Pharmacoeconomics: quantify the value of pharmacotherapy through balancing costs and outcomes

Pharmacoeconomics (PE), a sub discipline of health economics, evaluates the behavior of individuals, firms, and markets relevant to the use of pharmaceutical products, services, and programs, and with the focus on the costs (inputs) and consequences (outcomes) of that use. Cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis and cost-benefit analysis are the four techniques commonly used for economic evaluation, but vary in measurement of value of health benefits and outcomes. PE assessment of formulary actions has become a standardized part of many pharmacy and therapeutic committees (PTC). PE studies are also helpful in fixing the price of a new drug and re-fixing the price of an existing drug, finalizing a drug formulary, creating data for promotional materials of medicines, compliance of requirement for drug license, including a drug in the medical/insurance reimbursement schemes, introduction of new schemes and programs in hospital pharmacy, drug development and clinical trials PE has use in health policy decision making and can be applied by a number of healthcare professionals such as policy makers, primary healthcare providers, health-care administrators, and health managers.

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Excellence in regulatory documentation rendered by medical writer

Regulatory Medical writing is an activity of writing scientific documents which are pivotal for the approval of any new drug or device. A team of specialized medical writers are involved in the preparation of Investigational Medicinal Product Dossier (IMPD), Clinical Trial Application (CTA), Common Technical Document (CTD), Investigational New Drug (IND) & New Drug Application (NDA). The regulatory medical writers must have the good knowledge of new and changing global regulations and ICH guidelines to meet the requirement of sponsor. At WorkSureTM we have the capability to work for regulatory framework of various countries including USA, Canada, Europe, Japan, India etc.

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Industries are helping medical research and communication activities

Newer treatments and bettering healthcare services are increasing life expectancy with improved quality of life. Various pharmaceutical, biotech industries and medical service KPOs are stepping forward to facilitate delivery of evidence based health care to the patients. WorkSure™, a growing name in healthcare KPO, has taken FMRC (Facilitated Medical Research Communication) initiative to help bridge the gap and increase India's share in biomedical research. This unique program is specially designed for assisting the Healthcare Fraternity to promote medical research at the level of hospitals, clinics as well as individual physician. WorkSure™ also promotes public private partnership in medical research and drug development.

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Regulatory Medical writers A Document Focused Scientific experts

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Medical writer plays an important role in providing information to the targeted audience.  Regulatory medical writing involves regulatory documents that are required before the approval of drug. All new drug or chemical entity undergoes many level of test for its purity, safety and efficacy. These include clinical study protocol, clinical study report, patient consent form, summary document (common technical document).  It is an internationally agreed format for the preparation of applications regarding new drugs. It was developed by EMA, Europe (European medical agency), FDA (Food and Drug Administration), MHLW, Japan (Ministry of Health and Labour Welfare). The CTD is maintained by ICH (International Conference of Harmonisation). The regulatory documents required are INDA (Investigational New Drug Application), NDA (New Drug Application), and ANDA (Abbreviated New Drug Application. The regulatory writer prepares the document to be reviewed by FDA and for further proceeding with the clinical trials. The strength of medical writer depends on its experience and ability to understand well the regulation requirement by the corresponding agengies. Other regulatory documents like Product Monograph, Full Prescribing Information, Patient Information Leaflet, Summaries of Product Characteristics (SPCs), Risk Evaluation and Mitigation Strategies (REMS) etc. for both drugs and devices also be a part of regulatory document. The drug safety, quality, strength and purity is assured by NDA to permit FDA for final submission.

