WorkSure – Advisory Board Services

 

WorkSure Offers the Advisory Board Services
1. Knowledge Sharing with Healthcare StakeHolders of a Pharma.
2. Better understanding & interpretation of the various medical benefits/limitations of a drug/product/services.
3. Gaining non-binding but informed guidance on various business Aspects of a Drug/product/services.
4. Prior insights on possible research opportunities including guidance on the clinical development & trial Protocols as well as health care needs that might drive future clinical strategies.

Medical Knowledge Ensures Data Applicability in Clinical Data Management

A huge amount of data is generated through various phases of clinical research. The data has to be proficiently managed in order to draw relevant conclusions, file regulatory submissions and publish results and findings in research journals. Clinical Data Management (CDM) is the mainstay of clinical/medical research process needed for collection, interpretation and analysis of clinical data.

CDM is a specialized job which demands expertise in working with tools and knowledge of standard procedures and guidelines practiced by organizations dedicated to this field. Competency in medical writing with good statistical and medical knowledge provides an extra edge in collection, management and interpretation of data. Various modern and sophisticated practices involve the use of software designed exclusively for CDM and remote data capture (RDC), e.g. ORACLE CLINICAL, SAS clinical software and open source software like open CDMS(clinical data management services), Trial DB etc. Various available tools provide the basic help of on-site/remote data capture, managing, maintaining, retrieving data and even report generation. However, quality mainly relies upon how well the medical knowledge has supported the IT team at all stages of application development, data validation, analysis and interpretation reports. Therefore the quality of data and its applicability rest on the guidance of medical team.

After development of data management (DM) plan, first step that medical team performs is case record form (CRF) preparation. A concise and clear CRF is necessary for accurate data collection. Traditionally the paper version of CRF is used though electronic version also exists where investigator could directly enter the responses by accessing electronically. Once filled, CRFs are received and reviewed by data associates for any error or missing pages. Then data entry is done which could be made by two individual operators in order to negate the errors and omit any scribbled data. It is observed that data entry by two operators on paper CRF is more effective. Data once entered is tested for its synchronization with specifications of protocol and for inconsistency. Data discrepancy is checked by edit check programs, those might arise due to irregular data or any conflict with protocol.

Once identified, discrepancies are resolved by identifying their cause of origin, few of those which cannot be resolved are termed unworkable. This is most vital part of CDM (Clinical Data Management) process with the help of medical knowledge as it produces the clean data. Data is thus cleaned and discrepancy is stored in discrepancy database. Periodic reviews are made by CDM team to ensure that all the discrepancies are resolved. Coding is performed using electronic dictionaries to classify the reported terms on CRF into medical terminology. Two dictionaries are most widely used, World Health Organization–Drug Dictionary Enhanced (WHO-DDE) is used to code the medications while Medical Dictionary for Regulatory Activities (MedDRA) is used to code adverse events and pathological terms. After completion of all these tasks and ensuring resolution of data discrepancies, database is locked. Once locked, any modification in database is not possible hence an approval for locking should be seeked only after confirming that the data is completely clean.

At WorkSure™ we offer a specialized package for managing clinical data from development of data management plan to its extraction for analysis and final reporting, with supportive statistical and medical writing services. Thus WorkSure CDM team designs CRF, develops application, validates data by programming edit checks, codes adverse events and medical terminology, checks accuracy of data, resolves discrepancy, cleans and produces error free data. In the modern research oriented pharmaceutical industry, an efficient CDM is essential for skillful maintenance of data, enabling efficient regulatory submissions and interpreting clinical outcomes. Though advent of new tools and software provided new horizons to this field, medical knowledge lies in the core of CDM and data applicability.  Implementation of new and updated guidelines has standardized the process and helped to regulate the practices as demanded by regulatory authorities.

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Clinical Research Organization – WorkSure

WorkSure is a Clinical Research Organization. Since its formation we have been offering drug and device development services to pharmaceutical and bio technology companies worldwide. Our focus allows us to be at the forefront of the field and to help our clients pass their product through the testing and regulatory process in a rapid and cost-effective manner allowing them to market their drug and devices faster.

