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.
• Clarifying which steps must be taken to efficiently move from a transactional to a strategic relationship for swifter and more efficient change management
• Unraveling risk management techniques to minimize the damaging effects of project management and CRA turnovers in a volatile CRO environment • Optimizing the process for a successful project management transition to minimize risk, avoid escalation and optimize quality • Developing corrective and preventative action plans for efficient issue identification, management and – if necessary – escalation to preserve your most crucial clinical end-points • Defining the meaning of open communication and transparency to clarify the key terms of your relationship • Structuring a governance model to efficiently oversee all project activities• Developing a fit-for-purpose outsourcing framework to adapt your outsourcing activities to your development portfolio and financial capability
• Weighing out the advanatges and disadvanatges of the preferred provider model against the multiple vendor model to establish which factors are crucial to your outsourcing identify • Utilizing regional CROs in a global trial to establish a close working relationship and receive high quality amd more specialized services • Analyzing the operational complexities of selecting CROs in India to facilitate studu start-up• Examining the potential effects the new, strategic alliances between CROs and sponsors will have on overall trial efficiency
• Exploring if these alliances are providing cost and organizational efficiencies to trials • Emphasizing specialty services that are not always a core competency of CROs, such as patient enrollment and retention • Exploring if the alliances only exacerbate a growing problem that cannot afford to be insulated by preferred provider agreements• Defining the intricacies of a hybrid model to drive decisions on your outsourcing identity
• Narrowing down scope based on your personal needs and budget to determine which functions to outsource and which to keep in-house • Unveiling best practices in interfacing niche CROs with your global CRO to optimize the flow of information • Establish a time-efficient meeting framework to communicate expectations, needs and requirements in a consistent manner to maximize your RoI • Revealing best practices in handling scope changes to avoid unnecessary friction between outsourcing partners• Overcoming challenges in CRO budget estimation to guarantee on-budget delivery
• Determining the necessary level of thoroughness in CRO feasibility to enhance confidence in your selection • Evaluating if pre- or post-award feasibility will enhance efficiency to pinpoint the right time for feasibility • Understanding when you need to question investigators, which questions to ask and how to extract the information you need for healthy patient population numbers • Learning how to use feasibility as a de-risking tool• Drawing succinct conclusions from past vendor/sponsor relationships
• Comparing and contrasting hybrid, full-service, functional and preferred provider models to challenge common misconceptions of the advantages and disadvantages of these outsourcing styles • Understanding the reasons why some companies are consciously reducing their outsourcing activities • Scrutinizing resource management techniques when keeping clinical trials in-house • Dissecting real-life examples to devise an industry standard of best practices in outsourcing • Conducting a frank discussion over industry controversies to remove the veil of secrecy and generate real solutions to costly and time consuming problems: • data management • patient recruitment • change orders • site quality • study team turn-overs • study ownership • accountabilityStream A: Leveraging big pharma expertise to help you optimize global trial procedures
• Clarifying which steps must be taken to efficiently move from a transactional to a strategic relationship for swifter and more efficient change management
• Unraveling risk management techniques to minimize the damaging effects of project management and CRA turnovers in a volatile CRO environment • Optimizing the process for a successful project management transition to minimize risk, avoid escalation and optimize quality • Developing corrective and preventative action plans for efficient issue identification, management and – if necessary – escalation to preserve your most crucial clinical end-points • Defining the meaning of open communication and transparency to clarify the key terms of your relationship • Structuring a governance model to efficiently oversee all project activities• Developing a fit-for-purpose outsourcing framework to adapt your outsourcing activities to your development portfolio and financial capability
• Weighing out the advanatges and disadvanatges of the preferred provider model against the multiple vendor model to establish which factors are crucial to your outsourcing identify • Utilizing regional CROs in a global trial to establish a close working relationship and receive high quality amd more specialized services • Analyzing the operational complexities of selecting CROs in India to facilitate studu start-up• Examining the potential effects the new, strategic alliances between CROs and sponsors will have on overall trial efficiency
• Exploring if these alliances are providing cost and organizational efficiencies to trials • Emphasizing specialty services that are not always a core competency of CROs, such as patient enrollment and retention • Exploring if the alliances only exacerbate a growing problem that cannot afford to be insulated by preferred provider agreements• Defining the intricacies of a hybrid model to drive decisions on your outsourcing identity
