The Changing Outsourcing Paradigm from Service to Strategic Partnership: The Vendor Viewpoint
N. Susan Slagle
V.P. Project Management, inVentiv Clinical Solutions
Massachusetts Biotechnology CouncilBiostatistics and Data Management CommitteeOctober 7, 2008
Confidential inVentiv Clinical Solutions 2008
The Changing Outsourcing Paradigm
Macro Viewpoint Drug and Biotech companies are
increasing their R&D budgets to build out their product pipelines which will increase their use of outsourcing (Moody’s Global Corporate Finance August 2008)
Drug companies are under intensifying political and scientific attack regarding safety and high cost of their products
Generic versions are on the rise and threaten market share and revenue
Confidential inVentiv Clinical Solutions 2008
Confidential inVentiv Clinical Solutions 2008
The Changing Outsourcing Paradigm
Sponsor Viewpoint Sponsors are looking for outsourcing solutions
that result in cost savings, better utilization of internal/ external resources and high quality outcomes
Biotech firms which concentrate on discovery often lack the infrastructure to conduct clinical trials and take a product to approval
Clinical Trials are increasing in complexity and difficulties in patient enrollment are pushing companies to find treatment naïve populations in regions such as Asia and Western Europe
Confidential inVentiv Clinical Solutions 2008
The Changing Outsourcing Paradigm
Vendor Viewpoint CROs are being called upon to help fill the void as R&D
expands and industry downsizes
Calls for the development of flexible service solutions to fit the varying needs from Biotech to Big Pharma, from local to off-shore
Shift in outsourcing model from service to strategic partnership allows for closer collaboration, development of product knowledge, and sharing of risk
Flexible Outsourcing Solutions
Flexibility is key to meeting outsourcing needs as it is not one size fits all
Alternatives in outsourcing provide appropriate structures and levels of control to meet the situation
Service offerings tailored to meet the sponsor’s needs allowing for variability both across and within organizations
Finding the right solution must include enhancing quality and efficiencies
The Flexibility Continuum
Maintaining desired level of control withsignificant flexibility and cost-effectiveness
Maximum Sponsor Control
Executed Internally
Minimum Sponsor Control
Fully Outsourced
Staff Augmentation
Functional Services
Resource Teams
Full-Service Solutions
Staff AugmentationGreat solution for:Short-term resource needs
Allows for direct contact with Sponsor staff
Sponsors select individuals with desired experience/skill level
Can easily shift assignments to aligning resources with changing priorities
Utilize Sponsor systems and process for seamless integration
Collaboration, communication and team building opportunities enhanced by close proximity
Not well suited for: Companies with minimal infrastructure or long-term projects
Requires on-site support by sponsor and more investment to provide direction, systems and processes
Co-employment rules contribute to frequent turnover leading to lost time due to replacement of staff (hiring, training, loss of knowledge base, team disruption, etc)
Limited accountability for vendor once placement made puts burden on sponsor to oversee and manage
Staff Augmentation
Examples of Staff Augmentation Hire statistical programmers to help support
analysis and reporting of clinical trial data. Bring on a specialist in therapeutic area to aid
with trial design. Hire programming staff to build EDC applications
in the sponsor’s environment.
Dedicated Resource GroupsGreat solution for:Medium to long-term resource needs
Sponsors have input into selection process defining desired experience/skill level
Sponsor and vendor share management and accountability
Flexible, rapid deployment of resources based on sponsor priorities
Utilize the same process and systems for seamless integration with work done in-house
Collaboration, communication and team building opportunities
Not well suited for:Emerging companies where workload or funding may impair full team utilization
Full resource utilization requires upfront planning and collaboration to be successful- adjustments may need to be made for changes in workload (ramp-up or downsize)
Fluctuations in workload can result in unstable work environment which may affect retention
Dedicated Resource Groups
Examples of Dedicated Resource Groups Remote group of statisticians and statistical
programmers to support reporting of Phase III trials along with preparation of ISS/ISE for submission.
Group of Statisticians that have long-term experience with product and clinical trial knowledge
Data management team hired to support data validation and locking in sponsor’s system.
