Programme

Registration and refreshments

Chairman’s opening remarks

Keynote presentation: Delving into CDISC standards in order to fully comprehend the requirements that will be mandatory

• Providing an overview of the CDISC standards currently in use in order to be aware of all the requirements

• Explaining the reasons behind guidelines becoming mandatory requirements in efforts to implement them fully

• Examining how CDASH, SDTM and ADaM provide an end-to-end solution for the industry from the point of capture to submission to appreciate the need for these standards

• Revising the timelines the industry will have to work with in order to ensure in time implementation

• Outlining the consequences industry will face if on time implementation is not followed in order to appreciate the importance of compliance

Establishing the right metrics to be used from the data collected in order to judge performance and look for areas of improvement

• Considering the importance of being able to use the data to determine the level of performance in order to have a successful clinical trial

• Reviewing what data and in what way it can be used for this analysis in order to make the right choices of metrics

• Determining the significance of being able to choose the right metrics in order to successfully analyze the data collected

• Assessing potential ways the right metrics can be chosen for data analysis in order to identify the areas of improvement and move forward with the study

• Outlining the importance of adjusting the metrics used for the analysis of data of different types of studies in order to choose the right ones

• Exploring ways metrics can be used to assist for improvement identification to ensure delivery of high quality data through many crossfunctional groups

Keynote presentation: The eClinical Platform – Making order out of chaos

• Understand how the best-of-breed approach to implementing clinical trial applications has led to technology chaos, a lack of workflow and a lack of interoperability

• Assessing the effectiveness of current trends that promise to unify and simplify the eClinical ecosystem

• Understanding why clinical technology providers are taking advantage of the Cloud and how biopharma and CRO users are benefitting

• Exploring ways that biopharma companies are leveraging old and new tools in regards to Direct-to-Patient trials in efforts to achieve more

• Explaining eClinical Platform and how it differs from integrated systems in efforts to consider the implications of moving from independent systems to a complete platform

Morning refreshments and networking

Identifying the challenges associated with data issues when working with a vendor during a clinical trial in order to determine the best resolution

• Considering the amount of queries that might have to be dealt with during a study in order to appreciate the importance of dealing with them efficiently

• Reviewing the process of setting up queries while reviewing the data in order to determine the right person to generate them

• Appreciating the importance of choosing the right person to deal with a query in order to ensure that all the parties involved in the study are up to date

• Assessing the significance of dealing with a query and updating the data in order to move forward with the clinical trial

• Choosing the best procedure to follow while setting up a query in order to do it efficiently and effectively

• Determining the right person who would be responsible to close the query in order to verify it and to ensure it has been dealt with properly

Defining the procedures that should be followed in regards to data standards and input into the system in order to ensure the most efficient study start-up

• Providing a general overview of the time taken to input the data into the system before the trial begins in order to appreciate the timelines and the importance of reducing those

• Considering the challenges associated with a swift study start-up in regards to data input in efforts to identify the areas of a start-up that can be improved

• Providing ways to think well in advance and ahead of the schedule in order to use data set-ups available and hence reduce the time taken for a study start-up

• Determining the most efficient way to ensure vendors have received all the data specification needed in order to start a clinical trial

• Outlining data standards that can be used from previous studies for a new one in order to start the trial more efficiently

• Ensuring edit checks are in place in order to reduce the time taken for a study start-up

Session reserved for a representative from Cytel

Cytel presents a case study revealing new strategies in data management planning and handing technologies proven to streamline the submission process.

Lunch and Networking

Outlining ePRO methods and the problems associated with them to determine the most efficient data recording system depending on the type of the trial

• Revising the methods patients use to record data during a study without a visit in order to provide a brief overview

• Considering the reasons behind the use of ePRO methods rather than patients visiting a physician in order to justify these methods

• Examining the problems associated with the data collection when using self-recording systems in order to look for an improvement

• Assessing the importance of the use of the self-recorded data during a study in order to decide whether the study can be carried forward without worrying about standardization of this data

• Explaining the impact of self recording data systems have on data capture, both paper and electronic in order to assess the impact on data managers

• Exploring the latest ePRO technologies to establish how those can be incorporated within your company

Considering the role of the user experience in the quality of clinical trial data in order to improve productivity and satisfaction

• Appreciating the importance of user experience as an important variable in order to achieve better return on your investment

• Learning on how to make it part of your process in order to successfully implement solutions, services and processes

Promoting collaboration by leveraging technology in order to accelerate clinical research

• Outlining pharmaceutical trends with the use of customer information and patient data for secondary use

• Understanding cloud-based services in pharma: standardization yet consideration of researcher needs

• Examining actual customer case studies for customer/partner portals, CRO integration and a unified health data exchange

• Uncovering how competing pharmaceutical companies can share a common platform in order to cut incurring costs

• Determining where Bid Data fits into better serving your customers

Afternoon refreshments and networking

Establishing the challenges associated with risk based monitoring in order to save resources

• Choosing the best way of working effectively with the CRA team in order to save time

• Determining the frequency of site visits in order to use time efficiently

• Finding the most efficient method to ensure the sites are aware of all the tasks that need to be done in order to provide the right training if needed

• Outlining the right elements from the data that need verification in order to be able to choose the right sites that need to be monitored

• Examining the best way to make use of the resources in order to save the resources

• Ensuring the data has been verified in accordance with the protocol to make sure there will be no need to re-record the verified data

Considering how risk based monitoring can be equated to risk based data cleaning in order to compare and contrast

• Defining risk based monitoring in order to establish the impact it has on data cleaning

• Assessing options available when risk based monitoring goes wrong

• The knot in the water hose effect

Chairman’s summation and close of day one