Medical Service KPO: An offshoot of Healthcare KPO

Knowledge Process Outsourcing (KPO) is a higher-end version of outsourcing business processes that require significant domain expertise. Thus KPO emphasizes on services based on knowledge power. At present, major categories of domain knowledge that are working as KPO include legal process, research and development, market research, financial services research, business intelligence and medical services.

Medical service KPO is a health care KPO, which, identifies and addresses the met and unmet medical needs associated with products, therapies and disease states in order to drive improvement in patient outcomes. It performs highly complex and structured medical/scientific tasks which necessitate analytical and technical skills along with vital judgemental abilities. Services of a medical service KPO include research & medical writing, clinical data management, medical affairs management, medical based marketing & sales support and training. A proficient medical service KPO team comprises of highly qualified (medical postgraduates and PhDs) and skilled workforce with experience and expertise in various therapeutic areas. The team should have high levels of intellectual property and business knowledge sensitivity.

Currently pharmaceutical/biotechnology companies are facing a lot of challenges viz. increasing research & development costs, unavailability of blockbuster molecules, pricing pressures as well as increased overheads. At this juncture, outsourcing of high-end processes to third party is a viable option. The major strength of this approach is not the cost-saving aspect but the more value that these services provide. A medical service KPO not only supports pharmaceutical, biotechnology and medical device industries but also hospitals, CROs and other healthcare sectors. Medical service KPO also assists healthcare fraternity to undertake and publish research projects. Thus they promote medical research at the level of individual physician, as well as hospitals; conduct training in medical research methodologies; assist in developing research plans; managing, analyzing and interpreting data, and even communicating medical research on various platforms and journals.

An early driver of medical service outsourcing is the shortage of skilled manpower. Companies face unavailability of trained and specialized professionals in this knowledge-intensive, high-skill sector of medical support function. Also developing and sustaining an in-house team of highly technical medical professional is costly and drain lot of money and efforts of training. WorksureTM, a first medical service KPO in India, works as medical knowledge partner to various health care industries and even individual physicians. They are a network of highly qualified and experienced academicians, administrators and industry experienced professionals who have come together to provide holistic services for the establishment and operation of medical support function.

Domain expertise, language skills, knowledge of regulatory framework, innovative processes and quick response time have led to efficient service delivery and growth of WorkSureTM as medical service KPO. WorkSureTM understand the importance of training and skill development, especially at the entry level. In addition to project-specific training, it focuses on developing soft skills and behavioural aspects to help the employees become more productive in their work. WorkSureTM, first medical service KPO in India has a vision to promote medical research through model of cost elasticity, provide continuous education and learning opportunities to practising medical fraternities, pharmaceutical/biotech/medical device industries and increase emphasis on ethical medical/promotional communication.

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Pre-clinical and clinical research: Part of drug development process

Preclinical development
Pharmaceutical research plays an essential role in the development of new drug molecules for safe and effective use in patients. Pre-clinical and clinical research is two important phases in drug discovery and development process. It takes about 12 to 16 years to bring a molecule from laboratory to clinical practice. Based on the type of drug molecule, the duration of pre-clinical research varies from 2 to 6 years while clinical research takes approximately 7 to 12 years. Today the challenge with pharmaceutical research is to reduce the lead time of pre-clinical and clinical phases, which can be made possible by adopting newer technologies, using rational drug design process in place of traditional processes.

Pre-clinical research is combination of in vitro, in vivo and ex vivo experiments before the clinical trials. Target identification, target validation, lead identification, lead optimization and finally synthesis of the new drug molecule for a specific disease are important steps of pre-clinical research. After the synthesis of a drug molecule, different tests and experiments are done in laboratory and animal models for the collection of safety and efficacy information for the clinical trials. The primary objective of pre-clinical research is identification of physiological, toxicological and efficacious potential of drug molecule. Study of pharmacodynamics, pharmacokinetics, immunogenicity, immunotoxicity, developmental toxicity, genotoxicity studies and carcinogenicity properties with identification of initial safe dose, target organs and other safety parameters constitute secondary objectives. Regulatory authorities wants to minimise the use of animals in pre-clinical trials due to animal rights issues, so

selection of animals for the pre-clinical trials is another important aspect, normally one rodent and one non-rodent species are used for the same. High quality safety and efficacy data is required by the regulatory authorities before giving approval for conduct of clinical trials in humans in the form of IND (New Drug Application) submission.

Phases of Clinical development
Clinical research determines the safety and efficacy of medications, devices, diagnostic products and treatment regimens discovered for the human use in terms of prevention, treatment, diagnosis or for relieving symptoms of a disease. Successfulness of the pre-clinical research and approval from the regulatory authority are the mandatory requirements for the clinical trials. Clinical trials are divided in 4 phases from phase 1 to 4

Phase 1 clinical trials commonly known as human or clinical Pharmacology trials, first phase of clinical trials conducted in small group of healthy human volunteers (20-100). In this phase the medicinal product is administered first time in human body for identifying pharmacokinetic (absorption, distribution, metabolism, excretion and liberation) properties of drug. The main objective of phase 1 clinical trial is to assess the safety data and safe-dosing range of a drug.

