Sentences with phrase «clinical study reports»

Assisted in writing clinical study reports, with supervision.

Researchers from the Nordic Cochrane Centre, Rigshospitalet, Copenhagen, Denmark, looked at clinical study reports from the European Medicines Agency to assess the benefits and harms of using this drug for stress urinary incontinence.

Such sweeping glasnost doesn't appeal to the pharmaceutical industry, which is concerned that disclosing clinical study reports could open data to potential competitors.

The European Medicines Agency is making good on a promise to become more transparent and hopes to release clinical study reports.

A prospective clinical study reported that 15.4 % of French Bulldogs were affected by corneal ulcers [8], with conformational risk factors for corneal ulcers across dog breeds also identified in the same study.

Prepared and maintained the data management documentation for the preparation of clinical study reports for NDA submissions

Core Competencies CDMS • Adverse Events • Single and Double Data Entry • Data Coding • Clinical Study Reports MedDRA / WHOART Dictionaries • Medidata RAVE Data Capture • eCTD • Data Validation

Assisted in writing Clinical Study Report.

«To be sure, there have been no clinical studies reporting a lower risk of prostate cancer in people currently taking antidepressants,» said Wu.

Clinical study reports, examined by Cochrane reviewers such as Doshi, suggest they weren't always, he believes.

But Dr. Nav Persaud, a researcher and family physician at St. Michael's, said the manufacturer's detailed 9,000 - page «clinical study report» he obtained from Health Canada specified that the findings would be clinically important only if there were a three - point reduction in symptoms.

Experience writing, editing, reviewing and formatting clinical regulatory documents (e.g. clinical study protocols, clinical study reports and investigator brochures).

Prepare Coordinate, review and finalization of various clinical operations / trial - related documents (i.e., Trial master file, protocols / amendments, informed consent forms, Study operations manuals / sheets, advertisements, data management / analysis plans and clinical study reports) according to ICH - GCP guidelines and CFR Part 11 for completeness, accuracy and legibility.

• Devised a clinical study reporting system, which took 50 % less time in developing reports.

Responsibilities include generating, completing, & finalizing all clinical study report appendices, ensuring correct file naming, and collecting & verifying drug batch information.

Tags for this Online Resume: Data Management, Management, Nephrology, Clinical Research, Clinical Study Reports, Drafting, Oncology, Project Management, Project Manager, Protocol