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Priya Sharma

Clinical Data Coordinator. Clinical trials generate an extensive amount of statistical data.

Clinical Data Coordinator

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. Clinical data services division ensuresa consistent flow of data and constant communication with the project teamto comply with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards.Data management team prepares application for the data entry, design edit checks to protect against entry errors, generate and resolve the data queries. Medical team helps in validating the data, generating code for administrative reports and exporting data for the statistical analysis.

Medical Marketing – Pharma marketing the advertising strategies. Medical-marketing or pharma-marketing is a term used for implementing the advertising strategies by pharmaceutical/biotech/medical device organizations for the promotion of their brands and products and meet the sales target.

Medical Marketing – Pharma marketing the advertising strategies

Besides, it also helps to regularly update the pharma-healthcare professionals about safe and effective use of the new drugs and devices available in the market. A pharmaceutical sponsors who invests a huge amount on discovering a drug, expects monetary profit in return. Well planned marketing strategies and enthusiastic sale is required to promote the product in market which fetches corporate profit to the sponsor. However, scientific knowledge is required not only to support the marketing but at very first step, to provide the rationale of marketing. Medical Communication Companies.

Clinical research generates huge amount of knowledge which is supposed to guide clinical judgement and decision making when implemented wisely.

Medical Communication Companies

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. This could be achieved by an efficient channel of communication. Medical communication involves disseminating the medical knowledge mainly among the healthcare professionals and the public but largely among all the stakeholders including policy makers and managers.

Medical Writing Companies - Medical Manuscript Writing Service. 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.

Medical Writing Companies - Medical Manuscript Writing Service

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. Planning an article should begin with appropriate literature search and identification of reliable source of information. In order to frame and construct a quality manuscript, it is recommended to apprehend the topic well by thorough literature review. Literature search thus ends up with a collection of unorganized raw information which is further shaped and constructed in a defined order. The framed material should be glued together in meaningful paragraphs, enabling the medical writer to convey the ideas effectively to the reader. Medical Writing Companies - Medical Manuscript Writing Service. Clinical Research. Clinical research involves investigational studies conducted upon human volunteers, intended to unravel new therapeutic options to medical world.

Clinical Research

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. In addition, the safety and efficacy profile of the intervention is also evaluated to measure certain outcomes in the participants. Every clinical study is led by a principal clinical investigator who heads a team of doctors, nurses, other health care professional social workers. Clinical research can be sponsored by pharmaceutical companies, academic medical centres, voluntary groups, and other research organizations. Physicians, health care providers, and other individuals can also sponsor clinical research. Medical Legal Cases. In today’s world, medical practitioners often unexpectedly meet up with medico legal issues.

Medical Legal Cases

This is due to the fact that every registered medical practitioner is expected to perform some medico legal duty. Several cases of criminal negligence are being registered against these professionals. The rise in medico legal cases (MLCs) is owing to decrease in patient’s faith and trust on doctors. A medico legal case/issue can be any case in which a person is harmed or injured in any way and involves legal authorities. Thus, proper handling and accurate documentation of these cases is crucial to avoid legal complications. Medical Writing Agencies - Medical Writing Agency - Medical Writing Company. Biomedical researches, conducted by various organizations are required to be documented in accordance with regulatory and public requirements.

Medical Writing Agencies - Medical Writing Agency - Medical Writing Company

Medical writing is a specialized technical writing that generates explicit documents as per standard operating procedures to suit target audience. Various organizations, termed as medical writing agencies share this onus with sponsors by dealing with the services related to both regulatory and commercial conceptualization pertaining to clinical as well as marketing phase. Medical Affairs Services - Medical Affairs Consulting Services. Medical Affairs is responsible for developing and implementing medical tactics and strategies for promoting a brand or therapeutic area.

Medical Affairs Services - Medical Affairs Consulting Services

Personnel in the medical affairs department work in close association with sales/ marketing and healthcare professionals with a key function to promote brands/products specific scientific and medical information for an organization. Pharmacovigilance - Pharmacovigilance Services. Different countries and regions across the globe witness varied patterns in drug effects and reactions.

Pharmacovigilance - Pharmacovigilance Services

This occurs due to differences in diseases, genetics, diet, prescribing practice, local traditions and drug manufacturing process impacting its quality. Few of these effects are untoward and noxious termed as adverse events. Such events are unwelcomed not only for patients but also for manufactures. Since, regulatory authorities keep a close eye on these occurrences even after the marketing approval of a drug and may take preventive steps to ensure public safety which might even include withdrawal of drug from market. A systematic system of adverse event surveillance, practiced by sponsors under regulatory monitoring is called pharmacovigilance. Clinical Research and Data Management: Approach to Drug Discovery.

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 and Data Management: Approach to Drug Discovery

Preclinical and Clinical Trails - the backbone of Drug Development Process. Preclinical or nonclinical studies, is a stage of drug development process which begins prior to the humans testing of investigational drug (Clinical trials). Preclinical studies approve or reject thein silico conceptions of drug’s efficacy in biological system. Preclinical studies are conducted in animals to explore the early efficacy of investigational product through pharmacodynamics and kinetics testing.

