Clinical Resarch
Within the clinical research department, all efforts are invested according to the most up-to-date standardized procedures (SOP) to deliver services of feasibility of research project, protocols elaboration, submission to regulatory authorities, implementation, monitoring, validation and coordination of clinical biology services, pharmacovigilance monitoring , reporting and reconciliation of events , IMPs management , data verification and storage ; site closures and medical writing of end of study reports.
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Pharmacovigilance
The rapid induction in the market of new health products throws up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. All health products , pharmaceuticals, medicla devices, cosmetics and vaccines have potential side effects. Some of these side effects are known, while many are still unknown even though that medicine has been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of products in order to determine any new information available in relation to their safety profile ...
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Pharmacoeconomics
Economic, humanistic, and clinical outcomes of a drug , a device or a method , should be considered and valued using pharmacoeconomic methods, to inform local decision making whenever possible. Pharmacoeconomics identifies, measures, and compares the costs and consequences of drug therapy to healthcare systems and society.Healthcare costs can be categorized as direct medical, direct nonmedical, indirect nonmedical, intangible, opportunity, and incremental costs ...
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Biomarkers, Central Lab and Clinical biology services & QA
Biomarkers nowadays are largely applied to drug development in a number of distinct ways. First, they may be applied as additional diagnostic measures in a population clinically identified as having the disease. Sensitivity, specificity, and positive predictive value all must be considered for such an application.One of the most important uses of biomarkers in drug development is as an indirect measure of disease severity. A number of points should be established for such use: the marker must have a scientific rationale , it should change with disease progression in longitudinal observational studies, and must be measurable and reproducible.
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eHealth Solutions
In most healthcare settings today, nearly all insight into a patient’s health is lost the minute they leave the clinical care setting. The visibility into their health condition surfaces only when they return for a scheduled visit, or potentially worse, an emergency situation.With established technology and consulting services we help take remote patient concepts from the whiteboard to the real world. Many solutions can be tightly integrated with our care delivery solutions to offer a comprehensive patient engagement solution to health care professionals and drug/medical devices manufacturers sponsored programes ...
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