At WorkSure, quality is a state of mind. Our Quality Assurance program is designed to ensure that your studies are performed in compliance with requirements, guidelines and local regulatory laws.

WorkSure Expertise

With a track record working with industry leaders, mid-size and start–up companies, WorkSure supports its client’s in preclinical and clinical research projects with a wide range of specialized study services. From bench-formulation and research through to phase IV studies and marketing surveys, our experienced staff have an excellent knowledge and know-how of each step of the drug development as well as a global overview of the whole process. At every stage of our client’s projects we are able to conduct studies that meet their specific needs and objectives. We also provide accurate consulting services at every stage of drug development to help our clients to anticipate and plan for any issues which may arise during the drug development process.

WorkSure Consulting Services

WorkSure MedPharma Consultancy provides the required understanding and experience to guide your new products through the development process. As a partner we help to direct preclinical and clinical drug development, to anticipate and plan for any issues which may arrive, to design and manage drug and device development programs, or to provide strategic study design.

WorkSure Drug Development Process

Before any clinical trial can begin, the researchers must file an Investigational New Drug (IND) application with the FDA. The application includes the results of the preclinical work, the candidate drug’s chemical structure and how it is thought to work in the body, a listing of any side effects and manufacturing information. The IND also provides a detailed clinical trial plan that outlines how, where and by whom the studies will be performed.

The FDA reviews the application to make sure people participating in the clinical trials will not be exposed to unreasonable risks.

Phases of Clinical Trial

Clinical Trial is divided in three phases.

Phase 1 trial the candidate drug is tested in people for the first time. These studies are usually conducted with about 20 to 100 healthy volunteers. The main goal of a Phase 1 trial is to discover if the drug is safe in humans.

Phase 2 trials researchers evaluate the candidate drug’s effectiveness in about 100 to 500 patients with the disease or condition under study, and examine the possible short-term side effects (adverse events) and risks associated with the drug.

Phase 3 trials researchers study the drug candidate in a larger number of patients to generate statistically significant data about safety, efficacy and the overall benefit-risk relationship of the drug. This phase of research is key in determining whether the drug is safe and effective.

Once all three phases of the clinical trials are complete, the sponsoring company analyzes all the data. If the findings demonstrate that the experimental medicine is both safe and effective, the company files a New Drug Application (NDA) with the FDA requesting approval to market the drug.

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™ MedPharma Consultancy (WMC), a first medical affairs services 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.

Medical writing

Medical Affairs Role in Pharmaceutical Companies

The Medical affairs groups are a growing vital sector in today’s bio pharmaceutical industry in providing hospital consultants, key opinion leaders (KOL’s), regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of the products.

Medical affairs personnel strive for the highest scientific integrity so as to produce successful clinical trials and supply the greatest support for the market. Medical affairs groups perform many activities often overlapping with sales, Medical marketing, clinical growth, and customer service.

Sales groups may be ill-positioned to accurately present the new product to physicians and quite often need help in making more expert presentations. Medical affairs groups might help in developing appropriate positioning for new releases and help to leveraging the newer indications to come.

Pharmaceutical companies spend tremendous resources for development of new drug treatments. A great deal of time is spent in doing research on potential health-related products and medicines.

While considering the distinctions between post marketing scientific tests and clinical registration demos, medical affairs can fill the requirement for the studies done post approval.

Medical Affairs Role in Functional Areas:
Medical Affairs acts as the central focal point for different therapeutic areas of sales, marketing and research. Medical Affairs work closely with various functional departments such as:

Medical Writing

Scientific Development and Reviewing connected with Product profiles, monographs, package deal insert/ patient information booklet, pharmacology and toxicology parts of registration dossiers with constant updates.

Preparation of Professional medical Development Plan
Providing therapeutic and scientific content for development of study standard protocol
Designing and implementation connected with pharmacoeconomic studies

Reviewing along with approval of regulatory submission, manuscripts, abstracts, posters as well as other scientific documents.

Medical Monitoring:
Medical affairs are the Primary medical contact towards the sponsor, investigative website, and project group.
Medical Affairs supports the look, conduct and evaluation of clinical research and involves continuous data maintenance as well as management.
Involves in talk on study feasibility together with Key Opinion Leaders as well as other potential investigators with regards to possible logistical requirements of the study protocol as well as responds to subject eligibility and disengagement questions.

