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.
First round of meet and greet: enjoy a steaming hot coffee and sample our breakfast buffet to break the ice.
• Examining the current trend towards CRO mergers to alleviate pressures and burdens on clinical-stage drug manufacturers
• Recognizing the decline of flexibility due to mergers and understanding how this is affecting competitive pricing • Screening for proof of financial stability and the likelihood of an acquisitions to secure the uninhibited completion of your study agreement • Negotiating damage control procedures to avoid confusion and guarantee a seamless transition of SOPs in a merger situation • Generating internal and external transition plans to control unexpected workload and uphold the integrity of all documentation • Leveraging your bargaining power in anticipation of an ever-declining pool of CROs• Sharing best practices on how to combine project management and clinical operations to yield truly spectacular results
• Implementing cross-functional procedures to effectively measure the quality of deliverables for uncompromising compliance • Defining detailed deliverables and setting clear and realistic timelines in your scope of work to track metrics effortlessly • Devising a clear escalation plan for quality flags to circumvent time-consuming micromanagement • Understanding how small biopharmaceutical companies can structure the need for a niche service in your RFP to attract the most qualified experts in the field • Unearthing the most glaring differences between existing CROs to drive better decisions regarding your outsourcing profile• Developing a sound communication plan to ensure all parties work towards the same ultimate goal
• Understanding what steps have to be taken to keep things running smoothly during study team turn-overs, change in scope, lagging enrollment, etc
• Weighing up the advantages and disadvantages of working with strategic partners vs multiple providers to give you a better understanding of what works for you
• Alliance management - examining which management techniques require the least investment of your time while ensuring maximum oversight
• Striving for standardization that creates efficiencies during the site start-up phase, promoting cost and time savings
• Utilizing compliance directories as a method to document training and conserve resources • Exploring investigator meeting options to maximize your investment • Implementing automated qualification processes that can streamline your site selection process as well as validate roles for participation • Standardizing role qualification at the site level (e.g. Rater) and facilitating sponsor validation of qualified personnel against the established standard • Uncovering the latest trends to ensure that you get the most out of available technologies• Delineating the inadequacies of conventional vendor selection methods to champion a paradigm
• Adopting a “reverse order” selection method to eliminate any doubt of your vendor’s compatibility and competence • Forming long-lasting and profound relationships with business development representatives to convey a thorough understanding of your personal business needs • Pursuing a result-oriented familiarization process to test your vendor’s commercial cunning • Learning what steps you must take for efficient pre-selection to avoid wasting your money on directionless requests for proposal • Understanding that vendor selection based on people rather than on price will result in a higher quality bid• Establishing joint stirring committees to strengthen your position and prestige within larger CROs
• Learning what steps you must take to effectively implement a communication plan for a seamless and timely team transition • Analyzing your vendor’s turnover rate on specific projects to avoid a significant disruption of workflow • Arranging intricate provisions to mitigate the onerous burdens of the transition period • Sharing your internal timelines and milestone with your CRO to gain sufficient overlap time with the new team member for a wholesome transfer of information • Discovering which contract measures you can employ to secure yourself against frequent team changes• Weighing out the pros and cons of hiring independent CRAs versus contracting CRAs through a contract research organization to develop a customized outsourcing plan
• Evaluating which factors favor independent CRAs and discovering effective management techniques for successful study completion • Analyzing the implications of working with a CRO and implementing provisions to make it work • Leveraging expert knowledge to accurately project your future resourcing needs • Inspecting resourcing decisions made by small, mid-sized and large pharma and biotech companies to help you find the path to success• Understanding the goals and benefits of Russia's new clinical trial regulations that went into effect September 2010
• Scrutinizing major changes and new requirements resulting from the new legislation • Uncovering challenges related to the new regulations and status of implementation • Evaluating clinical trial metrics for studies being conducted in Russia before and after introduction of the new lawThis is your chance to find out more about your fellow delegates and discover what wonders the exhibitors have to offer.
A quick breather before we continue our exciting program.
Stream A
Industry experts present case study-based FTE cost analyses to help you take supported outsourcing decisions
First round of meet and greet: enjoy a steaming hot coffee and sample our breakfast buffet to break the ice.
