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. Regulatory medical writing has grown complex with the introduction of new requirements for drug approval.
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Medical writing is the process of writing scientific or regulatory document by specialized writers known as the “medical writers”. Medical writers might not be the real scientists who did the authentic research, but work with the physicians / scientists concerned in the creation of data, and thereby assist to present that data in appropriate and clear way. The importance of good medical writing must not be ignored as science depends on clarity and accurate reporting, otherwise meticulous research can appear imperfect if poorly presented.
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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. Thus medical affairs has evolved into a separate medical organization that often sits within development organizations but primarily works on post approval activities and has both the scientific and clinical expertise to support commercial products.
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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. It is indeed a challenging task for the pharma companies too who are looking for key opinion leaders (KOLs) to assist them in exploring, launching, and promoting new drugs. KOL’s provide important information on disease condition and patient medication regimen.
Continue reading Managing KOL relationships helpthe strategic solutions for the new and existing medical therapies
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. After that clinical trials establishes new molecule (IND) as a drug and also provide information that how drug acts on underlying diseases.
Continue reading Clinical trials translate fundamental research into medical care
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. Data Validation may be defined as the way of calculating a system or section in between or at the end of the development process to find whether it complete particular requirements. Validation signifies that the system is functioning and checks that the software complies with the needs which were mentioned at the starting of the software development cycle.
Continue reading Clinical Data Validation Ensuring the integrity of the Data
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. No troubles either minor or major should be avoided as they may cause imbalance of true data and its analysis or conclusions. Finding solutions to these problems will definitely lead to confirmation of data accuracy and its analysis.
Continue reading Clinical Data Management: Ensuring regulation and accuracy of clinical trial data
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. It also now faces an elevating attention from the safety and regulatory sectors, which have never been seen earlier.
Continue reading Clinical Data Management System A tool for gathering data and making clinical trials productive
Clinical data management comprises distinct process encompassing development and execution that is used in order to save, deliver and enhance the data/information in clinical research arena. Large amount of data is generated during the clinical trials which are recorded by medically qualified experts or investigators. Since many of the clinical trials are multi-centric, it is very obvious that investigators of diverse ethnic background are involved in the study which may leads to the recording of clinical data or medical data in different fashion.
Continue reading Medical coding: Correctly classify the medical terminologies during Clinical Data Management
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.Clinical data management (CDM) includes database entry, verification, quality control and validation of the clinical trial data.
Continue reading Clinical Data Services: An Approach to Centralize Innovative Research Strategies