All posts by WorkSure

Medical Affairs drives new product launch with balance of science

A successful drug discovery and development in the pharmaceutical industry is a long, expensive and complicated process. The product development model included 2 main pillars: an R & D organization for drug manufacturing and commercial organization for marketing and selling of product. Thus, Medical Affairs has become more complex, moreover a separate medical organization that works on product launch activities and has both the scientific and clinical expertise for product commercialization.

Launching a new pharmaceutical product to market is a unique process based on great amount of research work in drug chemistry, manufacturing, controls, pre-clinical science and clinical trials. Medical Affairs play an important role in coordinating internal /company stakeholders (including commercial, market access, regulatory, clinical development and drug safety) which fulfill the requirements of external stakeholders. It caters to pharmaceutical, medical device, cosmetic and complementary medicine industries. Medical Affairs function need to be coordinated in today’s competitive and regulated marketplace and set of activities for product launch divided into following time frames; early market, pre-launch, launch and post launch.

Early market includes time period greater than 24 months prior to launch and it also includes market planning. Pre-launch includes activities from educating department members, customer questions are addressed. During the launch period, Medical Affairs ensure that physicians have a clear and complete understanding of the use of drug including its safety, efficacy, dosing and administration. During the post launch period, Medical Affairs make sure that prescriber inquiries are answered and they provide informational services to healthcare centers. The activities can be divided into three broad categories: Medical Communication and Publications, Medical Science Liaisons (MSLs), Medical Information services.

Medical communication team needs to communicate data in a medical affair group that directs all drug-related publications such as abstracts, posters and manuscripts to support commercial products. Another key role for medical communication team is developing data in an accurate, complete and unbiased way to deliver maximum value to a company. A publication plan must be carefully coordinated before they are made available to serve the public health. Medical science Liaisons (MSLs) plays an important role in the success of a company. The first responsibility of an MSL is to maintain peer-to-peer relationships with leading doctors who influences other doctor’s and physicians. These influential doctors are referred as Key Opinion leaders (KOLs). KOLs are an extremely valuable & necessary component for markets and medical staff throughout the life-cycle process of a specific drug or product. At the time of launch, medical information services including the medical staff responds to question about the commercial drug products.

WorkSure™ Medical Affairs organization mission is to provide the consulting services to sales & marketing, clinical trials, pharmacovigilance, regulatory and legal departments. We at WorkSure are proactive at all levels, identify novel approaches and establish dedicated boundary-spanning teams for different companies. We work at all stages in the life cycle of a biopharmaceutical product/device which is paramount for a successful, timely and cost efficient drug development process. The various Medical Affairs functions that we offer are: Medical strategy and business support, Medico-marketing launch collaterals, Medical Communication/Publications, KOL management & interfacing responsibilities, Medical Education & training. Medical education activities include CMEs, seminars, small group meetings, updates and conferences etc. We create and deliver effective and successful training programs for clinical, scientific, marketing and sales personnel.
WorkSure, Medical Information System Management Software provides highest quality communication that flows from medical & marketing via other stakeholders & comes back to them as information. This provides key support for a product as it enters the marketplace and transitions through the product lifecycle.

Clinical Data Management : A multidisciplinary endeavor tool

Clinical data management (CDM) encompasses the entry, verification, validation and quality control of data gathered during the conduct of clinical trial. This helps to produce a drastic reduction in time from drug development to marketing. CDM is a critical phase in clinical research which leads to generation of absolutely accurate and statistically sound data from clinical trials.

Two such standards created by the clinical data Interchange Standards Consortium (CDISC) are particularly vital to Clinical data management: the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) and the Clinical Data Acquisition Standards Harmonization (CDASH). The former is currently mandated for use by the U.S. food and drug Administration (FDA). The latter created a standard format for collecting data across studies so that data submissions can be more easily traced and reviewed. Members of clinical data management team (CDM) are actively involved in all stages of clinical trial right from inception to completion.