A Medical affairs team is usually responsible for Medical Monitoring:
Medical affairs are the Primary medical contact towards the sponsor, investigative website, and project group.
Medical Affairs supports the look, conduct and evaluation of clinical research and involves continuous data maintenance as well as management.
Involves in talk on study feasibility together with Key Opinion Leaders as well as other potential investigators with regards to possible logistical requirements of the study protocol as well as responds to subject eligibility and disengagement questions.
A Medical affairs team is usually responsible for clinical trials Protocol and study linked training for researchers and site personnel.

Medico Marketing:

During Pre launch cycle of drug the actual Medical Affairs team will establish a KOL strategy for this product based upon prescriber’s interest in research and education for your given indication. Then MA departments will target prospective KOLs and connect to them regarding the actual science behind the revolutionary product, ongoing trials like the balanced information regarding both positive along with negative results. Also discuss the important thing data from healthcare meetings and summaries of changes to apply the guidelines. In addition it will conduct additional education activities of Sales/Marketing individuals to raise awareness of the disease state, current therapeutics, and current gaps in sufferer care. Further, the interests of the KOLs will be assessed during discussions to find out the appropriate scientific exchange and any prospective opportunities for potential investigator-initiated trials (IITs).
At the time of product launch MA was responsible in ensuring clear understanding on utilization of the product by the prescribers. They exchange technological information regarding compound-specific characteristics and physician perceptions of the drug profile. In those times MA will perform an evaluation of IIT proposals that might generate a Step IV strategy which will further differentiate the merchandise post-marketing.

During the Post-launch period of a drug, MA seeks suggestions from KOLs and along with this, it resolves the queries regarding the product ensuring that they know exactly how you can use the product or service. MA maintains the collection of information regarding the acceptance of the product among prescribers along with issues being confronted by the drug. These valuable data will update marketing work as deemed necessary. Further discussions upon clinical practice roles and potential extra indications with KOL’s facilitate the commencement regarding IITs and Step IV studies.

Conclusion:

Medical Affairs is the majority of credible link with external stakeholders and also play a progressively more important role in communicating the product or service value message to physicians in an objective and ethical manner. They provide assistance in dissemination of technological information regarding current products to regulating agencies and healthcare professionals. Thus Medical Affairs play an important role in establishing appropriate positioning for new items and help to help leverage the newer indications in the future.

ESSENTIALS OF MEDICAL WRITING

Professional medical writing involves communication of clinical and scientific data in the form of research and regulatory paperwork, articles for publication, in addition to content development for health-related publications, pharmaceutical companies and professional medical websites. The nature of medical writing varies using the need of the end user; for example documents regarding medical journals, physicians, individuals, pharmaceutical companies etc.

A capable Medical Writer must have good understanding of life science, medical and pharmaceutical terms along with proper knowledge of The english language. Qualities of a simple yet effective Medical Writer comprise of correct interpretation of target audience needs, better perception of project objectives, ability to prepare thoughts and deliver inside stringent timelines.

Medical writing gets started with appropriate literature seek and identification of reliable cause of information. In order to develop and frame an original work it truly is obligatory to apprehend the topic well by thorough literature review. Moreover, fact presentation in any scientific article is justified judging by genuine references, which makes literature search much more important.

Literature search ends up by having an unorganized pile of raw material which should be shaped and constructed in a order. There must be cohesion among sentences those must grow and count on each other, thus building logically correlated paragraphs. Such glued paragraphs are designed for conveying the medical author ideas effectively, whereas any non-cohesive mass of sentences leaves the reader mixed up and frustrated. The principle of cohesion with medical writing is that the sentences must provide linear move of information making file appealing and interesting for you to reader.

A careful selection in addition to elimination of data in addition to information from collected material is essential. A good medical writer should not stray from the subject. Content must be educational, well-constructed and correlated to hold the reader curious all through. A skillful assemblage of facts is necessary to guide the reader over the write up from what he knows as to the he wants to know in accordance to his needs in addition to expectations.

