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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.

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.

Clinically validated data is a valuable asset to pharmaceutical organization. Data from the clinical trials are vital to the whole clinical development procedure. Value of any drug cannot be properly noticed until the clinical data is systematically organised, simply accessible and cleaned.

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.

Clinical research generates huge amount of knowledge which is supposed to guide clinical judgement and decision making when implemented wisely. Studies show that a huge gap exists between the knowledge generation and its use in clinical practice. Therefore, in order totranslate knowledge into practice, knowledge generators must ensure that an uninterrupted access of end users to this knowledge.

Clinical research generates huge amount of knowledge which is supposed to guide clinical judgement and decision making when implemented wisely. Studies show that a huge gap exists between the knowledge generation and its use in clinical practice. Therefore, in order totranslate knowledge into practice, knowledge generators must ensure that an uninterrupted access of end users to this knowledge.

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.

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.

Clinical research involves investigational studies conducted upon human volunteers, intended to unravel new therapeutic options to medical world. When a new product or an approach is introduced, it is always being investigated whether it will be helpful, harmful or similar to available alternatives.

Developing a new medicine is a sophisticated and complex task which initially begins with the understanding of disease or condition as thoroughly as possible. At first, the researchers conduct studies in cells, tissues and animal models to determine whether the disease or condition can be influenced by new molecule.

The current global scenario recognizes regulatory medical writing as a tool to for developing authenticated documents related to products undergoing clinical trial. The purpose of regulatory medical writing is to offer the highest quality scientific documents for fulfilling the requirements of particular audience.

Medical writing conveys clinical findings from research labs to the masses in form of articles for publication, regulatory documents, and content development for pharma-healthcare magazines, newsletters and websites. The criteria of writing the medical content mainly depends upon the need of the end users for examples documents for the medical journals, physicians, healthcare organisations, pharmaceutical companies, etc.

Epic Sciences has announced an agreement with Laboratory Corporation of America Holdings (LabCorp) to expedite sample processing for Epic's circulating tumor cell (CTC) technology to support European clinical trials.

A pioneering study looking into the possibility of combining existing therapies to slow down cancer growth is showing encouraging early results. Elly Earls reports. A first-of-its-kind medical study at The Care Oncology Clinic on Harley Street, London, has started work on evaluating whether the use of a combination of safe, tolerable, existing, generic therapies could slow down cancer growth and improve survival times in patients for whom other treatments are no longer available or working.

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Research and development (R&D) in liquid biopsy is increasingly being funded by both public and private sectors due to its promising features such as early detection of cancer tumour, new lesion characterisation and identification of cancer drug target.

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