Moreover, thorough investigation of drug’s safety is performed which includes organ system toxicity, besides potential hazards of carcinogenicity, mutagenicity, and teratogenicity. The preclinical findings form the basis of clinical research and allow researchers to estimate a safe starting dose for human testing. Clinical trials involve healthy human volunteers or patients depending on its stage of testing. U.S. Preclinical trials provide the first substantial, biological data by testing the drug in animals and lay down the foundation for clinical studies.

Clinical Data Management. A regulatory approval is highly unlikely without the support of valid and reliable data. Clinical data, thus determine the fate of investigational molecule and its prospective position in therapeutics. Therefore, it is vital to transform clinically generated data into productive and statistically reasonable clinical assets by application of Clinical Data Management. It is defined as “the development, execution and supervision of plans, policies, programs and practices that control, protect, deliver and enhance the value of data and information assets.” Clinical Data Management, being a cross functional operation; requires integration of scientific thoroughness, information technology, and clinical attentiveness. Untitled. Medical Writers - important for success of Clinical and Regulatory Document. Consistency is a key to planning and is supported by well-designed templates, boilerplate language, and style guides that are created by the medical writers to be used throughout the drug development process without dramatic revision.

Consistency is vital when discussing results and conclusions from a given study in multiple documents, and uniform data presentation between clinical study reports allows results and conclusions to be more easily combined when integrating the summaries. Such consistency can only be given by a well-structured and effective project team of medical writers who interacts on a peer-to-peer level with functional experts. The advantages of using highly skilled medical writers include the output of higher quality documents in less time, the transfer of the medical writing burden away from functional staff so they can focus on their primary roles and responsibilities, and cost savings in both the short- and long-term. Medical Service KPO An offshoot of Healthcare KPO. Knowledge Process Outsourcing (KPO) is a higher-end version of outsourcing business processes that require significant domain expertise.

Thus KPO emphasizes on services based on knowledge power. At present, major categories of domain knowledge that are working as KPO include legal process, research and development, market research, financial services research, business intelligence and medical services. Medical service KPO is a healthcare KPO, which, identifies and addresses the met and unmet medical needs associated with products, therapies and disease states in order to drive improvement in patient outcomes. Understanding-Pharmacovigilance-System-Processes. According to WHO “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” In other words the goal of pharmacovigilance is getting the best outcome of therapy by patient care and surveillance. Good pharmacovigilance System will identify the risks and risk factors related to adverse drug reactions (ADRs) during the complete product life cycle.

This information allows for intelligent, evidence-based prescription and has the potential for preventing ADRs. The importance of Pharmacovigilance. Good Pharmacovigilance System. The concept of pharmacovigilance practice is normally not well understood, either by health professionals, patients or the general population. Development of guidelines and standards are required for a coherent and good pharmacovigilance system, which describe the practical details of the intended information flow. Good pharmacovigilance systems should have the capability for receiving and processing of reports with verification, interpretation and case causality assessment. Preclinical and clinical research. Pre-clinical and clinical research; Phases of Clinical development. Facilitation Medical Research Communication (FMRC) Medical research in India is still limited to some apex medical institutes and central laboratories to a large extent.

India contributes a meagre 1.2% to the total published medical research, in nearly 6800 journals, worldwide. Moreover, approximately 70% of this research literature comes only from 10 medical colleges. The time is ripe enough to have more medical research centers which will focus on the diseases prevalent in our country for the benefit of mankind. Indian doctors see a large pool of patients in a day,but lack of proper inclination towards the medical research methodologies does not lead to any blockbuster outcome.

Also majority of data generated from medical institutes, hospitals & clinics does not get published due to various reasons. FMRC programme, an initiative of WorkSure, is a highly specialised programme providing customised solutions as per the needs of medical/healthcare fraternity. For more information about FMRC please do write to us at info@worksure.org. Medical Research - WorkSure MedPharma Consultancy India Pvt Ltd. Medical Education and Training. Medical Writing. Medical Affairs And Medical Reviews. Medical Marketing and business development. Clinical Research and regulatory activities. Training cum Workshop on Research Methodology - Worksure.

Home. Medical Affairs Management. Importance of documentation in Clinical study / Scientific Research. Documentation serves as a backbone for successful conduct of a clinical study or scientific research. A trail can be effectively generated only through proper maintenance of documents. Clinical Trial Application (CTA) Risk Evaluation and Mitigation Strategies & Risk Management Plan. Risk Evaluation and Mitigation Strategies (REMS for US FDA) and Risk Management Plan (RMP for EU) are two main risk management strategies required for medicinal and biological products to ensure that the benefits of a drug or biological product outweigh its risks without creating an undue burden on the healthcare system .

Risk evaluation and management strategies are required by the regulatory as part of the approval of a new product, or for an approved product when new safety information arises. It is a safety strategy which helps patient to manage a known or potential serious risk associated with a medicine or biological product and thereby allows safe use of the medicine. Medical Writing Essentials. Medical writing services communicates knowledge and data in healthcare. Healthcare Communication Agencies. Clinical Research and Clinical Trials Management.