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Mark J.
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My Medical Department is a physician-led global medical consultancy, bringing excellence to the development and use of your products throughout their lifecycle. Our versatile team offers a range of solutions, tailored to your organisations specific needs. We are a specialized pharmaceutical medicine consultancy, providing a full array of medical team functions throughout the product life cycle. Our innovative service provides the operations of a full medical department, only charging for what you actually use. As a physician-led team committed to upholding patient safety, we place a strong focus on the quality of our work and integrity of decision-making. Please talk...
Strategy consultancy: competitive landscape analysis to inform strategic decisions portfolio management: in- and out-licensing; r&d stop-go decisions target product profiles & clinical development plans.,medical affairs: promotional claims optimisation,substantiation & defense compliance reviews and medical sign-off engagement with kols & other external stakeholders advisory board planning,implementation and write-up medical information functions field force training medical writing.,market access: medical elements of pricing & reimbursement strategy and health technology appraisals advanced budgetary notification formulary access materials; formulary submissions & defence meetings.,clinical trials phase i - iv: trial design optimisation to support promotional claims,pricing & reimbursement medical monitor / clinical research physician / clinical research scientist medical statistics & data oversight including sae reconciliation medical writing from protocol to csr clinical operations including cra,site monitoring,co-monitoring and recruitment optimisation activities forensic data management and bringing trials back “in-house”.,pharmacovigilance: medical review of safety information (icsr’s & literature): narrative writing; assessment of coding,causality and expectedness safety reporting: interim and cumulative reports; investigation of putative safety signals risk-benefit analysis to inform product label changes safety database and qppv by arrangement.,and other services: we can provide and manage a range of other services via existing collaboration agreements with our network of experts including: compliance & audit; regulatory affairs; biostatistics; health economics.
My medical department operates in the Pharmaceutical manufacturing industry.
My medical department's revenue is 11m - 100m
My medical department has 11 - 50 employees.
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