Phase 2 clinical trials commonly known as therapeutic exploratory trials, performed on larger groups (100-300) after the establishment of initial safety of the study drug in Phase 1 clinical trials. The main objective of this phase is to collect the data for effectiveness and safety assessments in patients. Sometimes phase 2 trials are divided into: phase 2a trials and phase 2b trials. Phase 2a trials, commonly known as pilot trials, collect information about pharmacodynamic (dose-response, type of patient, frequency of dosing and find any other issues related to safety and efficacy) properties of drug in patients. Phase 2b trials commonly known as pivotal trials are well-controlled trials to evaluate safety and efficacy in large number of diseased subjects (500-1000), represent the most rigorous demonstration of efficacy.

Phase 3 clinical trials commonly known as therapeutic confirmatory trials usually involves 1,000 to 5,000 patients in multicentric setups. The main objective of this phase is to confirm safety, efficacy and identify adverse events related to drug molecule. Sometimes phase 3 trials are divided in 2 groups: Phase 3a trials and Phase 3b trials. Phase 3a trials are conducted before the new drug application (NDA) submission to the regulatory to generate additional data on safety and efficacy in relatively large numbers of patients in both controlled and uncontrolled trials. Phase 3b trials sometimes called as peri-approval trials are conducted after NDA submission to the regulatory but before the approval of marketing of the drug. Phase 3b trials may supplement earlier trials, complete earlier trials, or may be directed toward new types of trials (e.g. quality of life, marketing) or Phase IV evaluations.

Phase 4 trials commonly known as post-marketing surveillance, takes place after obtaining marketing approval for the drug. Phase IV trials involves the pharmacovigilance and technical support for the patients and medical professionals. The main objective of these trials is to set up, evaluate and collect long-term safety data for the drug in the form of PSUR (periodic safety update report) as a requirement of regulatory authorities.

Apart from these main 4 phases of clinical trials, 2 other phases of clinical trials - phase 0 and phase 5 - have been recently introduced in the field of clinical research, based on type of the drug or molecule. Phase 0 clinical trials are commonly known as micro-dosing trials, a very small dose of investigational drug is given to the healthy voluntears for the study of efficacy, toxicity and pharmacokinetic properties. Phase 5 clinical trials are also a type of post-marketing surveillance to study the comparative effectiveness research in a specific community or populations.

We at worksure provide all the solutions for the pre-clinical and clinical research, in terms of trial related document (Protocol, CRF, Investigator brochure, ICF & other)preparation, editing & review of sponsor prepared documents, investigator meetings & study result meetings arrangements, SOP preparation, developing QA/QC plan, clinical study reports prepration, abstracts and publication writing, poster/PPTs prepration for conferences and meta-analysis/systematic review prepration. We also provide regulatory solutions and clinical data management services for the clinical trials.

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Understanding Pharmacovigilance System & Processes

According to WHO “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” In other words the goal of pharmacovigilance is getting the best outcome of therapy by patient care and surveillance. Good pharmacovigilance will identify the risks and risk factors related to adverse drug reactions (ADRs) during the complete product life cycle. This information allows for intelligent, evidence-based prescription and has the potential for preventing ADRs.

The importance of Pharmacovigilance

The primary aim is to enhance patient safety and to provide reliable and balanced information for the effective use of medicines. The secondary aim is communication of new safety ?ndings to the national and international regulatory authority in a timely manner. Pharmacovigilance programmes promote the education and training in this field and its effective communication to the public. Pharmacovigilance identify adverse events and their rates with the possible risk factors. It assesses causality with respect to clinical relevance, frequency and distribution of ADRs, which helps to understand the benefit, harm, effectiveness and risk of medicines.

Good Pharmacovigilance Practice

The concept of pharmacovigilance is normally not well understood, either by health professionals, patients or the general population. Development of guidelines and standards are required for a coherent and good pharmacovigilance system, which describe the practical details of the intended information Now.

Good pharmacovigilance systems should have the capability for receiving and processing of reports with veri?cation, interpretation and case causality assessment. It should have databases and procedures for data analysis, review and signal detection. An effective coordination between health care settings, regulatory and public health activities is required. Also regular training of health care workers in reporting adverse reactions improves both active and passive reporting.

Spontaneous reporting is a system whereby case reports of adverse drug events are voluntarily submitted by health professionals, pharmaceutical companies or consumers to the national pharmacovigilance centre. It is basically the reporting of a suspected adverse reaction on the initiative of the health professional that becomes aware of the problem, or on the patient’s initiative. Cohort event monitoring refers to the use of prospective, observational cohort studies of patients to whom the medicine of interest has been administered with recording of all adverse events.