• Narrowing down scope based on your personal needs and budget to determine which functions to outsource and which to keep in-house • Unveiling best practices in interfacing niche CROs with your global CRO to optimize the flow of information • Establish a time-efficient meeting framework to communicate expectations, needs and requirements in a consistent manner to maximize your RoI • Revealing best practices in handling scope changes to avoid unnecessary friction between outsourcing partners• Overcoming challenges in CRO budget estimation to guarantee on-budget delivery
• Determining the necessary level of thoroughness in CRO feasibility to enhance confidence in your selection • Evaluating if pre- or post-award feasibility will enhance efficiency to pinpoint the right time for feasibility • Understanding when you need to question investigators, which questions to ask and how to extract the information you need for healthy patient population numbers • Learning how to use feasibility as a de-risking tool• Drawing succinct conclusions from past vendor/sponsor relationships
• Comparing and contrasting hybrid, full-service, functional and preferred provider models to challenge common misconceptions of the advantages and disadvantages of these outsourcing styles • Understanding the reasons why some companies are consciously reducing their outsourcing activities • Scrutinizing resource management techniques when keeping clinical trials in-house • Dissecting real-life examples to devise an industry standard of best practices in outsourcing • Conducting a frank discussion over industry controversies to remove the veil of secrecy and generate real solutions to costly and time consuming problems: • data management • patient recruitment • change orders • site quality • study team turn-overs • study ownership • accountability• Understanding the greatest challenges in site contracting on a global level to devise effective solutions
• Implementing oversight strategies to efficiently manage CROs in the negotiations of site agreements and budgets • Heightening the site staff’s operational understanding of monitoring to iron out flaws and make your study more tangible • Justifying the time invested in training CRAs to exterminate the “box-checking” mentality • Implementing training methods on the intent of your protocol and instructing on root cause analysis to generate high-quality monitoring results • Establishing a direct line of communication between you, the CRAs and your CRO to achieve a feeling of true ownership of your study• Demonstrating the benefits of flexible IVRS when making packaging decisions
• Finding optimal supply algorithms within your study design to reduce drug waste • Optimizing the supply algorithms throughout the study to stay on course • Managing expiry and minimizing expiry wastage for optimal on-time delivery • Utilizing the tracking capabilities of IVRS to monitor product throughout the supply chain • Exploring the present and future role of IVRS in managing temperature-sensitive material• Setting up realistic timelines for study start-up in China to avoid costly delays
• Pinpointing the most common risk factors and identifying red flags in China to generate an accurate “big picture” plan for your study • Discovering novel ways to accelerate your protocol approval to significantly shorten timelines • Drawing on experiences in China to engage in proactive planning for effective risk mitigation: • Regulatory lead times • Country-specific challenges • Import-export issues • Identifying the most common deficiencies and delays in site initiation to ensure timely enrollment and avoid additional costs • Setting up tailored operational structures to overcome cultural differences for optimal study progress• Highlighting the advantages to both client and vendor in determining standards
• Pinpointing where to target client-vendor standardizations in an IVRS/IWRS for efficient results • Analyzing areas where standardization cost might outweigh benefits to prevent overstretching your budget • Exploring the perils of a reconfigurable system to create a targeted contingency planStream B: Break-out symposium designed exclusively for small- to medium biotech companies and vendor participants
• Clarifying which steps must be taken to efficiently move from a transactional to a strategic relationship for swifter and more efficient change management
• Unraveling risk management techniques to minimize the damaging effects of project management and CRA turnovers in a volatile CRO environment • Optimizing the process for a successful project management transition to minimize risk, avoid escalation and optimize quality • Developing corrective and preventative action plans for efficient issue identification, management and – if necessary – escalation to preserve your most crucial clinical end-points • Defining the meaning of open communication and transparency to clarify the key terms of your relationship • Structuring a governance model to efficiently oversee all project activities• Developing a fit-for-purpose outsourcing framework to adapt your outsourcing activities to your development portfolio and financial capability
• Weighing out the advanatges and disadvanatges of the preferred provider model against the multiple vendor model to establish which factors are crucial to your outsourcing identify • Utilizing regional CROs in a global trial to establish a close working relationship and receive high quality amd more specialized services • Analyzing the operational complexities of selecting CROs in India to facilitate studu start-up• Examining the potential effects the new, strategic alliances between CROs and sponsors will have on overall trial efficiency