The regulatory medical writer is an expert and more specific than any other writer as they have to deals with the regulations in ICH which involves application submission, withdrawal and termination of particular drug. The regulatory medical writing team also involved in preparing dossier, protocols for all clinical trial phases and application for INA, NDA, CTA.  As the detailed study of the drug is to be compiled and documented, the writer must know about the statistical analytical processes (SAP). They must be having good knowledge about the new regulations and amendments in ICH. In pharmaceutical organisation and clinical research organisation, the writer must be active to submit the information to the regulatory agency when needed. The medical writer has the primary responsibility for documentation of the specific areas such as CMC (Chemistry Manufacturing Control), clinical and non-clinical. After the protocol development at the clinical sites, the regulatory medical writer review SAP, followed by clinical study report. The writer has ability to complete and concise CSR that shows the result of clinical trials. Finally the results of each CSR are to be submitted to the regulatory authority. This procedure from developing protocol to the submission of document is undertaken by regulatory medical writer. The work of regulatory medical writer is wide-ranging. They have to face many challenges in pharmaceutical and clinical research organisation. As an individual they have to look into the protocol design in order to produce proper data out of the clinical trials necessary for labelling of product, support in data analysis, and summarises the complicated data. Additionally, Regulatory medical writer is always anticipated in the query resolution and for advancement to the sponsors.

We at WorkSure^TM have a specialized team of regulatory medical writer. We deal with all type of regulatory document IND, NDA and CTD. We are also involved in generating protocols for all phases of clinical trials. We have the capability to work for regulatory agencies of various countries including USA, Canada, Europe, Japan, India etc.

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WorkSure one stop guide for Medical Writing service

Medical writing involves communication of clinical and scientific data to wide range of audiences in various formats. A competent medical writer is one who has thorough knowledge of medical concepts and terminology, understanding of guidelines, flair for writing skills and good command over the language. Medical writers combine their scientific and rhetoric skills in order to present the information in accordance with the target audience. Medical writing involves writing of different documents viz regulatory and research-related documents, publication articles like journal manuscripts and abstracts, educational and promotional writing, content for healthcare websites, health-related magazines or news articles.

Medical writing for the pharmaceutical industry comprises of either regulatory medical writing or educational medical writing. Regulatory medical writing involves preparing scientific documents for submission to regulatory agencies for getting approval of pharma drugs, medical devices & biologics. They include clinical study protocols, clinical study reports, patient informed consent forms, investigator brochures and summary documents e.g. in common technical documents that summarize and discuss the data a company gathers in the course of developing a medical product.

Educational writing is one which describes the profile of drugs or devices to the general audience or to a medical professional. It also includes promotional writing. Promotional writing mainly comprises of product profile writing, drug related educational & promotional literature, ads etc. used by the healthcare industries for promoting their products. It also includes sales literature, product information leaflets, summary of product literature, journals, articles, manuscripts, slide presentation for conference.

WorkSure™ MedPharma Consultancy (WMC), a first Medical Service KPO in India, comprises of a team of enterprising, highly qualified and experienced professionals who are committed to achieve complete client satisfaction through timely quality work. We at WorkSure™ support in planning, performing and communicating research through preparation of various clinical, promotional, regulatory and educational documents.

WorkSure, a first Healthcare Service KPO in Indian, is a group of highly qualified and experienced professionals from top institutions of Indian like AIIMS, PGI & IIT. We work on three business models. First of all as efficient knowledge partners with dedicated group for medical composing, medical matters, medical information control, biostatistics, pharmacovigilance & coaching.

Secondly, we offer personalized stand-alone alternatives in pre-clinical & medical scientific research. We offer medical composing alternatives for planning of safety reports like ICSR, PSUR. We offer mathematical research of report/data and regulating support solution. We offer regulating alternatives for planning of Clinical Trial Program (CTA), Investigational Therapeutic Product File (IMPD), Investigational New Medication (IND) & New Medication Program (NDA), medical information alternatives and KOL control.

Thirdly, we have end to end alternatives for medical composing, scientific research coaching and site development, medical information control (CDM) and biostatistics for pre-clinical, medical and scientific research.

We offer a specific package for handling medical information right from information control plan to its removal for research and final confirming, with helpful mathematical & medical composing alternatives. With such a variegated outdoor umbrella of specific alternatives, WorkSure is an growing leader among Clinical Research Companies setting new requirements in this field.

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