Saturday, 14 November 2015

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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Monday, 5 October 2015

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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Monday, 28 September 2015

Regulatory Medical writers A Document Focused Scientific experts


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 WorkSureTM 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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Saturday, 3 January 2015

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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Friday, 28 November 2014

Clinical Data Management System Helping to fast-track the drug development process

Clinical Data Management System

In today's research scenario, clinical trials find answer to the research questions by the means of generating data for proving or disproving a hypothesis. This produces large sum of clinical data which has to be organised in most reliable and flexible manner under an efficient management system called as Clinical Data Management (CDM). Clinical Data Management Services has now gradually developed its response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to put the quality systems in place to ensure generation of high-quality data for accurate drug evaluation. The main objectives of CDM process is to collect the raw data, ease in monitoring or auditing, and to facilitate processing of the data.

Clinical Data Management System CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards and thus adoption of CDM to drive forward drug research is gaining pace worldwide. It is found that CDM is the key corporate asset in today’s biopharmaceutical industry, and turning data into meaningful information is a critical core function for sponsor firms to make faster and more flexible assessment of the compounds with a specific indication. In forthcoming trials, a CDMS has become necessary to manage the huge amount of data. Many of the CDMS used in pharmaceutical companies are commercial, but there are few open source tool also. These CDM software are available free of cost and are as good as their commercial counterparts in terms of functionality. The open source software can be downloaded from their respective websites.

Electronic Data Capture (EDC) is an alternative which helps to reduce the clinical research cost by 20-28%. The use of EDC technology and eCRF to collect data in clinical trials has grown in recent years and has affected the activities of clinical research operations for industry sponsors, contract research organizations (CROs), and clinical sites. It is found that cost savings alone with EDC vs paper estimated about $60 million per drug. To encounter the particular demand, there is a constant shift from the paper-based to the electronic systems of data management. Developments on the technological front have positively impacted the CDM process and systems, thereby helping encouraging results on speed and quality of data being generated.

While companies are seeking faster access to clinical data, the integrity and quality of data being collected and transferred from study subjects to a clinical data management system (CDMS) must be monitored maintained, and quantified. This ensures a reliable and effective base for not only new drug application (NDA) submission and clinical science reports but also corporate clinical planning, decision-making, process improvement, and operational optimization. FDA has brought forward a critical path initiative in pushing study data tabulation model (SDTM) adoption to enable electronic regulatory submissions for sponsors of human drug clinical trials. SDTM was initiated and developed by CDISC. As a consequence, biopharmaceutical companies have been going major changes in re-evaluating their IVRS, CDMS, clinical trial management system (CTMS), and clinical safety system (CSS) to accommodate the growing needs and demands.

In conclusion, CDMS has now been emerged as an important and reliable tool to materialize the clinical data into useful information which can be further considered to establish as research evidence. Moreover, speed and efficiency of CDMS has also contributed to fast track the drug development process.

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Wednesday, 12 November 2014

Electronic health records

The Health care industry has undergone dramatic changes over the last few decades. Most of changes revolve around gathering of information and these changes undoubtedly affect both providers and patients. The use of information technology gives access to gather health related information systematically and thereby improves the quality and efficiency of patient healthcare. With the emergence of EHR, the doctors can now instantly access the complete medical information and clinical records of patients on a routine basis.

An Electronic Health Records (EHR) is a digital record of an individual patient collected in computerized format in order to share medical report among multiple healthcare agencies. Digitized health information is a developing concept which can provide very effective and quality solutions for patient care besides helping in reducing costs.

The system is designed to feed all the appropriate conditions of an individual patient or population in a digital format that is theoretically shared across different health care settings. Sharing can also be done by means of network-connected, management information systems and other information networks or exchanges.

In other way, Electronic health record is a source of communication between multiple health care providers to organize, store and manage health data as well as to coordinate a safe, secure and accurate data of an individual patient.

This record constitutes the heart of e-Health that can be implemented for various public health programs for achieving human development in the field of health sector.

Among other types of data, an EHR typically includes:

  1. Contact information.

  2. Medical history of patient.

  3. Medication and allergies.

  4. Insurance information.

  5. Immunization status.

  6. Information about any conditions or diseases.

  7. Records of hospitalization.

  8. Information about any surgeries or procedures performed.

  9. Billing information.

  10. Family history.

The governments of many countries are working to ensure that all citizens have standardized electronic health records including the same type of information. However, the major barrier for the adoption of electronic health records is due to high cost involvement.

Functions of Electronic health record systems:

  1. Create unique record for each patient including analysis of demographic information of patients
  2. Helps in updating patient history
  3. Act as source of communication between the professionals and patient records.
  4. Lists patient allergic medications and other factors and helps in separating these drugs from a list of common drugs
  5. Stores all the data right from the early stage to the final and provides whenever needed
  6. Has the ability to register without re-entering medication order by initial data entry from previous data (template for reuse)
  7. Allows storing of laboratory results and displays the normal and abnormal results
  8. Describes & documents the oral communications and telephone orders for patient

Advantages of Electronic Health Record

  1. The entire patient history can be easily viewed without previous medical records and assists in providing accurate, appropriate and legible data.
  2. The chance of replication or duplication is reduced as there is only one single file which is constantly updated and it also eliminates the problem of lost forms or paperwork.
  3. It is an effective method for extracting medical data for further changes in examination of the patient’s medication profile.
  4. Medical records of more than one patient can be easily extracted from EHR database and can be used to gain common characteristics information for other patients, which help in easily and quickly prediction of a disease.
  5. Electronic health records are capable of storing, processing or transferring data to the physician far from their patients simultaneously by proper equipment information and communication technology.
  6. Electronic health records are very much in demand in healthcare practice and enables professionals to interact with each other effectively. The health data management services mainly use EHR for storing all the information.

Implementing an EMR system

Implementing an EMR system requires careful planning and strong knowledge of trained staff. The following can help make successful implementation of an EMR system at your office.

  1. Choose your TPA(third-party application) carefully
  2. Ensure connectivity
  3. Develop workable templates
  4. Training the Staff
  5. Establish data security system
  6. Prepare EHR details
  7. Create harmony between the standard organizations and all interested groups and sub-organizations.

Barriers to implementing an EHR system

  1. Incorporation of older paper data into the EHR system
  2. Imprecise preservation and long term storage of records
  3. Difficulty in Synchrony records
  4. Inadequacy of Privacy concern
  5. Incompatible with older technology
  6. Software maintenance costs
  7. Higher costs involved in implementation of a customized system initially.

Due to the challenges and complexities of electronic health records, few people feel uneasy about using electronic medical record software for storing their medical data. On the other hand, there are many people who prefer electronic health records as they feel there is nothing better than digital documentation.

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