Sentences with phrase «on clinical trial protocols»

Not exact matches

Juno Therapeutics is seeking to change the protocol for the Phase II ROCKET clinical trial of its acute lymphoblastic leukemia candidate JCAR015, which the FDA has placed on clinical hold following the deaths of three patients, two of them last week.

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.

As was recently announced, Okyanos now offers an advanced stem cell treatment for diffuse scleroderma based on the well - established protocol implemented in the STAR Clinical Trial.

Cancer care for children is based on protocols established through clinical trials.

The authors concluded that these meta - analyses support the need for further controlled, larger trials to assess the clinical efficacy of rTMS on negative and positive symptoms of schizophrenia, while suggesting the need for exploration for alternative stimulation protocols.

The Animal and Human Imaging Shared Resource enables Cancer Center investigators to execute high throughput, quantitative and noninvasive in vivo imaging studies on animal models, apply and validate MRI, optical, CT, PET, SPECT and ultrasound methods for noninvasive detection and characterization in small animals and incorporate emerging and clinical relevant quantitative MRI and PET protocols into Phase I, II and III clinical trials in a centralized, cost effective manner.

She conducts clinical trials to expand research on the role of diet in diseases like MS and developed her plan to reverse MS into a book, The Wahls Protocol.

That would be a health claim — and a flagrant violation of Food and Drug Administration regulations forbidding health claims on products that haven't been proven with clear - cut scientific evidence, meaning research and clinical trials conducted according to strict protocols.

Clinical Research Associates can work on various stages of a clinical trial, performing tasks such as creating trial protocols, developing trial methodology, collaborating with ethics committees, liaising with doctors running the trial, making visits to the trial site, ordering supplies, monitoring expenses, and authenticating data collectioClinical Research Associates can work on various stages of a clinical trial, performing tasks such as creating trial protocols, developing trial methodology, collaborating with ethics committees, liaising with doctors running the trial, making visits to the trial site, ordering supplies, monitoring expenses, and authenticating data collectioclinical trial, performing tasks such as creating trial protocols, developing trial methodology, collaborating with ethics committees, liaising with doctors running the trial, making visits to the trial site, ordering supplies, monitoring expenses, and authenticating data collection forms.

-- Updated case reports and source documents for clinical trials, arranged study interviews, and recruitment — Updated medical records, maintained information on protocol and case reports for each trial, developed flow sheets and identified subject eligibility — Performed QA / QC procedures, worksheets and study materials, collected data and ordered supplies — Prepared consent amendments and processed specimens — Prepared sponsor files for FDA compliance and GCP guidelines

Operationalized Phase III & IV clinical trials with responsibility for protocol designs, site and vendor selection, resulting in on - time delivery of clinical study results.

• Identify potential clinical study subjects by reviewing existing health information based on inclusion criteria • Interview potential subjects to determine their suitability for study trials • Carry out informed consent processes by assisting with registration information and records management • Ascertain that established clinical study protocols are implemented and maintain protocol integrity • Monitor participants» status by ensuring their safety and educate clinical staff on outcomes and expectations

Tags for this Online Resume: Instant Messaging, Data Analysis, Document Management, Good Clinical Practices, Good Laboratory Practices, Management, Medical, Medical Terminology, Microsoft, Microsoft Excel, Data Entry, Site Feasibility, Trial Master File Audit, Trial Master File, Routine Monitoring Visits, Bilingual, IWRS Systems, DSMB, analysis of PK data from different generations of Japanese subjects, Receiving Plasma samples and storing them in freezers, Urine collection and UA testing, Phlobotemy, ECGs, Dosing, Writing Visit Reports, Query data sheets, Resolving Queries within the SOP allotted time frame, Pippetting Fluids and shipping off with appropriate courier., CRA visit matrixes, Reporting numbers and statistics to Project Manager and Operations Manager, Reviewing Source Documents and making original source documents according to procedures in the protocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverableprotocol, Protocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverableProtocol review sessions, QA sessions daily with a volunteer from each department to go over daily data and tasks to make sure none were missed, Call subjects and perform AE checks according to timelines on protocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverableprotocol, Send critical documents to sites directly or through CRAs as demanded., Make progress matrices of site visits and site reports, Send reminder emails for upcoming visits for CRAs and internal deliverables, Coder

All protocols accept, but do not require, evidence based on randomized controlled trials, and most others accept clinical controlled trials as appropriate sources of evidence.