- Identification of the Data
- THE BODY OF EVIDENCE
Meta-Works® comprehensively identifies and evaluates all potential sources of evidence sourced from companies, the Biomedical and Grey literature including systematic reviews, comparative & non comparative studies, regulatory agency evaluations, non-published company studies or submissions, clinical guidelines, symposiums, medical databases & registries, company market research surveys.
- GOLDEN RETRIEVER® Library Service
Meta-Works® can employ its own international library service for speed of access particularly where extensive search strategy and multiple database extractions are involved. This fast and cost effective service can be offered to clients on an ongoing basis.
- THE BODY OF EVIDENCE
- Qualification and Extraction of the Data
Not all evidence is equal and can vary inordinately with respect to study quality and relevance of application. As part of any project discipline Meta-Works® critically appraises the research to ensure fitness of propose.
Meta-Works® also contextualises the data in relation to the local market context. This may involve referencing or surveying key opinion leaders, consumer advocacy groups, treatment clinics, professional & clinical practice guidelines.
- Analysis of the Data
Meta-Works® regularly compiles statistical plans and performs data extraction in preparation of detailed statistical analyses such as comparative effectiveness reviews to ensure thorough scientific analysis and the robustness of new research analysis performed. Our epidemiologists and statisticians have applied expertise in regulatory affairs and in clinical trials and are experts at complex modelling and technical remedies with respect to common research problems e.g. missing data, surrogate outcomes, identifying and compensating for heterogeneity factors defining clinical outcomes.
- Presentation of the Evidence to best make your case
Good commercial argumentation and successful submissions rely on a clear and compelling presentation of the evidence. Having the best evidence and making the best presentations of the evidence are two different things. At Meta-Works® we pride ourselves in structuring the evidence to provide articulate and persuasive presentations to best demonstrate our client cases and positions.
- Seeing the Application Through
Complex files supported by disparate data and that involve high level statistical and comparative methodologies for example are more prone to cross-examination by the regulator and therefore can require a level of expert mediation. To assist our clients in mitigating against such risk, Meta-Works® supports its projects where required with expert mediation services to ensure safe passage and to expedite timelines.