These forward-looking statements include statements regarding the possibility of resubmitting the Contrave NDA with the DMC report on the interim analysis and without the clinical study report
for the interim analysis; the potential to accelerate the timing of the review of the Contrave NDA; the potential for, and timing of, the accrual and adjudication of MACE and the potential resubmission of the Contrave NDA; the safety and effectiveness of Contrave; the potential for past Contrave clinical trials to predict the outcome of future Contrave clinical trials; the potential to demonstrate the real world weight loss potential of Contrave with a commercially available comprehensive lifestyle intervention program; and the potential for, and timing of, approval for Contrave.
Nikiforos Diamandouros has branded EMA guilty of maladministration when refusing Danish researchers access to clinical study reports
and trial protocols for two anti-obesity drugs, not named in his ruling.
It also incorporates safety management and reporting, monitoring the trial, managing trial data, quality assurance of the trial performance and recording the data and guidance for preparing clinical study reports
Research and development: These personnel are most familiar with clinical trials and clinical study reports
is required clinical train professionals in the principles of evidence-based medicine, critical analysis of clinical study reports
and monographs, development of drug economy, to support better decisions in general
TransCelerate") today announced that it has developed a recommended approach for protecting personal data in Clinical Study Reports
(CSRs) that are shared with researchers, patients and others.
Cognizant (NASDAQ: CTSH), a leading provider of consulting, technology, and business process outsourcing services, today announced a multi-year agreement with AstraZeneca to deliver comprehensive biostatistics and medical reporting services to generate clinical study reports
Joining the electronic platform and providing access to anonymized patient-level data, protocols and clinical study reports
is a further step towards increased transparency while maintaining patient privacy.
Under the agreement, YODA will independently review and make final decisions regarding all requests for the company's clinical trial data including clinical study reports
(CSRs) and de-identified patient-level data.
In the news release, "Revlimid(R) Clinical Study Reports
Survival Advantage for Patients Newly Diagnosed With Multiple Myeloma at European Hematology Meeting" issued on 11 Jun 2007 11:38 GMT, by Celgene International Sarl nasdaq:CELG over PR Newswire, we are advised by a representative of the company that there were numerous errors in the press release as incorrectly transmitted by PR Newswire.
The Company said that it will provide access to clinical trial data and related documents, including Clinical Study Reports
(CSR), for studies sponsored by Sanofi companies that conduct clinical studies in humans.
In addition, he has worked on the preparation of clinical study reports
for Regulatory submissions, meeting abstract and journal publications as well as performing exploratory analyses for promotional response marketing modeling used for materials for sales representatives.