Case report form (CRF) is a specialized document for collection of patient’s data in a clinical trial. CRF is a paper or electronic questionnaire. Clinical Data Management System is widely used to manage the data that is collected as part of a formal clinical trial programme. Data obtained from the investigator site in the CRF is stored in the CDMS. CDMS also performs coding of data and employs various means to verify the data to reduce possibility of error due to human entry. Once the data are uploaded by site then data validation is done by data validation team if there is any discrepancy then alert is send to the site to resolve it.

Similarly, CDMS is a tool for capturing and delivering accurate ongoing patient care data. Collection of ongoing assessment data includes past health of patient as well as current/present problems of patient, its treatment plan and therapeutics. All hospital or clinic based data can also be captured and regular clinical practice analytics can be obtained.

Medical coding or Medical classification is the transformation of narrative descriptions of diseases, injuries and healthcare procedures into numeric or alphanumeric designations (that is, code numbers). The diagnoses and procedures are usually taken from a variety of sources within the health care records, such as the transcription of the physician’s notes, laboratory results, radiologic results. The dictionaries used for adverse events: MedDRA (Medical Dictionary for Regulatory Activities) and for medications: WHO-DD (World Health Organization Drug Dictionary).

Validation of data is the process of checking database. Data should be clean, accurate and in a standard format for overall study. Quality should be maintained for overall study by performing quality checks at intervals for all data points prior to database lock. Database lock for a study is done to ensure no manipulation of study data during the final analysis. Database lock for a study is done once all data management activities are completed. Organization of data ensures collected material is accepted in the scientific community.

The ultimate goal of CDM is to assure valid and correct data support conclusions from research. Achieving this goal protects public health and confidence in marketed therapeutics. WorkSure has developed its own 21 CFR compliant CDMS which can be used both for Clinical trials and Hospital/clinics patient data collection and management. Our simple and easy to use CDMS even help complex data collection, with an added advantage of competitive cost.

Med-Digital Marketing can address the challenges in all paradigms of healthcare

Digital is a crucial part of everyday life. Digital marketing is an online or web marketing for the promotion and sale of goods. Medico-Healthcare digital marketing involves use of IT digital tools & strategies for promotion and sales of products related to Pharma/Biotech/Medical device/Nutraceutical industry.

Digital marketing is equally effective in addressing both the paradigm of healthcare that is doctors as well as patients. With the help of digital discoveries, the outcomes of treatment in patients has fairly improved. Healthcare information search is one of the most common online activities among internet users of all ages. Electronic gadgets like mobiles and laptops are vehicle of digital marketing which provides updated information on a specific topic. Some researchers have found that 72% of patients use internet to search for information on hospitals, doctors & they search for the disease and drugs & other health related issues. Apart from single way of communication, IT tools now act as listening posts for customer feedback also.

Digital Healthcare is the intersection between two huge sectors life sciences & healthcare technology.  Most of the Life sciences & healthcare technology companies plan to increase their investments in digital healthcare to improve the sales of pharmaceutical products. Conventional marketing tools such as product brochures, catalogs, visual aids can be adapted and reproduced easily in digital interactive format for better understanding. This can happen both with and without physical presence of company representative. The distant marketing is beneficial for the audience to get the fruitful information without taking any physical appointment to the doctors; and doctors also can read and comment on this in their leisure time.

Digital Marketing in healthcare industries has raised new marketing avenues and provides an independency to do such activities in innovative ways. The physicians also have more interest to read the information in the digital channels because they have busy schedules & don’t have much time for medical representation. Physicians prefer to conduct easy tasks like information checking on mobile. Pharmaceutical companies are offering clinician’s online customer service portals, live video presentation to connect with patients easily.

Medical digital Marketing plays an important role in all over business strategy & going to change the world by affecting all business & mode of life. To have an effective content marketing strategy, healthcare companies must have a comprehensive, written plan for success. Different elements in society are now taking an advantage of digital technology to create beneficial relationship.

Digitization in medical & healthcare marketing has raised new opportunities & provides freedom to do innovative activities. Organizations have to follow promotional guidelines & code given by iFPMA, WHO & OPPI to maintain the sacredness of the information.

