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ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSIONENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSIONENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
TOPRA MSc Module 10
Outsourcing RA to a CRO –What are the Benefits & the Challenges ?
A presentation by Peter Embley, Associate Director, PPD
l Understand the Key Definitions for Outsourcing
l Identify Regulatory Activities which may be Outsourced
l Understand the Evolution and Benefits of Outsourcing
l Identify the Challenges of Outsourcing
l Ensuring Successful Collaboration with a Partner
Learning Outcomes
l Key Definitions for Outsourcing
l Outsourced Regulatory Activities
l Evolution and Opportunities in Outsourcing
l Ensuring Successful Collaboration in Partnerships and Mitigating the Risks
In this presentation we will cover
Key Definitions for Outsourcing
Sponsor Contract Giver. Individual or entity who organizes and is committed to the development of a product, program, or project
Vendor Contract Acceptor. Individual or entity who provides a specified service for the development of a Sponsor’s product, program, or project
Clinical Research Organisation (CRO)
An organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis
Lifecycle Management Or Product Lifecycle management. Ensures Regulatory Compliance throughout a Product Lifecycle
Full Service Provision Service offering with the provision of two or more functions such as; Regulatory, Clinical Trial Management, Safety, Biostats etc.
Budget: Unit Based Expenditure incurred in producing one unit of a good or service, usually normalised as an average cost
Budget Time & Materials An arrangement under which a vendor is paid on the basis of (1) actual cost of direct labour, usually at specified hourly rates, (2) actual cost of materials and equipment usage
Budget: Full Time Equivalent(FTE)
The ratio of the total number of paid hours during a period (part time, full time, contracted) by the number of working hours in that period Mondays through FridaysThe ratio units are FTE units or equivalent employees working full-time. In other words, one FTE is equivalent to one employee working full-time
Outsourced Regulatory Activities
* Full Service Provision
* Full Lifecycle Management
* Product Lifecycle Management
* Publishing
* Clinical Trial Applications/Approvals* Regulatory Authoring* Consulting
Types of Vendor
1. Clinical Research Organisations– Global or Regional coverage, depending on the size of organisation. Offer additional services to
Regulatory such as Clinical Trial Management, Contract Laboratory & Manufacturing Services, Safety Signal Detection etc.
2. Regulatory Consultancies– Global or Regional coverage, depending on the size of the organisation. May offer some additional
(limited) services to Regulatory
3. Consultants– Regional or country specific services, usually a single FTE offering specific consultant services. May
offer limited management consultancy services and Project Management
4. Management Consultants– Global or Regional coverage, depending on the size of organisation. Review and advise on existing
business process operations to enhance performance. Also offer Project Management services
Outsourced Regulatory Activities
Perfect Storm
Evolution and Opportunities in Outsourcing
MAA SubmissionsIncreasing Maintenance duties
Reducing Operating costs
A drive to change the Pharma Business Model
The Evolution of FSP Services
Provider only
delivers resources
Inputs andFTE-based contracts
Transition between CRO
and FSP models
Client management of function
Outputs based
contracts
Provider innovation encouraged
Heavy technology
focus
Time and Experience
Deg
ree
of
Sop
his
tica
tion
Traditional FSP Model Next Generation FSP Model
Next Generation FSP
– Traditional FSP services include monitoring, biometrics, and safety
– Market demand is driving newer solutions including medical writing, site activation and regulatory affairs
– Combine the right mix of knowledge capital with productive task-based labor
– Variety of contract types based on service and client needs
What Differentiates this Model?
1. Core versus Non-Core– Allows client to focus on core strengths and skills– Provides a flexible and scaled model to meet labeling compliance needs
2. Focus on Deliverables and Services– Standards with innovative solutions– Quality focus– Long term productivity goals– Predictable cost structure
3. Focus on Innovation– Leverages technology and process improvement by both the client and the
service provider, e.g. Information management, reporting, and transparency
What does an outsourced partner offer?
1. Cost Efficiencies– Reduction in FTE overheads, headcount, infrastructure, etc.– Majority of activities are performed in a cost-effective location– High volume activities ensure residual expertise and higher output
2. Global Coverage– Local offices– Strong and expansive regulatory network– Residual Local Expertise
3. Strategic & Regulatory Intelligence– Global strategic expertise within central offices– Global Regulatory Intelligence
4. Workflow Management– Adaptable & Flexible Expertise– ‘Virtual’ Regulatory department
Evolution and Opportunities in Outsourcing
Common Pharma concerns:
1. ‘Turnover is too high’– Turnover is relatively higher, but CROs are robust contingency plans to mitigate Risk. Customer
Service is key
2. ‘CROs often shift their staff around projects’– Sponsor retains the right to ensure particular staff remain on a project– Differentiated management resource principles, more flexibility
3. Will my Project/Programme receive the due attention?– Customer Service is paramount to the CRO, therefore a Project of any size is given due attention
4. Do they have enough experience?– Transparent Learning Management System captures experience– Opportunity to request CVs remains throughout the Selection Process. Interviews are also an
option
Evolution and Opportunities in Outsourcing
Partnerships
● Global or Regional coverage, depending on the size of organisation. Offer additional services to Regulatory such as Clinical Trial Management, Contract Laboratory & Manufacturing Services, Safety Signal Detection etc.
