LATE AND POST-APPROVAL
Real World Evidence in the form of late-phase clinical studies (Phases IIIb and IV) constitutes a rapidly expanding segment of the clinical research environment and regulation of the biopharmaceutical marketplace by bridging the gap from development to commercialisation. Increasing globalisation has fuelled changes in the regulatory environment, increasing data requirements at various stages of product development, validation, approval and production, including the long-term safety and efficacy when new products are used by broader patient populations in real-world settings. Healthcare providers and those who pay for healthcare are demanding that new therapies provide better outcomes or greater value than existing standards of care and are increasingly looking for real-world clinical evidence to support these claims.
By applying our unique design and operational approaches, specifically focused on Late Phase Research, we can ensure reliable results and cost effective research in the management of participating sites, data management and analytical processes, and of the overall project.
- Clinical Research Consulting
- Study design and protocol development
- Trial management and monitoring
- Regulatory and Ethics Committee expertise
- Clinical site evaluation, selection and management
- Pharmacovigilance services
- Data management and biostatistics
- Complementary and Alternate Medicine (CAM) registration consulting
Successful market access is increasingly contingent on real-world evidence of product value and the ability to show a positive impact on relevant, patient-related outcomes. Prospective observational studies using primary research have the power to provide the critical proof points among identified patient populations including key information on product safety and effectiveness and the natural history of diseases under standard conditions of care.
TCD Outcomes Research combines a solid, best-practice primary data collection capability and a focused scientific team to meet the growing demand for real-world evidence demonstrating the value of the investment in Health Care programmes and products.
Patient registries are observational studies that focus on understanding how the treatments, tests and services that are used in routine clinical care and by specialists affect patient health outcomes. TCD Outcomes Research assists clients in appropriately designing, conducting, and analysing data collected from patient registries and by doing so, provide unique scientific information about the effectiveness, safety and quality of the health-care service or intervention that is being studied. In recent years, the use of registries as a method for generating new scientific evidence has grown considerably. This trend is likely to continue in the future, particularly as manufacturers, regulators and other decision-makers seek objective information to augment what is known from clinical trials and other research studies about the harms and benefits of tests and therapies.
Relevant, real-world outcomes information on new pharmaceutical technologies is increasingly critical to obtain regulatory approval and market access. Retrospective observational outcomes studies, utilising comprehensive patient-level databases, are valid and trusted tools in the decision-making process, with the power to verify product value for money, understand effectiveness in real-life settings and identity issues that may only surface after long-term clinical use.
MARKET ACCESS SOLUTIONS
Our needs assessment services provide our clients with the access intelligence and strategic foresight necessary to maximise a product’s value within the funded healthcare market.
TCD Outcomes Research offers targeted, actionable recommendations for pricing products using value-based pricing solutions and innovative access strategies to ensure optimal patient access and reimbursement for our clients.
Our extensive experience in gathering scientific evidence through literature review, health economic modeling and database analyses using robust methodology and insightful approaches in a wide range of therapeutic areas.
Our health economics methodologies include:
- Cost of illness studies
- Budget impact analyses
- Cost minimisation studies
- Cost-effectiveness, cost-utility and cost-benefit models
Database analyses serve to elicit evidence on resource utilisation, treatment patterns, and patient and risk characterisation within a defined therapeutic area.
Given our extensive understanding of the ever increasing complex health care market, TCD Outcomes Research is well placed to provide our clients with the recommendations and insights needed to appropriately communicate value to the stakeholders who will determine access and extent of utilisation. Commonly, this is in the form of a Value Story. Value stories package the scientific evidence in a creative way and allow the value of a product to be effectively communicated to specific stakeholders.
• Strategic and Needs Assessments
• Study Protocol design
• Risk-Benefit & Risk Management
• Patient Reported Outcomes
• Literature Reviews and Meta-Analyses
• Monitoring and Evaluation
• Medical Writing
• Pharmacoeconomic Training
Whether you require us to assist in conducting a literature review; to carry out statistical analysis of your data or write the statistical analysis plan for your study or help your market access team understand the concepts and lingo used in health economics, we offer a range of tailored consultancy services geared to address the specific needs of our clients.