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… synopses and writing study protocols and analysis plans to use in regulatory discussions Advising on benefit-risk … Conducting epidemiological research related to pregnancy Based on your needs, we provide consulting support …
… Drug Safety in Pregnancy Satisfy Regulatory Requirements With Help From Our … the safety of your product if pregnant persons might use it. Typical requests from regulatory agencies include … data collection and studies that make secondary use of existing data sources—using real-world data to …
… Informing Gestational Age in Pregnancy Research without Clinical Estimates Distribution of … of singletons, regardless of maternal age, smoking in pregnancy, or maternal body mass index. Gestational age at … research provide information that other researchers can use to estimate the duration of pregnancy in database studies …
… of life, functional status, and patient satisfaction for use in clinical trials involving both pediatric and adult … In addition, we have experience developing COAs for use in routine clinical care, such as patient screeners and … including regulatory submissions, reports, and publications Support to secure regulatory acceptability of …
… Publication Management and Medical Writing Publications are critical for the dissemination of your … and internal milestones is an integral part of the publications process. We develop a customized timeline for … managers submit publications to journals across the spectrum of scientific and medical fields. We have favored …
… perspectives of patients and care partners across the AD spectrum. When companies follow a patient-focused … including items related to memory, orientation, function, and emotional well-being. This suggests that … well-being is likely as important as cognition and function to patients and care partners across the AD …
… Identifying a Drug's Safety Profile Antiepileptic drugs in pregnancy, and duration of pregnancy, birth weight, length, and head circumference … Health Solutions, has explored the association between the use of antiepileptic drugs in pregnancy and pregnancy …
… for Comparative Safety Research Antiepileptic Drugs in Pregnancy: Searching for a Reference Drug for Comparative … Around 0.5% of women in Europe and 2% of women in the US use antiepileptic drugs during pregnancy. It is important to … study. Our literature review shows quite clearly that the use of carbamazepine in pregnancy increases the risk for …
… Suggests Century-Old Hypothesis on How Major Arteries Function is Incorrect Share on: September 17, 2017 Emergence …
RWE Studies Using Primary Data Collection To meet the requirements of risk management programs, inform drug development and post-approval strategies, or answer epidemiologic questions, we can help you design and implement real-world evidence research …