Medical affairs is a term that describes the department within a pharmaceutical or medical device company that interacts with physicians and other healthcare professionals who utilize or are involved with research related to the company's products. Clinical affairs departments typically handle a wide variety of clinical communications with prescribers, the provision of grants to fund investigators studies, as well as various additional researches and other tasks. Communications overseen by a medical affairs department may include responding to requests for information about off-label usage, publications, safety information, and independent clinical education.
Bringing a new pharmaceutical product to market is a unique process based on a number of requirements for supporting a product launch. For a research and development (R&D) company, launching a product into market may seem to be an issue for someone else to handle in the far-distant future and at a much later time. But even at laboratory or early development stages, biotechnology companies should understand the language of pharmaceutical companies and know how that industry operates. Doing so helps biotech companies make early decisions regarding their investigational products that could lead to future success.
WorkSure is a medical affairs management company that directs and plans for all drug-related publications such as abstracts, posters, and manuscripts. Such communications are essential for product commercialization. The organization is also responsible for developing a strategic plan that integrates and aligns the timing of clinical trial data locks with the release of key data points at scientific meetings. That plan outlines the timing of abstract submissions.
Another key role WorkSure is developing clear and consistent language to describe clinical results for the organization as a whole. A publication plan is even more critical after drug approval when a new product faces a competitive environment and clinical communities begin to incorporate it into their therapeutic programs. Each initiative must be planned and carefully coordinated to maximize the amount of exposure, recognition, and buzz for a new drug product.
WorkSure Medical Affairs Support
WorkSure experts are the key resources within medical affairs. WorkSure can address typical concerns about commercial drug products, including safety, efficacy, dosing, and administration. In addition, WorkSure experts (or other representatives from medical affairs) play active roles in the development of commercial materials and/or sales training. Developing such materials is essential for preparing a commercial team for a product launch.
WorkSure Medical Affairs Services
Following are the services/support being offered by WorkSure under Medical Affairs Management
Medico- Marketing & business development
€ Promoting ethical marketing practices
€ Marketing strategy support & guidance on therapy positioning across product life cycle
KOL management & interfacing responsibilities
€ Clinical research & regulatory activities
€ Clinical development plan
Pharmacoeconomic based clinical decision making
€ Pharmacovigilance & Regulatory support
€ Postmarketing safety and surveillance
Compliance, quality assurance and quality control
€ Medical education and training
€ Educational activities with external stakeholders
€ Regular training of internal stakeholders
€ Medical communications
€ Clinical Information Service eg. Field queries
€ Preparation & evaluation of scientific & promotional literature