There are some benefits of medical digital marketing in pharma/biotech/medical device/nutraceutical industry

  • Improve the reputation of professionals
  • Increase patient engagement
  • Improve patients experience
  • Increase brand awareness
  • Increase patient retention
  • Improve brand perception
  • Less time consuming
  • Reasonable prices
  • Can find customer globally
  • Easier to get the right audience

The medical & Pharma industry is competitive & more patients have gained by being more active on social media. Today’s digital generation demands, a customized & precise marketing strategy, physicians need to update themselves possibly by digital education programs like turning online to resources for continuous medical education (CME), retrieving patient education materials, viewing guidelines etc.

The development of miniaturized IT devices such as smartphones & tabs, healthcare providers (hospitals, Pharmaceuticals companies and device companies) spread & promote the desired messages & Information to the patients located at remote places.

WorkSure® is leader in Med-Digital Marketing which helps in developing knowledge based scientific platform for healthcare professionals and healthcare industries. WorkSure® provides the Product Promotion Platform, Medical Information System Software, KOL interaction digital platform and clinical education management software for HCPs & industries.

Health Economic Outcome Research: An aid to better therapeutic decision making

Health economic and outcome research (HEOR) consist of pharmacoeconomic research and health technology assessment activities. HEOR provides evidence based justifications and profitable value of healthcare interventions and therapies. HEOR supports health care authorities to understand the impact of therapies and treatment options. HEOR plays a vital role in internal decision making process and deliver useful information for licensing and R&D, as well as pricing and market strategies. It also helps to define reimbursement with existing and newly introduced medical technologies.

The cost and demand of healthcare is increasing day by day due to increased technology, standard of living, life expectancy and increased demand in heathcare quality and services. High pricing of medicines and limited resources facilitates the need of Pharmacoeconomics. It reduces spending of resources without any competitive benefits at all the stages in the development of medicines i,e when they are researched, produced, and marketed. It supports clinical pharmacologists in promoting rational prescribing as well evaluates perspective, time horizon and cost.

Pharmacoeconomic evaluations are stepwise starting from problem identification and determination of study perspective to find out the specific treatment options, thereby selecting appropriate model. It measures input and output of investment, identify the resources necessary to conduct the analysis and establish the possibilities for the outcomes to the alternative. It also designs a decision tree, conducts analysis and present the result to acknowledge any assumption. The methods involved in pharmacoeconomics helps in interpreting issues related to cost & health benefits and weigh the cost of alternative drugs against the outcomes and policies.

Health technology assessment (HTA) is an evaluation of effects and impacts of health technology systematically. Its a multidisciplinary art to measure the socio-economic, organizational and ethical issues. HTA evaluates evidence of safety, effectiveness of real world and cost, patient reported outcomes as well as social, legal, ethical, and political impact and also long term consequences of a health care technology. The main objective of conducting an assessment is to inform a policy in decision making. Recently a reference document on HTA has been developed by World Health Organization which details about the concept and various support programmes of HTA.

Health economic and outcomes research acts as an important tool to support clinical decisions, individual patient treatment, formulary management, contribution to medication policies, resource allocation. HEOR supports drug inclusion or exclusion to the formulary for a cost effective treatment. Economic modeling and techniques of pharmacoeconomics supports the treatment of patient and analyze them by means of cost minimization analysis, cost effectiveness analysis, cost benefit analysis and cost utility analysis.

At WorkSure® we provide clear, quantifiable, and prescriptive methodology to decide among alternative outcomes in clinical decision analysis through its economic modeling capabilities. We recognize, measures, and relate the costs and consequences of drug therapy to healthcare systems and provide well trained, highly experienced team of economists, medical professionals and biostatisticians. We are highly specialized in Pharmacoeconomics studies, modelling in health care budget analyses. We have successfully completed Pharmacoeconomics projects for various healthcare institutions to optimize their resources and activities accordingly. We relates patients, society, and economy to drug therapy. We establish guidelines or standards of practice, creates a cadre of trained producers and consumers of Pharmacoeconomics work. We provide education on the relevant features of this discipline for practitioners, private sector executives and to government officials.