Medical Writer must allow you to assembling the draft inside a proper format, with apparent and precise explanation shown without ambiguity. Once a draft is prepared it truly is revised repeatedly to make it more comprehensible, communicative in addition to revealing. Medical writer should be capable of comprehend the prerequisites of varied types of articles one example is research article, original post, systematic review, brief record, editorial, case reports, in addition to letter to editor. Along with manuscript preparation, an effective Medical Writer should develop the skills to ascertain the high quality (based upon factors like impact factor and different indexes or rankings) and choice of journals. A clear check out of journal specific requirements is equally important. On top of that, medical writing includes prep of write ups regarding conferences; promotional items for marketing and sales team and training material.

Other attributes of your competent Medical Writer include presentation in the data in accordance for you to client’s requirement or predefined SOPs and most crucial of all is usually to avert plagiarism.
There is a significant need for efficient Medical Writers in drug companies, biotech organizations, nursing homes, contract research organizations (CROs) as well as other health communication agencies. The particular ever changing world of clinical and scientific study demands continuous propagation of technical knowledge. Medical writing is a compelling demand of contemporary scientific world.

WorkSure™ provides a wide range of high quality Medical Writing Services for pharmaceutical, biotech and medical devices companies. Our team of qualified and experienced medical writers helps you bring out a wide range of regulatory, clinical, scientific and marketing communication documents allowing you to focus on your core competency areas.

Investigational Medicinal Product Dossier

Clinical Trial Authorization is essential to conduct clinical trials with humans. CTA can only be obtained after submission of several grouped scientific documents such as Investigational Medicinal Product Dossier (IMPD). EU Clinical Trials Directive 2001/20/EC specifies “investigational medicinal product” (IMP) because, “A pharmaceutical form of an engaged substance or placebo being tested or used as being a reference in a clinical trial, including products already with the marketing authorization but used or maybe assembled (formulated or packaged) in a way different from the authorized type, or when used for a good unauthorized indication, or when utilized to gain further information about the particular authorized form”. IMPD is prepared for obtaining CTA a great IMP and its use from the clinical trial, including information in relation to reference products and placebos. Besides this, data from nonclinical studies in addition to previous evidences of clinical use of IMP is required in IMPD if such information is absent, justification for your same should be provided from the application. IMPD can be connected with two types: a full IMPD plus a simplified IMPD.

A full IMPD is needed if no prior submission of any info on the chemical or biological product was designed to the competent authority and in cases when information cannot be cross referred. A full IMPD really should incorporate summaries of information with regards to quality, manufacture and control of the IMP along with non-clinical in addition to clinical data including animal pharmacology in addition to toxicology studies, previous reports of clinical trial and human experiences using the product, overall risk and gain assessment. Generally, the dossier must not be a large document, even even though exceptions may occur. Data should be presented in tabular form as well as a brief description highlighting the critical points.

A simplified IMPD is ample if all necessary information related to the IMP has been previously examined during a marketing authorization (MA) in any country or during clinical trial application (CTA) on the concerned Competent Authority. The content must include a discussion about the potential risks and benefits of proposed trial. Summary of product characteristics (SMPC) maybe used as IMPD in situations where IMP has a Marketing Authorization in a EU Member State and is being used in the same type, for the same indication with a dosing regimen covered with the SMPC.

As per “Checklist for purposes for grant of approval of various categories of New Drug, Global Clinical trial and Bio equivalence review for export purpose” by CDSCO (Central Drugs Standard Control Organization), the IMPD is critical for “Application of Global Medical Trial” in India.

Medical Communications is crucial for improving clinical care

Medical communication is the process of sharing medical education between pharmaceutical companies, physicians and other healthcare professionals. It plays a vital role in raising awareness of medicines. Medical communication is essentially carried out by medical communication agencies. Medical communications agencies are also referred to as medical education agency or ‘MedComms’ agency.