• Exploring if these alliances are providing cost and organizational efficiencies to trials • Emphasizing specialty services that are not always a core competency of CROs, such as patient enrollment and retention • Exploring if the alliances only exacerbate a growing problem that cannot afford to be insulated by preferred provider agreements• Defining the intricacies of a hybrid model to drive decisions on your outsourcing identity
• Narrowing down scope based on your personal needs and budget to determine which functions to outsource and which to keep in-house • Unveiling best practices in interfacing niche CROs with your global CRO to optimize the flow of information • Establish a time-efficient meeting framework to communicate expectations, needs and requirements in a consistent manner to maximize your RoI • Revealing best practices in handling scope changes to avoid unnecessary friction between outsourcing partners• Overcoming challenges in CRO budget estimation to guarantee on-budget delivery
• Determining the necessary level of thoroughness in CRO feasibility to enhance confidence in your selection • Evaluating if pre- or post-award feasibility will enhance efficiency to pinpoint the right time for feasibility • Understanding when you need to question investigators, which questions to ask and how to extract the information you need for healthy patient population numbers • Learning how to use feasibility as a de-risking tool• Drawing succinct conclusions from past vendor/sponsor relationships
• Comparing and contrasting hybrid, full-service, functional and preferred provider models to challenge common misconceptions of the advantages and disadvantages of these outsourcing styles • Understanding the reasons why some companies are consciously reducing their outsourcing activities • Scrutinizing resource management techniques when keeping clinical trials in-house • Dissecting real-life examples to devise an industry standard of best practices in outsourcing • Conducting a frank discussion over industry controversies to remove the veil of secrecy and generate real solutions to costly and time consuming problems: • data management • patient recruitment • change orders • site quality • study team turn-overs • study ownership • accountabilityThese six uniquely designed sessions will bring together forward-thinking industry professionals and give them the opportunity to break with antiquated methods of vendor selection.
Our proactive and enthusiastic working group hosts will introduce seasoned professionals to a ground-breaking and innovative paradigm, challenging the formats of currently used RFP and bid proposal documents. The aim of each working group will be to drive the creation of a “Bill of Rights” for clinical outsourcing. Sponsors and vendors will engage in controversial debates and reveal what crucial information the RFP document must contain in order to provoke an equally well-designed bid document. This collaborative effort will physically produce two “ideal” templates per group and will serve as a prime example for generations to come. Upon conclusion of all six break-out sessions, we invite the leaders to come forth and present the results of each working party. The three-hour symposium will include 6 separate working groups and allow space for up to 12 participants per group. Please sign up upon arrival to the conference on March 27th. Workshop registration will close after lunch on Day 1 of the conference.Stream C: Refining study budgets to master scope management
• Clarifying which steps must be taken to efficiently move from a transactional to a strategic relationship for swifter and more efficient change management
• Unraveling risk management techniques to minimize the damaging effects of project management and CRA turnovers in a volatile CRO environment • Optimizing the process for a successful project management transition to minimize risk, avoid escalation and optimize quality • Developing corrective and preventative action plans for efficient issue identification, management and – if necessary – escalation to preserve your most crucial clinical end-points • Defining the meaning of open communication and transparency to clarify the key terms of your relationship • Structuring a governance model to efficiently oversee all project activities• Developing a fit-for-purpose outsourcing framework to adapt your outsourcing activities to your development portfolio and financial capability
• Weighing out the advanatges and disadvanatges of the preferred provider model against the multiple vendor model to establish which factors are crucial to your outsourcing identify • Utilizing regional CROs in a global trial to establish a close working relationship and receive high quality amd more specialized services • Analyzing the operational complexities of selecting CROs in India to facilitate studu start-up• Examining the potential effects the new, strategic alliances between CROs and sponsors will have on overall trial efficiency
• Exploring if these alliances are providing cost and organizational efficiencies to trials • Emphasizing specialty services that are not always a core competency of CROs, such as patient enrollment and retention • Exploring if the alliances only exacerbate a growing problem that cannot afford to be insulated by preferred provider agreements• Defining the intricacies of a hybrid model to drive decisions on your outsourcing identity