Medical digital marketing: bridging the gap between care providers and end users

Medico or healthcare digital marketing involves use of IT and digital tools and strategies for promotion and sales of products related to pharma/medical/ biotech industry. Apart from direct product promotion, digital marketing can be used effectively to build a brand or establish an entirely new therapy segment.

With rapid digitization and internet reach over last decade, the conventional marketing strategies no longer provide the quintessential edge to their clients. Although healthcare is slow to embrace the digital marketing, it is fast catching up with other sectors which depend heavily on sales and marketing.

Digital marketing is equally effective in addressing both the paradigms of healthcare i.e. doctors and patients. Whether there is a question of providing recent updates to single physician practices using customized digital content on iPADs or running a mass patient education campaign, software tools can handle myriad of tasks. Mass mailers with targeted messaging and subtle branding are now routinely being used to spread the massage among larger audience.

Conventional marketing tools such as product brochures, catalogs and visual aids can now easily be adapted and reproduced in the digital format. These are then circulated to the desired audience instantly without the need for taking a formal physical appointment for providing information to the doctors. Providing sponsored updates on regular basis on any therapeutic area or relevant topic is also a useful marketing strategy. This can be easily accomplished using various digital channels such as newsletters, mass mailers and online blogs.
Apart from the one-way communication, IT tools now act as listening posts for customer feedback. Although, this does not strictly fall under the ambit of marketing, yet collection and analysis of customer feedback (hospitals/physicians and patients) is an important function of after sales activities. This may be particularly of interests for medical device manufacturers.

With the advent of miniaturized IT devices such as smart phones and tabs, healthcare providers (pharma/hospitals and device companies) can propagate the desired message to patients located at remote places. Specialized apps or applications which double-up as marketing tools, are increasingly being used for promoting the product. Mind boggling spread of internet has fueled social media growth over last few years. Needless to say that social media has further helped to bridge the ever decreasing gap between care providers and end users. Pharma companies can now run social media campaigns to build product awareness among the medical fraternity. Large amount of relevant messaging can simply be uploaded on these sites which can be viewed by the concerned stake holder at their convenience.

Digitalization in healthcare marketing has opened new marketing avenues and provided freedom to do such activities in innovative ways. However, with freedom comes great responsibility. To ensure this, digital marketing is governed with laws and ethics. Organizations have to follow the promotional guidelines and codes given by iFPMA and WHO to maintain sanctity of information.

WorkSure® is a leader in Med-Digital marketing with strong medical domain and best IT infrastructure. We develop and define strategies to improve the visibility and reach of the product, provide guidance in KOL management and scientific activities. Our on demand or full time engagement models provide flexible approach of client association. This enables us to cater to wide gamut of healthcare providers that include pharmaceutical/medical device companies, academic institutions or hospitals.

Med-Digital solution is shaping the future for pharmaceutical marketing

‘Digital’ has become an important part of the everyday life. Digital healthcare plays a key role in the overall business strategy, and is going to change the world dramatically, affecting all businesses and modes of life. The fastest pace of technological and medical advancement, increase in healthcare spending and the needs of a growing and aging global population makes it a major sector in its own right. Most of the life sciences and technology companies plan to increase their investment in digital healthcare.

Digital healthcare is the intersection between two giant sectors- life sciences and technology. Healthcare information search is one of the most common online activities among internet users of all ages. Pew Research found 72% of patients use internet to search for information on hospitals, doctors and medical treatments. The presence of interactive digital communications is necessary in order for the pharmaceutical companies and Health service providers to ensure full relevance and profitability. The web and mobile technologies have the potential to both deliver personalized and culturally-tailored communications that are widely used and highly-trusted by consumers. Various digital platforms are linking online professional and patient communities and helping them adapt to increase usage of mobile, social media for medical information.

Physicians prefer to conduct easy tasks such as information-checking on mobile devices, while leaving more complex activities like CME for completion on their PCs. But improvement in mobile browsing capabilities and introduction of IPADs, tablets, smart phones etc. physicians have started using them for more advanced activities than just reference purposes. Physicians are no longer limited to in-person details for information and updates on pharmaceutical products, but can easily seek out this type of information at any time through various medical information digital platforms. In light of this, pharmaceutical companies are also offering clinician online customer services such as customer service portals, live video presentation, interactive detailing and e-sampling. Sales team is also “digitalizing” its in-person visits with tools such as tablet PCs, IPADS etc.