WorkSureTM, a medical communications agency, offer expert consultancy services to the pharmaceutical companies by suggesting measures for dissemination of clinical data, providing guidance on how to educate their customers about new therapies and organizing campaigns for drug promotion. Medical communications also help to devise risk management strategy (REMS/RMPs) for a pharmaceutical company. Medical communication agencies are contacted by pharmaceutical companies for preparation of documents like Summary of Product Characteristics (SmPC), package insert, patient information leaflet (PIL) etc. Physicians get complete information about the products with the help of these documents. Furthermore WorkSureTM also assist in preparation of a wide range of scientific documents like journal manuscripts for peer review, slide kits, posters and presentations for conferences.

Communication failure is one of the major reasons responsible for adverse clinical events and consequent claims of negligence. The role of medical communication is therefore crucial for best clinical care of patients. Nowadays, medical communication is practiced highly in medical institutions and health research centres. Doctors can also play a major part by sharing important with colleagues, nurses, and other staff in the hospital and share information. WorkSureTM is running FMRC programme to promote medical research and communication in the country. We also do other educational programmes on Medical/Clinical research methodologies

Medico-Marketing shall avoid misleading advertisements and disease mongering

Medico-marketing will involve promotion connected with drug items. It facilitates to help consistently update medical doctors, healthcare professionals and also pharmacists regarding the effective and safe use of medications. Medico marketing involves things to do by simply medicos as well as companies to help actualize promotes for drug care.

The globe Health Organization specifies drug promotion since “all data and also influential things to do implemented by simply drug manufacturers and also marketers, wanting to influence your prescription, supply, obtain, and/or use of professional medical drugs”.

The achievement connected with medico marketing is dependent upon your solutions as well as plans followed for marketing. A simple yet effective marketing administration is dependent upon formulation connected with aims, id of the target audience, having a approach to achieve the objective and also analysis connected with online strategy at frequent time intervals for evaluating your progress.

Pharmaceutical drug companies utilize a pair of streams connected with marketing approaches: 1) press steady stream and also 2) move steady stream. Thrust steady stream strategy aspires to help influence determination maker’s (physician’s) prescription conduct through promotional stuff like describing, drug trying, log posts, log promoting, conventions, professional medical conferences for example. Yank steady stream strategy is actually focused at a time consumers and also pressurizes medical doctors to help suggest a unique drug determined by patient’s ask.

Commercials are essential for comprehending information on medications to help medical doctors and are also popular by simply drug companies for promotion in their items. Facts supplied with advertisements must be connected with premium quality and also should not be incorrect as well as do not forget that. Commercials which usually exaggerate some great benefits of medications and also tend to perform decrease threat associated with prescription drugs, may lead to possible negative effects. Physicians following this kind of promotional data might endanger living in the affected individuals by simply prescribing irrational prescription drugs. Thus, drug companies need to steer clear of unethical medico marketing practices such as inaccurate advertisements and also disease mongering.

The medico marketing section connected with almost any drug firm need to adhere to several major limitations:
1) The global Federation connected with Pharmaceutical drug Manufacturers value connected with drug marketing practices
2) The entire world Wellness Organization’s ethical requirements for therapeutic drug promotion
3) The value served by Wellness Action International

WorkSureTM concentrates on Medico-marketing and Medical Affairs Management also relationships Managing and also assist marketplace in direction of ethical solution promotion.

Risk Evaluation and Mitigation Strategies and Risk Management Plan part II

Risk Management Plan part I
Document important for the submission of REMS contain patient package insert, communication prepare, elements to assure safe make use of, (ETASU) implementation system if ETSAU included, timetable for submission of review. EU- Risk Management Plan consists of three important elements – a. safety information of the item known through studies, b. pharmacovigilance plan which details about handling of uncertainities c. Risk minimization plan which indicates measures that will probably be taken to reduce the consistency of known risks.

Each drug with Risk evaluation and management strategies is listed within the specific database of the regulatory for monitoring end-to-end program execution. Validation of registry with scientific data (patient, physician, hospital, and pharmacy data) is vital for risk monitoring and assessment of program effectiveness with the patient and provider.

The EUROPEAN UNION RMP is more comprehensive, more extensive and contains wider scope than the US REMS on account of binding on a large list of medicines. The US REMS is compulsory for many medicines only, and can be limited by two years post product launch but also in EU the sponsor is obliged to follow throughout the lifecycle of new drugs or biologics.