Functional Outsourcing ModelsGreat solution for:Individual project needs
Strategic outsource planning by functional area heads yields efficient dissemination of work
Meets many project needs without staffing or system challenges
Allows for selection of best in class functional vendors
Reduces the load on the sponsor
Vendor management is accountable for delivery of specific projects adhering to metrics and timelines in an efficient manner
Not well suited for:High priority projects or highly specialized indications requiring in-house knowledge
Reduced control over process requires confidence in vendor quality systems and final product
Members of clinical project team may be located at sponsor and various vendors making communication more challenging
May impact in-house knowledge of studies and results that are necessary for support of products and regulatory submissions
Functional Outsourcing Models
Examples of Functional Outsourcing Protocol developed in-house and then outsource
SAP and statistical reporting Statistical expertise provided for protocol and SAP
for an adaptive trial Outsource support of Data Safety Monitoring Board
to include data analysis, reporting and consultation Vendor develops EDC system, DMP and executes
data management activities delivering final clean locked database for a given study
Full Service ModelsGreat solution for:Sponsor wants to only provide oversight. (May not have in house staff, be lower priority project, or be more efficient model for delivery)
Sponsor provides oversight at a high level with minimal resource commitment and lower overhead
Vendor coordinates all aspects of the clinical trial including hand-offs between groups, risk mitigation and issue resolution
Places the balance of the project team on the vendor side which enhances collaboration
Selection of vendor with specific therapeutic expertise or access to desired resources or patient populations
Not suited for:High priority projects or highly specialized indications which require in-house knowledge and coordination
Reduced control over process requires confidence in vendor quality systems and final product.
May impact in-house knowledge of studies and results that are necessary for support of products and regulatory submissions
Integration issues may arise if submission projects are executed at various vendors using variable standards and systems
Vendors who specialize in some areas but do not have cross-functional delivery strength
Full Service Models
Examples of Full Service Models
Delivery of a clinical trial from protocol development to execution to delivery of results and submission ready information
Support product development for a small biotech company including regulatory advice, research planning and clinical trial execution
Support Phase I program for emerging biotech company with first in man, dose escalation and food effect studies.
Shift from Service to Strategic Partnership
Paradigm shift from fee for service to a more strategic and collaborative relationship with a long-term focus– Sponsors are selecting a few trusted vendors and forming
partnerships and alliances – Strategic partnership allows for a deeper level of communication
and collaboration (communication on all levels with governance and oversight at executive level)
– Increased efficiencies and decreased costs result from increased stable work volume, gain in product knowledge and long-term execution to sponsor standards
Shift from Service to Strategic Partnership
Re-engineering of process from in-house execution to oversight and management of vendors– Shift in skill sets needed by in-house staff from technical expertise
to project oversight demanding a higher level of communication and coordination
– Increase in shared standards, processes and systems for ease of integration
– Executive commitment and governance board to provide oversight and expedite decision making
Shared risk and rewards as product development strategies and up front clinical trial planning allow vendor to maximize deployment of resources and streamline execution
Shift from Service to Strategic Partnership
Traditional Outsourcing Paradigm
Staff Augmentation
Functional Outsourcing
Full Service Outsourcing
Modern Partnership-Based Models
Dedicated Resource Teams
Full Functional Outsourcing
Strategic Alliances
Factors in a Successful Partnership
Pairing of sponsors and vendors who are in alignment on objectives and have a strong commitment to a successful outcome
Building effective lines of communication – Put governance and oversight mechanisms in place– Sufficient resources on both sides to effectively collaborate and
manage the relationship
Strategic planning will lead to rapid and efficient resource deployment and streamline execution
Mutual investment and risk sharing from both partners leads to a well-balanced relationship
Confidential inVentiv Clinical Solutions 2008
Dedicated Resource GroupsThe Challenge:Women’s health study with large back-log of CRFs – now a major company priority
Backlog of 200,000 CRFs
Monthly influx of 29,000 CRFs
CRFs needed to indexed, scanned and entered
Entered data needed to validated, DCFs sent, and queries resolved
Delivery of cleaned database ready for lock in sponsor system
Aggressive project timeline due to shift in sponsor priorities
The Solution:Assemble a Dedicated Data Management using a partnership vendor
Partnership already established with the vendor trained on sponsor data management systems and processes
Assemble a dedicated team of 18 data management professionals and train them on the project
Improve metrics and reduce turnaround time for data entry and cleaning
Dedicated Resource Groups
Outcome Average turnaround time from receipt of CRF to
validation was reduced to 48 hours Weekly performance metric expectations established
– Expectations were exceeded as gained familiarity– Sponsor Expectations: 80-100 visits/wk cleaned per person – Actual Performance: 110-120 visits/wk cleaned per person – Average Total Cleaned: 1500 visits/week
Database cleaned 2 days ahead of schedule Results: Database lock met aggressive timeline
allowing sponsor access to trial results sooner.