To have an effective content marketing strategy, healthcare companies must have a comprehensive, written plan for success. There are some businesses that are very innovative in terms of digital advancement, but lack of good case studies of digitalisation in the pharmaceutical sector limits the use. Some organisations are trying to understand the true value of digital while others are integrating it into the wider marketing strategy. Despite these barriers, healthcare marketing cannot be overlooked.

The traditional one way relationship in healthcare system will change to two way relationship exclusively with help of digitalization on this sector. Digital Marketing in any sector is a more cost-effective and less time consuming method to communicate with customers compared to traditional marketing. Digital marketing allows pharmaceutical marketers to use data to create more strategic engagement with prescribers and physicians.

WorkSure® is a Med-Digital solution provider and work as Medical knowledge and technology partner to all healthcare industries. WorkSure® brings in a unique capability of world class Medical services along with IT infrastructure, and is involved in developing various interactive digital platforms for doctors and patient education. WorkSure® IT based products helps improve qualitative healthcare, while managing large databases for doctors and patients to have easy and quick interactions. Various digital interaction platforms and medical information transfer systems help easy flow of information for industry, physicians as well as patients.

Knowledge about medico legal issues for a treating doctor: Mandatory social responsibility

The right to healthcare requires ensuring that appropriate physical health services are available without discrimination and are accessible, acceptable and of good quality. Medico legal case (MLC) is a case where besides the medical treatment; police investigations are essential to fix the responsibility regarding the present condition of the patient. MLCs are cases of trauma, ailment or infection where the attending doctors require legal knowledge and shall understand the right to healthcare of patient. Cases of accidental deaths, dead on arrival, unnatural events, fire arm injuries; mental illness, physical injuries and poisoning under suspicious circumstances are some examples of MLCs.

MLCs are an integral part of medical practice that is frequently encountered by medical officers, causality medical officer, in-charge ward. The decision to label a case as MLC should be based on sound professional judgment after taking a detailed history and thorough clinical examination. Case of discharge / transfer/ death under suspicious circumstances must be reported to the police & nearest of kin whenever such MLCs are brought to the notice of attending doctor for treatment. Also, police should be informed immediately by the Medical officer on sudden death of the patient after admission to the hospital especially when the cause of the death is not known.

Legal formalities restraints of the institutions or hospital shall not stop them from providing basic medical treatment. The treating doctors shall have point to point knowledge of medicines related MLCs and even law of the state and country. There are various types of medico legal cases registered against medical professionals which include failure to preserve the necessary samples for subsequent examination, releasing the dead body of a patient in a criminal case without inquest and Post- Mortem or carelessness/negligence towards the patient. Generally legal problems start with controversy revolving around the duties and rights of doctors. The healthcare professionals, allied themes and the lawyers are engaged collectively in legal advocacy to ensure the protocols and procedures utilized at health.

There are differences in the legal procedures being followed by different states. In non­-entitled cases, after the initial stabilization, the patient may be transferred to the nearest hospital and by ambulance. To realize the right to healthcare of survivors, health professionals must be trained to respond appropriately to their needs, dignity and autonomy of each survivor.

Law is common to all; knowledge about medico legal issues is not optional for a treating doctor but a mandatory social responsibility. It is important to handle such cases to facilitate social and legal justice. A doctor has a right to refer the patient to other facility to maintain regularity of the treatment if required. In addition, he/she also has the right to turn away before commencing medical treatment. But it is necessary to provide basic minimum care to the patient when some emergency occurs and he/she can also ask for written refusal letter if the patient does not want follow what has been advised.

Doctors should register MLCs whenever they are in doubt to determine the medico legal implications. He/she should maintain the complete records of the patients including the personal details, history, examination and treatment of the MLC patient. It is advisable to follow the legal aspects to avoid embarrassment in the court of law due to the lack of knowledge and awareness regarding MLCs and their practices.

