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In present state of affairs, clinical research is considered as one of the promising domains for any health care organization. Clinical research studies leads to the generation of data whose management is not an easy task to perform by any biopharmaceutical organization. Clinical Data Management System (CDM) is leading clinical development industry into a new innings of transformation.

The data management of a clinical trial is a crucial step for the firms that are undergoing research studies in the hospitals. Maintaining the quality and integrity of clinical data is yet another daring task to perform. Many of recent studies showed numerous troubles with data management system (DMS) in clinical trials performed at academic organizations.

As soon as a potential moiety is identified it is subjected to pre-clinical studies for determination of safety, efficacy, pharmacokinetic and pharmacodynamic profiles of molecule which are later extrapolated to human volunteers or clinical subjects under clinical research. Clinical research is carried out meticulously at academic blocks, healthcare organizations and research study centers affiliated by regulatory bodies.

Germany-based OctreoPharm Sciences has received Orphan Drug Designation from the European Medicines Agency (EMA) for OPS202 as a diagnostic agent for the management of patients with gastro-entero-pancreatic-neuroendocrine tumors

Clinical trials generate an extensive amount of statistical data. With the increasing complexity of segregated data collection, it is imperative to have an effective system to manage and to statistically analyse the data to produce end result. Clinical data management system (CDMS) is used for this purpose.

The current competitive environment demands tactful management of most respected and skilled physicians by the healthcare organisations. Hence each healthcare organisation is making an ardent effort to ensure that no stone remains untouched. The fact of matter is not only true for the health care industry, but also for pharmaceutical companies.

Medical Affairs has originally emerged as a reaction because of increasing pressure from regulators to separate medical and commercial functions. Companies have been experiencing increasing internal demand to focus on generation and development of new products rather than managing products after FDA approval.

Medical Affairs team works closely with the clinical development team for planning and organizing clinical development plan, protocol development, investigator selection and meetings, ongoing data maintenance and management, statistical analysis & interpretation, report writing activities etc. They are involved in pharmacovigilance, regulatory support, post marketing safety and surveillance studies.

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