• Narrowing down scope based on your personal needs and budget to determine which functions to outsource and which to keep in-house • Unveiling best practices in interfacing niche CROs with your global CRO to optimize the flow of information • Establish a time-efficient meeting framework to communicate expectations, needs and requirements in a consistent manner to maximize your RoI • Revealing best practices in handling scope changes to avoid unnecessary friction between outsourcing partners• Overcoming challenges in CRO budget estimation to guarantee on-budget delivery
• Determining the necessary level of thoroughness in CRO feasibility to enhance confidence in your selection • Evaluating if pre- or post-award feasibility will enhance efficiency to pinpoint the right time for feasibility • Understanding when you need to question investigators, which questions to ask and how to extract the information you need for healthy patient population numbers • Learning how to use feasibility as a de-risking tool• Drawing succinct conclusions from past vendor/sponsor relationships
• Comparing and contrasting hybrid, full-service, functional and preferred provider models to challenge common misconceptions of the advantages and disadvantages of these outsourcing styles • Understanding the reasons why some companies are consciously reducing their outsourcing activities • Scrutinizing resource management techniques when keeping clinical trials in-house • Dissecting real-life examples to devise an industry standard of best practices in outsourcing • Conducting a frank discussion over industry controversies to remove the veil of secrecy and generate real solutions to costly and time consuming problems: • data management • patient recruitment • change orders • site quality • study team turn-overs • study ownership • accountabilityStream D: Fine-tuning quality control for exceptional study results
• Clarifying which steps must be taken to efficiently move from a transactional to a strategic relationship for swifter and more efficient change management
• Unraveling risk management techniques to minimize the damaging effects of project management and CRA turnovers in a volatile CRO environment • Optimizing the process for a successful project management transition to minimize risk, avoid escalation and optimize quality • Developing corrective and preventative action plans for efficient issue identification, management and – if necessary – escalation to preserve your most crucial clinical end-points • Defining the meaning of open communication and transparency to clarify the key terms of your relationship • Structuring a governance model to efficiently oversee all project activities• Developing a fit-for-purpose outsourcing framework to adapt your outsourcing activities to your development portfolio and financial capability
• Weighing out the advanatges and disadvanatges of the preferred provider model against the multiple vendor model to establish which factors are crucial to your outsourcing identify • Utilizing regional CROs in a global trial to establish a close working relationship and receive high quality amd more specialized services • Analyzing the operational complexities of selecting CROs in India to facilitate studu start-up• Examining the potential effects the new, strategic alliances between CROs and sponsors will have on overall trial efficiency
• Exploring if these alliances are providing cost and organizational efficiencies to trials • Emphasizing specialty services that are not always a core competency of CROs, such as patient enrollment and retention • Exploring if the alliances only exacerbate a growing problem that cannot afford to be insulated by preferred provider agreements• Defining the intricacies of a hybrid model to drive decisions on your outsourcing identity
• Narrowing down scope based on your personal needs and budget to determine which functions to outsource and which to keep in-house • Unveiling best practices in interfacing niche CROs with your global CRO to optimize the flow of information • Establish a time-efficient meeting framework to communicate expectations, needs and requirements in a consistent manner to maximize your RoI • Revealing best practices in handling scope changes to avoid unnecessary friction between outsourcing partners• Overcoming challenges in CRO budget estimation to guarantee on-budget delivery
• Determining the necessary level of thoroughness in CRO feasibility to enhance confidence in your selection • Evaluating if pre- or post-award feasibility will enhance efficiency to pinpoint the right time for feasibility • Understanding when you need to question investigators, which questions to ask and how to extract the information you need for healthy patient population numbers • Learning how to use feasibility as a de-risking tool• Drawing succinct conclusions from past vendor/sponsor relationships
• Comparing and contrasting hybrid, full-service, functional and preferred provider models to challenge common misconceptions of the advantages and disadvantages of these outsourcing styles • Understanding the reasons why some companies are consciously reducing their outsourcing activities • Scrutinizing resource management techniques when keeping clinical trials in-house • Dissecting real-life examples to devise an industry standard of best practices in outsourcing • Conducting a frank discussion over industry controversies to remove the veil of secrecy and generate real solutions to costly and time consuming problems: • data management • patient recruitment • change orders • site quality • study team turn-overs • study ownership • accountability
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