WorkSure® offers MLC products to help medical fraternity through increasing awareness. The products continuously helps the doctors, lawyers & private nursing home by providing reader friendly information about the commonly encountered situations within medical legal domain. We also provide valuable guidance to protect you from all the medico legal complications in day to day clinical practice.

Med-Digital initiatives are now serving as knowledge reservoirs of education for healthcare

The phenomenal change of the digital world during the last few decades has revamped the thinking and learning capability drastically. Healthcare system is adequately influenced by digitalisation and thereby prompting a need to change traditional patient education based on paper and vocal methodology to an active audio-visual digital system. Although, conventional tactics such as conferences and face-to-face details are still important tools when marketing of devices and drugs are concerned. In this era of digitalization, physicians need to update themselves, possibly by digital education programs like turning online to resources for continuous medical education (CME), retrieving patient education materials, viewing guidelines etc.

The Internet has been a key factor in driving globalization in recent years. It provides easy convenience to learn, update, and communicate among patients, families, and health providers. Digital platforms can also evaluate the impact of internet-based programs on health events, promotion, and consumer fulfilment. With the help of digital discoveries, the treatment outcome in patients has fairly improved..

Besides e-services, telehealth has also increased practice alternative for providers. Telehealth encompasses a broad variety of technologies and tactics to deliver virtual medical, health, and education services. Telehealth is now more commonly used as it describes the wide range of diagnosis and management, education, and other related fields of healthccare. These include, dentistry, counselling, physical and occupational therapy, home health, chronic disease monitoring and management, disaster management and consumer and professional education.

One of centered digi platform, YouTube is found to offer many advantages over self-publication, mainly in terms of scientific simplification, increased audience attraction, identitibility, and analysis. In context to the transitory awareness seen in most YouTube content, the channel is gaining non-stop popularity. YouTube’s broadcast mock-up distributed aspects of the connection between educators and their learners, thereby restrictive its use for more purposeful activities, such as to continuing patient medical education.

The National Health Services (NHS) Commissioning Board, in 2013, launches its new integrated customer service policy. According to the new service utilises which include the full range of channels like web, telephone, apps etc to offer access to information to support precision, involvement and communication. Digital health services have verified benefits in informed choice, shared result making and patient contribution.

Also patient education has an important role to play in management of chronic health. Many recent studies, in patients with multiple chronic diseases, demonstrated that efficient patient education can result in improved clinical outcomes and also minimise the utility of critical medical care services. Computer based education plans have been shown to improve disease-specific information which also helps in self-management. Increasing patient curiosity in using computing, development of technical capabilities of Personal Digital Assistants (PDA), effectively provide a possibly attractive tool for patient education. PDA is now getting a high class acceptance for both patients and clinicians as an interactive patient-education tool.

Different elements in society are now taking an advantage of digital technology to craft beneficial relationship. Each and every element in the multifaceted system of health care and medical guidance can thus be easily connected, and involve the patient in the heart of care and the trainee’s in progress relationship to the patients to focus them on education.

WorkSure® is a Med-Digital Marketing company who work as Medical knowledge and technology partner to all healthcare industries. WorkSure® brings in a unique capability of world class Medical services along with IT infrastructure, and is involved in developing various interactive digital platforms for doctors and patient education. WorkSure® IT based products helps improve qualitative healthcare, while managing large databases for doctors and patients to have easy and quick interactions

Application of Pharmacoeconomics for better informed decisions in Health Care System

Pharmacoeconomics (PE), a sub discipline of health economics, evaluates the behaviour 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. In other words it identifies, compare and measure the cost and value of one pharmaceutical drug or drug therapy to another. In broad term, it teaches the three basic outcomes i.e. clinical, economic, and humanistic to be considered in drug therapy.

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Crf designing : challenging step in clinical data management

According to ICH guidelines for GCP, CRF can be defined as a printed, optical or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject. CRF development is one of the most crucial steps in Clinical trials as it preserve and maintains quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and biostatistician.
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