• Examining the current trend towards CRO mergers to alleviate pressures and burdens on clinical-stage drug manufacturers
• Recognizing the decline of flexibility due to mergers and understanding how this is affecting competitive pricing • Screening for proof of financial stability and the likelihood of an acquisitions to secure the uninhibited completion of your study agreement • Negotiating damage control procedures to avoid confusion and guarantee a seamless transition of SOPs in a merger situation • Generating internal and external transition plans to control unexpected workload and uphold the integrity of all documentation • Leveraging your bargaining power in anticipation of an ever-declining pool of CROs• Sharing best practices on how to combine project management and clinical operations to yield truly spectacular results
• Implementing cross-functional procedures to effectively measure the quality of deliverables for uncompromising compliance • Defining detailed deliverables and setting clear and realistic timelines in your scope of work to track metrics effortlessly • Devising a clear escalation plan for quality flags to circumvent time-consuming micromanagement • Understanding how small biopharmaceutical companies can structure the need for a niche service in your RFP to attract the most qualified experts in the field • Unearthing the most glaring differences between existing CROs to drive better decisions regarding your outsourcing profile• Developing a sound communication plan to ensure all parties work towards the same ultimate goal
• Understanding what steps have to be taken to keep things running smoothly during study team turn-overs, change in scope, lagging enrollment, etc
• Weighing up the advantages and disadvantages of working with strategic partners vs multiple providers to give you a better understanding of what works for you
• Alliance management - examining which management techniques require the least investment of your time while ensuring maximum oversight
• Striving for standardization that creates efficiencies during the site start-up phase, promoting cost and time savings
• Utilizing compliance directories as a method to document training and conserve resources • Exploring investigator meeting options to maximize your investment • Implementing automated qualification processes that can streamline your site selection process as well as validate roles for participation • Standardizing role qualification at the site level (e.g. Rater) and facilitating sponsor validation of qualified personnel against the established standard • Uncovering the latest trends to ensure that you get the most out of available technologies• Delineating the inadequacies of conventional vendor selection methods to champion a paradigm
• Adopting a “reverse order” selection method to eliminate any doubt of your vendor’s compatibility and competence • Forming long-lasting and profound relationships with business development representatives to convey a thorough understanding of your personal business needs • Pursuing a result-oriented familiarization process to test your vendor’s commercial cunning • Learning what steps you must take for efficient pre-selection to avoid wasting your money on directionless requests for proposal • Understanding that vendor selection based on people rather than on price will result in a higher quality bid• Establishing joint stirring committees to strengthen your position and prestige within larger CROs
• Learning what steps you must take to effectively implement a communication plan for a seamless and timely team transition • Analyzing your vendor’s turnover rate on specific projects to avoid a significant disruption of workflow • Arranging intricate provisions to mitigate the onerous burdens of the transition period • Sharing your internal timelines and milestone with your CRO to gain sufficient overlap time with the new team member for a wholesome transfer of information • Discovering which contract measures you can employ to secure yourself against frequent team changes• Weighing out the pros and cons of hiring independent CRAs versus contracting CRAs through a contract research organization to develop a customized outsourcing plan
• Evaluating which factors favor independent CRAs and discovering effective management techniques for successful study completion • Analyzing the implications of working with a CRO and implementing provisions to make it work • Leveraging expert knowledge to accurately project your future resourcing needs • Inspecting resourcing decisions made by small, mid-sized and large pharma and biotech companies to help you find the path to success• Understanding the goals and benefits of Russia's new clinical trial regulations that went into effect September 2010
• Scrutinizing major changes and new requirements resulting from the new legislation • Uncovering challenges related to the new regulations and status of implementation • Evaluating clinical trial metrics for studies being conducted in Russia before and after introduction of the new lawThis is your chance to find out more about your fellow delegates and discover what wonders the exhibitors have to offer.
• Highlighting the advancement of Saas models and assessing their impact on contracting to achieve shorter contracting timelines
• Balancing Saas and contracting services to manage costs
• Accurately aligning standards and processes to reduce costs and timelines
• Implementing thought-provoking changes of support models in the era Saas
• Determining the risk associated with keeping management in-house
• Analyzing your internal resourcing to devise the most cost-effective vendor management structure • Calculating the RoI of outsourcing based on a given study scenarioA quick breather before we continue our exciting program.
• Determining the risk associated with giving up control over CRA management
• Analyzing your internal resourcing to devise the most cost-effective vendor management structure • Calculating the RoI of outsourcing based on a given study scenario• Comparing and contrasting the outcomes of the FTE analyses
• Applying effective problem-solving measures to arrive at a common understanding of the underlying issues • Drawing sound conclusions based on the case study results • Challenging conventional partnership models and amending outsourcing techniques to achieve higher profitsStream B
Strengthen your investigator relations and maximize quality on site to overcome the Number One delay in clinical trials
First round of meet and greet: enjoy a steaming hot coffee and sample our breakfast buffet to break the ice.