Pharmacovigilance system may be run by a person or group of persons with expert knowledge of drug safety and adverse events under the independent government setup. The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health & Family Welfare, Government of India in collaboration with Indian Pharmacopeia commission is initiating a nation-wide pharmacovigilance programme for protecting the health of the patients by assuring drug safety. The programme shall be coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC). The centre will operate under the supervision of a Steering Committee.

We at WorkSure provide complete Pharmacovigilance system and Process solutions for signal detection, signal evaluation, medical review and causality assessment of safety data (AEs, SAEs, SUSARs etc). We also provide medical writing services for preparation of safety reports eg ICSRs, PSURs etc as per regulatory requirements, and resolving queries from regulatory authorities on safety issues.

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Medical Writing

Medical writing, an integral part of medical research and communication, can be defined as an art of creating scientific documents with the aim of transmitting information of technical nature in lucid and simple manner to health care professionals, scientific community, general public and patients. Target audience needs normally define the pattern of medical writing. The language for medical education of Physician/healthcare professional has to be highly technical while simple and lay communications are required to connect with general public or patients. There is a significant need for medical writing in pharmaceutical and biotechnology companies, contract research organizations (CROs) and other health communication agencies. WorkSure™ medical writing team supports an umbrella which includes scientific writing for marketing promotions, sales team training and education, medical education, patient and public education, medical research and regulatory communications. Any writing goes through a stringent medical review process for quality control and to prevent plagiarism.

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Medical Affairs

Medical Affairs identify and address the medical needs associated with products, therapies and disease states thereby driving improvement in patient outcomes in line with commercial objectives. Medical Affairs came into existence in pharmaceutical and biotech industries to aid interactions between health care professionals and company representatives. However with time, the role of Medical Affairs has transformed from being a traditional support function to an equal partner role. Besides providing scientific and medical information to healthcare professionals, key opinion leaders and regulatory bodies, Medical Affairs plays an important role in promoting proper and ethical use of a company’s products and therapies for the benefit of mankind. Thus, Medical Affairs function supplements the work of Research & Development and also enhances sales and marketing efforts. By and large Medical Affairs operates as the medical conscience of the company and contributes to its growth and success. Strengthened regulatory and public scrutiny, growing competition and swelling budget for drug development has made the Medical Affairs role even more crucial to pharmaceutical companies' success. Nevertheless the companies face challenge in managing the Medical department due to high manpower costs.

WorkSure™ Medical Affairs provides 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. The various Medical Affairs functions that we offer are:

Medico- Marketing & business development
The complexity of medical marketing is one of the important aspects of a business proposal in the pharmaceutical industry. Promotion refers to all informational and convincing activities by company and distributors, the effect of which is to bring about the prescription, supply, purchase and/or use of medicinal drugs. Medical Affairs review external communications for ethical and credible promotion of all brands. Across product life cycle, the Medical Affairs provide guidance on therapy positioning in all marketing and promotional campaigns and keep a close watch on the approvals. Medical Affair activities ensure appropriate market conditioning which has a real impact on increasing product awareness.

KOL management & interfacing responsibilities
The Key opinion leader (KOL) management should be aligned with both scientific and commercial perspectives which require optimal organizational structure. Harmonizing KOL activity is increasingly crucial for both compliance and effectiveness. The communication of meaningful information like crafting scientific exchange tools and resources for continued medical education on disease state, current therapeutics, and patient care gaps is the underpinning of ongoing interaction between KOLs and Medical Affairs function.

Clinical research & regulatory activities
Medical Affairs team works closely with the clinical development team for planning and organizing clinical trials. They support clinical development plan, protocol development, investigator selection and meetings, ongoing data maintenance and management, statistical analysis & interpretation, report writing activities etc. They are involved in pharmacovigilance, regulatory support and post marketing safety and surveillance studies. Medical Affairs professionals evaluate and conduct pharmacoeconomic studies to facilitate cost effective health care decision making. The Medical Affairs department plays a central role in strategizing regular audits for checking compliance and quality assurance.
Medical education and training
The role of the Medical Affairs function is to educate health care professionals through the delivery of precise, complete and impartial information that supports a product. External education activities include CMEs, seminars, small group meetings, updates and conferences etc. A sales representative also plays a reasonable role in providing customers i.e. doctors with recent updated information about the products and guidelines. So, sales representatives are also required to be trained to stay abreast with the latest information on the products, and also industry regulations.

Medical communications
Field of medicine is ever-changing with constant flow of new knowledge and information. One of the main responsibilities is supplying the medical profession with the best available information pertaining to their area of interest. Medical writing has established as an important function of Medical Affairs, because it requires specialized knowledge and skills to write scientific documents which are well-structured, and presented in a clear and lucid manner.

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