Clinical Data, Clinical Operations and Statistics are highly dynamic groups in the clinical development arena. 2016 will bring important changes in the European regulatory framework once the ICH E6 Addendum kicks in with the following guidances:
- Sponsors will be expected to implement a system to manage quality throughout the design, conduct, recording, evaluation, reporting and archiving of clinical trials.
- The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collection. Protocols, case report forms, and other operational documents should be clear, concise and consistent.
- The sponsor should ensure oversight of any trial-related duties and functions carried out on its behalf. The sponsor should develop a systematic, prioritized, risk-based appraoch to monitoring clinical trials. A combination of on-site and centralized monitoring activities may be appropriate. The sponsor should document the rationale for the chosen monitoring strategy (e.g. in the monitoring plan).
These changes will impact how we manage clincial development operationally with quality embedded through operational excellence not a goal but an expectation.
In three parallel themes, Data Management, Clinical Operations and Statistics will be examined through presentation, case studies and discussion focusing on how to achieve operational excellence. During a joint plenary session, topics that bind both groups will be discussed: Risk-based Monitoring, the status of eSource and independent 3rd parties, and Quality Management in Outsourcing.
Who should attend?
- Professional working with clinical operations
- Clinical data management professionals
- Process optimization leads and managers
- Trial managers
- Field monitors
- Site representetatives, Site leads
- Project data managers
- Professionals working in the interface between CROs and Sponsors
- Vendor managers
- Pharma IT professionals (working in highly regulated environment)
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