The Changing Outsourcing Paradigm from Service to Strategic Partnership: The Vendor Viewpoint

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




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



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


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


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


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


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


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


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


Questions & Discussion

Documents

The Changing Outsourcing Paradigm from Service to Strategic Partnership: The Vendor Viewpoint