WorkSure wishes everyone Happy New Year 2022
#contractresearchoganization #clinicaldatamanagement
Friday, 31 December 2021
Saturday, 14 November 2015
Pharmacoeconomics: quantify the value of pharmacotherapy through balancing costs and outcomes
Monday, 5 October 2015
Excellence in regulatory documentation rendered by medical writer
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.
Monday, 28 September 2015
Regulatory Medical writers A Document Focused Scientific experts
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| WorkSure |
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.
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.
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.