• Examining the current trend towards CRO mergers to alleviate pressures and burdens on clinical-stage drug manufacturers
• Recognizing the decline of flexibility due to mergers and understanding how this is affecting competitive pricing • Screening for proof of financial stability and the likelihood of an acquisitions to secure the uninhibited completion of your study agreement • Negotiating damage control procedures to avoid confusion and guarantee a seamless transition of SOPs in a merger situation • Generating internal and external transition plans to control unexpected workload and uphold the integrity of all documentation • Leveraging your bargaining power in anticipation of an ever-declining pool of CROs• Sharing best practices on how to combine project management and clinical operations to yield truly spectacular results
• Implementing cross-functional procedures to effectively measure the quality of deliverables for uncompromising compliance • Defining detailed deliverables and setting clear and realistic timelines in your scope of work to track metrics effortlessly • Devising a clear escalation plan for quality flags to circumvent time-consuming micromanagement • Understanding how small biopharmaceutical companies can structure the need for a niche service in your RFP to attract the most qualified experts in the field • Unearthing the most glaring differences between existing CROs to drive better decisions regarding your outsourcing profile• Developing a sound communication plan to ensure all parties work towards the same ultimate goal
• Understanding what steps have to be taken to keep things running smoothly during study team turn-overs, change in scope, lagging enrollment, etc
• Weighing up the advantages and disadvantages of working with strategic partners vs multiple providers to give you a better understanding of what works for you
• Alliance management - examining which management techniques require the least investment of your time while ensuring maximum oversight
• Striving for standardization that creates efficiencies during the site start-up phase, promoting cost and time savings
• Utilizing compliance directories as a method to document training and conserve resources • Exploring investigator meeting options to maximize your investment • Implementing automated qualification processes that can streamline your site selection process as well as validate roles for participation • Standardizing role qualification at the site level (e.g. Rater) and facilitating sponsor validation of qualified personnel against the established standard • Uncovering the latest trends to ensure that you get the most out of available technologies• Delineating the inadequacies of conventional vendor selection methods to champion a paradigm
• Adopting a “reverse order” selection method to eliminate any doubt of your vendor’s compatibility and competence • Forming long-lasting and profound relationships with business development representatives to convey a thorough understanding of your personal business needs • Pursuing a result-oriented familiarization process to test your vendor’s commercial cunning • Learning what steps you must take for efficient pre-selection to avoid wasting your money on directionless requests for proposal • Understanding that vendor selection based on people rather than on price will result in a higher quality bid• Establishing joint stirring committees to strengthen your position and prestige within larger CROs
• Learning what steps you must take to effectively implement a communication plan for a seamless and timely team transition • Analyzing your vendor’s turnover rate on specific projects to avoid a significant disruption of workflow • Arranging intricate provisions to mitigate the onerous burdens of the transition period • Sharing your internal timelines and milestone with your CRO to gain sufficient overlap time with the new team member for a wholesome transfer of information • Discovering which contract measures you can employ to secure yourself against frequent team changes• Weighing out the pros and cons of hiring independent CRAs versus contracting CRAs through a contract research organization to develop a customized outsourcing plan
• Evaluating which factors favor independent CRAs and discovering effective management techniques for successful study completion • Analyzing the implications of working with a CRO and implementing provisions to make it work • Leveraging expert knowledge to accurately project your future resourcing needs • Inspecting resourcing decisions made by small, mid-sized and large pharma and biotech companies to help you find the path to success• Understanding the goals and benefits of Russia's new clinical trial regulations that went into effect September 2010
• Scrutinizing major changes and new requirements resulting from the new legislation • Uncovering challenges related to the new regulations and status of implementation • Evaluating clinical trial metrics for studies being conducted in Russia before and after introduction of the new lawThis is your chance to find out more about your fellow delegates and discover what wonders the exhibitors have to offer.
• Fine-tuning efficient internal staffing vs external resourcing for Phase 1-3 clinical development to maximize flexibility and easily adapt resources to your fluctuating pipeline
• Elaborating on therapeutic area considerations for an in-depth understanding of the underlying factors in vendor selection • Inspecting development phase-related utilization of external CROs/vendors to help shape your outsourcing identity • Analyzing the most crucial issues in CRO/vendor selection for U.S. vs ex-U.S clinical trials to optimize your decision-making process• Uncovering the need for disruptive change in patient enrolment
• Exploring the new strategic alliances between CROs and sponsors
• Understanding how to transform clinical trials to leverage existing patient enrollment solutions
• Implementing four simple, but significant, steps to align the enrollment process with today’s clinical trial realities
A quick breather before we continue our exciting program.
• Learning how to effectively inspect sites and identify their weaknesses for extraordinary enrolment results
• Applying tried and tested training strategies for CRAs to boost their understanding of your product • Streamlining procedures across a multitude of sites to eliminate protocol deviations • Structuring CRA meetings in a logical and time-efficient manner and implementing interactive Q & A sessions to achieve unity among CRAs• Tightening investigator and site relationships to maximize patient recruitment numbers
• Internalizing best practices in explaining your study to clinicians for a statistically powered outcome • Ensuring unequivocal understanding of your inclusion/exclusion criteria by the site staff to obtain flawless statistical proof of the efficacy of your drug • Unveiling what motivates investigators to get involved in clinical trials to optimize your relationship • Devising effective training techniques to streamline monitoring procedures and minimize protocol deviations
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