Full Functional OutsourcingThe Challenge:Company wants to fully outsource all of it’s statistical programming activities
Flexible support needed across multiple therapeutic areas
Working with multiple vendors increases sponsor oversight and presents difficulty in maintaining standards
Develop efficiencies in creating analysis datasets based on CDISC and ADaM requirements
Team based staff on sponsor side results in downtime for some staff while others are overwhelmed
The Solution:Establish a partnership that allows for the full support of statistical programming activities
Establish Governance board along with Alliance Manager to expedite communication and decision making
Single vendor manages across projects to deliver against agreed upon timelines and standards
Manage allocation of resources to correspond with sponsor priorities
Vendor has direct secure access into sponsor system
Full Functional Outsourcing
Outcome
Higher level of Collaboration – Executive level collaboration on resource planning and milestone
agreement across protocols– Team Leads have direct access to sponsor statisticians and play a
consultative role as they develop product knowledge– Single vendor responsible for oversight of other vendors (e.g.
programming off-shored to India) Performance Metrics and increased resource utilization
– Rapid delivery of key statistical results (24-48 hrs post-DBL)– Resources can be optimally deployed as priorities change– Detailed level of standardization results in maximum efficiency
Seamless delivery as statistical analysis and reports are placed directly into sponsor’s system
Confidential inVentiv Clinical Solutions 2008
Strategic AllianceThe Challenge:Small pharma company has limited in-house staff and infra-structure to take their product to market
Sponsor expertise lies with the product while needing support to bring it to market
In-house staff limited to executive level requiring systems and resources to design and execute clinical trials
Seeking partner with knowledge of regulatory requirements and clinical trial design and execution
The Solution:Establish a partnership that allows for the full support of clinical development
Partner with a vendor that specializes in supporting small company regulatory submissions
Establish strong lines of communication and governance
Provide consultative expertise on submission strategies and support regulatory interactions
Clinical trial execution and delivery provided according to agreed upon timelines
Strategic Alliance
Outcome
Strategic Planning and consultation from vendor– Collaborate on the product development and submission plan– Recommend 505 B2 submission route saving time/money– Produce publications & manuscripts based on product
knowledge Performance Metrics and increased resource utilization
– Flexibility to provide resources to compliment in-house expertise– Ramp-up or down to maximize resource utilization– SOPs, systems and standards are already in place – Efficiencies gained across protocols with re-useable tools
Delivery of 6 Phase I-II trials and FDA support
Confidential inVentiv Clinical Solutions 2008
Summary
Pharma and biotech industry must find smarter ways to get their products to market.
CROs need to provide a tactical blend of options to meet the changing needs of their customers
Both sides must be creative in finding the best, most efficient, cost effective outsourcing solution
Need for long-term solutions has led to strategic partnerships which can benefit both partners through shared risks and rewards
Confidential inVentiv Clinical Solutions 2008
Summary
Benefits of long-term Strategic Partnerships:– Decreased costs due to predictable long-term work
volume maximizing resource utilization and allowing for process efficiencies to be realized
– Increased quality as standardized, repeatable processes are employed and product knowledge expands
– Deeper lines of communication across multiple levels including highest levels builds long-term trust and improves collaboration
Confidential inVentiv Clinical Solutions 2008
Questions & Discussion