven successful in humans, could regenerate new hair cells within the cochlea that can signal the part of the brain that processes sound.

The researchers reprogrammed the cells to create induced pluripotent stem cells in an FDA - compliant facility at the Broad Stem Cell Research Center; the use of this facility is an important step in the process as preclinical research moves toward human clinical trials.

HemoBioTech is in the process of obtaining permission from the Food and Drug Administration (FDA) to conduct clinical trials in the U.S..

Researchers only discovered this process in the late 1990s, but they've already begun dozens of clinical trials to gauge whether infusing patients with these small RNAs works against a range of diseases, from lung infections to liver cancer to age - related macular degeneration, a sight - stealing condition that mainly affects people over the age of 50.

So if researchers think that an individual drug for, say, chronic myeloid leukemia might work against a different kind of tumor because the two illnesses share similar biological underpinnings, they have to conduct a whole new clinical trial and go through the approval process all over again for the second condition.

Clinical trials seeking to block the process of autophagy are ongoing at the Cancer Institute.

Inglis also expects that the collaborators will «adapt and extend» the process bioRxiv now uses to screen clinical trial and epidemiology submissions: «Screening is of particular importance for medically relevant information,» he says.

Sometimes, toxic side effects aren't discovered until fairly late in the drug development process, when substantial amounts of time and money have already been invested in clinical trials.

Once a compound has shown its value in these tests, it will begin the process of drug development prior to clinical trials.

Phages would require a less traditional approach to get official approval, such as the annual process for influenza vaccines in which manufacturers secure approval of new formulas based on the flu bug that is going around that year, instead of conducting big clinical trials every time.

«Recruitment for clinical trials in children with autism is one of the biggest challenges we face in studying potential treatments, and we found that process to be accelerated and streamlined by using existing online communities for enrollment,» said lead author Stephen Bent, associate professor of medicine at UCSF.

The development process often takes 15 to 20 years or more and requires virus cultivation, animal model testing, product formulation, immunogenicity testing and years of costly clinical trials.

The downside includes cultural resistance to Good Clinical Practice (GCP), clinical research process real - time compliance, inadequate information systems leading to unpredictable project milestones, a «no clock» application process in the regulatory machinery, and inconsistent time frames for export / import of clinical trial materials at theClinical Practice (GCP), clinical research process real - time compliance, inadequate information systems leading to unpredictable project milestones, a «no clock» application process in the regulatory machinery, and inconsistent time frames for export / import of clinical trial materials at theclinical research process real - time compliance, inadequate information systems leading to unpredictable project milestones, a «no clock» application process in the regulatory machinery, and inconsistent time frames for export / import of clinical trial materials at theclinical trial materials at the border.

An initial clinical trial of simvastatin in people with early - stage MS showed reductions in brain lesions, suggesting an effect on the underlying disease process.

Streamlining the regulatory process for developing genetic and other treatments for rare diseases, recognizing the time - consuming difficulty of acquiring a critical mass of patients for clinical trials for disorders affecting very few people.

«Despite extensive preclinical approaches, translation of gene therapy strategies into clinical trials is still a difficult and expensive process.»

There is much work to be done on the product submission process including review of the physiological properties, potency and purity of substances, as well as in monograph development, standards of evidence, chemistry and manufacturing, and clinical trial development.»

UNITY has completed a rigorous screening and preclinical testing process of candidate drugs, discovered in this study, and is launching a new clinical trial to assess its first drug, for patients with osteoarthritis of the knee this year.

The gift will be distributed to the researchers in annual increments through 2021 to account for the long - term process of translating scientific insights into clinical trials and applications.

These activities are being performed in the context of several public or industry - funded R&D projects, and the in house GMP - facility has been used for process development and production of clinical trial material in different expression systems, including E.coli, Pichia pastoris and transgenic tobacco plants.

Then, clinical trials undergo a rigorous approval process both by the Food and Drug Administration (FDA) and by two separate committees of Vanderbilt physicians.

These risks and uncertainties include, among others, those relating to our ability to obtain financing and to form collaborative relationships, uncertainty regarding potential future deterioration in the market for auction rate securities which could result in additional permanent impairment charges, our ability to develop and market diagnostic products, the level of third party reimbursement for our products, risks related to preclinical and clinical development of pharmaceutical products, including the identification of compounds and the completion of clinical trials, the effect of government regulation and the regulatory approval processes, market acceptance, our ability to obtain and protect intellectual property rights for our products, dependence on collaborative relationships, the effect of competitive products, industry trends and other risks identified in deCODE's filings with the Securities and Exchange Commission, including, without limitation, the risk factors identified in our most recent Annual Report on Form 10 - K and any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10 - Q or Current Reports on Form 8 - K.

informed consent - the process of deciding whether or not to join a clinical trial, after learning enough information to make a responsible decision about participating.

The next step, Srivastava said, is clinical trials of the drugs as a therapy for asthma and COPD — a process that should be expedited since aldose reductase inhibitors have already undergone Phase III clinical trials for diabetic neuropathy.

He is also in the process of launching a clinical trial of an FDA - approved anti-epileptic drug that — as his lab discovered in 2012 — might improve brain functions in Alzheimer's disease.

Maren Monsen, Director of the Stanford Program in Bioethics in Film, will present a screening of her documentary film «Rare», which focuses on a rare genetic disorder, and discussion of the importance of patient advocacy groups and clinical trials process in the United States.

When conducting clinical trials, Rutgers Cancer Institute of New Jersey's most important responsibility is to protect patients through well - designed protocols, a dedicated Institutional Review Board (IRB), a careful informed consent process and rigorous monitoring of the safety of the clinical trial.

Research Nurse Clinicians (RNC) at Rutgers Cancer Institute of New Jersey bring specialized expertise and in - depth knowledge of the research process to patients participating in clinical trials.

Cell Therapy Catapult will develop a scalable manufacturing and differentiation process for AST - VAC2 in order to support the downstream demands of clinical trials and ultimately commercialization.

The NCTN represents «an unmatched effort to integrate and streamline the process of cancer clinical trials research,» said James Doroshow, MD, deputy director for clinical and translational research at NCI in a statement released by NCI last month.

The website is a perfect complement to the «Stem Cells in Focus» blog, housing informational pages on basic stem cell biology, the process by which science becomes medicine, clinical trials and the use of stem cells in understanding and potentially treating specific health conditions.

St. Jude has also developed exclusive manufacturing processes to produce large amounts of clinical - grade genetic material for clinical trials.