Here is an overview of the conference programme. You can browse by category to see full details of the sessions you are most interested in or click on the tabs on the interactive calendar to see what's on each day. Clicking on any of the speakers or sponsors will show you more information about them and why they are supporting this event.
• Re-engineering the current business model to allow for the inclusion of innovative technology solutions to drive efficiency in the process
• Addressing the need for organizational realignment to ensure that roles and responsibilities are clarified in the process of change • Identifying management commitment as a requirement to assist the sponsor firms to adapt to a culture embracing technology • Revising and developing existing legacy procedures to accommodate the re-engineered processes and procedures • Defining technology driven strategies and initiatives to alleviate the significant pressure to market a medicine as early as possible within its patent life to maximize the period without competition and increase total revenue• Outlining the benefits of workflow and active management to ensure timely and accurate completion of eCRFs
• Implementing visual tools and functionality in an EDC system to assist Sites and Monitors/CRAs in prioritizing tasks
• Discussing metrics and KPI to manage study timelines and budgets (site, CRA payments)
• Achieving high eCRF completion rates for interim analyses
• Seamlessly managing multiple protocol amendments based on site IRB approvals
• Offering protocol-guided data entry and data validation checks
• Addressing the recent changes that have been involved in the area of clinical data management to understand reasons for why the industry is moving forward
• Turning data into meaningful information to allow for faster, accessible assessments of information • Standardizing protocols to produce consistent criteria between studies • Archiving and storing of data appropriately to allow for highlighting the appropriate target population with a specific indication • Enabling continual assessment of innovative study initiatives and new clinical programmes to allow for constant improvement • Ensuring a robust clinical product pipeline to allow data to be accessible at a later time• Addressing the increase in regulatory requirements by investing in technology solutions to cope with the added pressures
• Adding an additional emphasis on business process re-engineering and improvement to engender long term clinical efficiencies and cost benefits • Outlining effective clinical data management functions to substantiate early approval for new product launch • Defining measures to minimize delay, deficiency or problems with quality to drive down cost of current CDM processes • Increasing the demand for sponsors to strike the right balance between time, cost, process and quality in conducting all clinical studies to ensure equal measures are placed upon the most important factors • Establishing the superior benefits of the growing area of EDC which will aim to provide ease where collaboration, standardization initiatives and technology innovation are constantly geared towards more wider technology adoption• Reviewing of international regulatory requirements for DMCs
• Addressing increased responsibilities for sponsors of adaptive design trials
• Identifying methods for building firewalls to protect sensitive data
• Automating generation of supporting documentation for interim analysis and safety monitoring
• Using computer systems to better secure clinical data and build regulatory trust
• Outlining tried and tested current outsourcing approaches to determine what would be suitable for you
• Analysing the associated challenges and benefits associated with; inhouse, outsourcing and off-shoring procedures to maximize return within your trial • Selecting the most appropriate technology vendor, platform or application to address the unique requirements of the clinical trial investigator and patients • Defining how to select the right approach based on study type, cost, time and quality of the results • Analyzing challenges associated with subcontracting work with vendors to explain how to address and overcome this in future studies • Implementing the required amount of oversight and expertise to drive CRO data management or database design deliverables• Describing the process of managing your data from end to end
• Outlining what it means to create a data standards roadmap
• Perceiving challenges of an end to end standards roadmap
• Underlining the importance of CDISC Data Standards
• Reviewing the current and future agency involvement with regards to requesting data in standard format
• Outlining the benefits of paper CRF for small-size entries even from a central location or outsourced CRO as a cost-effective approach to data input
• Involving the clinical data managers and CRF designers with the earliest development of the strategies and tools for collection within this current mixed PDC and EDC environment • Learning from the challenges experienced by larger companies that have turned to EDC technology to achieve a optimal level of work • Appreciating the long term benefits of pursuing EDC-enabled global strategies to ensure consistent implementation in current and future studies • Investing in new hardware and software for EDC technology in a rapidly changing operational environment• Defining the importance for data managers to understand the various sources of the data and the form in which the data will be received to ensure that the process of data input is conducted in an efficient manner
• Successfully integrating participation of the whole team during study design to allow necessary understanding of the required data • Involving the whole study team from the planning stage of the study to ensure the expected standards are met with respect to data quality • Considering CRF as an interdisciplinary system; not only requiring technical skills but also expertise and scientific reasoning in the subject therapeutic areas • Recognizing the design of the CRF or eCRF as a key quality step to ensure the data required by the protocol, regulatory compliance and study scientific- specific hypothesis attributes are addressed • Defining what is mission critical; all functional teams to be represented in form review meetings to ensure feedback is incorporated into the revised and finalized forms• Enabling an objective analysis through the use of consistent ; definitions, data management processes and standards across all studies
• Identifying the need of performance comparisons to ensure optimized efficiency and manage achievement of key milestones along the complex critical path • Outlining the benefits of defining clinical terms, data entry guidelines and data handling conventions to ensure a meaningful and persistent set of data is compiled • Incorporating the above into written guidelines to be used for CRF or eCRF completion • Testing CRFs and guidelines thoroughly by means of a pilot use amongst clinical data management or verification staff to guarantee long-term consistency of the process• Addressing applicable regulations and expectations of ePRO to ensure compliance from the patient during the study
• Introducing the FDA guidance on ePRO and computerized systems to ensure expectations are continually met
• Outlining the current efficiency models being used for computer system validation
• Selecting the right tool for the study phase to maximize efficiency within the process
• Determining the fundamental elements of data quality to achieve optimal results
• Incorporating web-based ePRO into the varied landscape of phase IV studies to provide you with more complete data for your trial
Back to main site