My Medical Department

pharmaceutical manufacturing

Recruiting

Contact Management

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

substantiation & defense Compliance reviews and medical sign-off Engagement with KOLs & other external stakeholders Advisory Board planning

Clinical Trials phase I - IV: Trial design optimisation to support promotional claims

Medical Affairs: Promotional claims optimisation

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.

Health Care

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.

co-monitoring and recruitment optimisation activities Forensic data management and bringing trials back “in-house”.

Consulting

Pharmacovigilance: Medical review of safety information (ICSR’s & literature): narrative writing; assessment of coding

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.

site monitoring

implementation and write-up Medical Information functions Field force training Medical writing.

Outsourcing

Market Access: Medical elements of pricing & reimbursement strategy and Health Technology Appraisals Advanced budgetary notification Formulary access materials; formulary submissions & defence meetings.