● Framework Agreement, provides incentives such as discounts, performance bonuses
● Greater understanding of Sponsor/Vendor company profile, operations
● Sponsor retains ability to select other vendors for new projects
Evolution and Opportunities in Outsourcing
Key Performance Indicators
● When are they applied?– Late transition phase through to operational
● Where are they applied?– Accuracy of Submission Planning & Execution– Submission Quality
● What can they add?– Pre-agreed Quality specification– Ability to increase Standards, Performance and Output
Evolution and Opportunities in Outsourcing
Ensuring Successful Collaboration and Mitigating the Risk
Case Study – Pharma Company
● Established Lifecycle Management for small molecule & biotech Portfolio
● Global Registrations
● Scope of Work;– Submission Management– Dossier Compilation, including CMC Authoring
Ensuring Successful Collaboration and Mitigating the RiskSelection Process
Request For Information
•Background Information i.e. Metrics, Company Profile, Experience
Request For Proposal
•Detailed Plan based on SOW, Budget
Bid Defence Meeting
•Detailed Presentation
Pre-Contract Agreement
•Contract to manage Transition Phase
Transition Phase
•Workstreams to transfer over Product/Process Knowledge etc.
Operational Phase
Close-Out
AWARD
• Performance Review • Review Scope of Work > initiate Contract Modifications
Ensuring Successful Collaboration and Mitigating the Risk
Case Study – EU Pharma Company
● Setting sponsor expectations for;– Timelines– Transition– Governance/Oversight– Performance– Scope of Work– Contingencies & Indemnity
Expectations must be clear and transparent to Sponsor & Vendor
Ensuring Successful Collaboration and Mitigating the Risk
Defining Vendor Selection Criteria
1. Partnership– SOW demands an intrinsic relationship between Sponsor & Vendor– Significant commitment on both sides
2. Experience– Specific submission experience – Vendor should have a global reach– Opportunity to ‘pressure test’ residual experience i.e. Interview, Audit, etc.
3. Resource– Detailed Recruitment Plan
4. IT Infrastructure– Identified system(s) to be used by the Vendor– Ensure licenses are in place to grant access to the system(s), with appropriate permission levels
granted to perform defined tasks– Ensure system training is accessible for Vendor location(s) and available – IT architecture to support consistent network connectivity (e.g. Citrix)– Gap Analysis to ensure all systems are available to SOW e.g. Submission Workplanning/Tracking
Responsibility Assignment Matrix
● What are they?– describes the participation by various roles in completing tasks or deliverables for a project or
business process. It is especially useful in clarifying roles and responsibilities in cross-functional/departmental projects and processes
Responsible Those who do the work to achieve the task. There is at least one role with aparticipation type of responsible, although others can be delegated to assist inthe work required
Accountable (also approver or final approving authority) The one ultimately answerable for thecorrect and thorough completion of the deliverable or task, and the one whodelegates the work to those responsible
Consulted (sometimes counsel) Those whose opinions are sought, typically subject matterexperts and with whom there is two-way communication
Informed Those who are kept up-to-date on progress, often only on completion of the taskor deliverable; and with whom there is just one-way communication
● What can they add?– Transparent accountability between Sponsor and Vendor
● When are they applied?– During Transition Phase
Evolution and Opportunities in Outsourcing
Ensuring Successful Collaboration and Mitigating the Risk
Defining Vendor Selection Criteria
6. Transition Plan
Governance: ‘Project sponsors’ providing executive direction and support where necessary
Legal: Responsible for the construction and agreement of a pre-contractual agreement (if necessary) and the full contract
Project Management: Reporting to Governance, responsible for all activities, ensuring Transition Plan milestones are met
Operations: Depending on the Scope of Work, initially responsible for organising the transfer of specific product knowledge, ensuring process workflows (i.e. SOPs, WPDs) are tangible and agreeable between both parties, a training programme is delivered and IT architecture arranged to ensure required system performance
Recruitment: Develops and executes the Recruitment Plan
Risk Escalation and Governance
ExecutiveTeam
Strategic Support
Management TeamMonthly Review MeetingsSenior Project Oversight
Operational TeamWeekly Team Meetings
Implementation and Ongoing Oversight
Ensuring Successful Collaboration and Mitigating the Risk
Case Study – EU Pharma Company
● Prequalification/Audits– Ensure Vendor credentials/experience
● WorkPlanning/Tracking– Critical piece– Developed during Transition Phase– Required significant consideration
l The key definitions for Outsourcing
l Regulatory Activities which may be Outsourced
l The evolution and benefits of Outsourcing
l Discussed the challenges of Outsourcing
l Case study ensuring successful collaboration with a partner
In this presentation we covered
l K Hammeke. ‘2014 Trends In Strategic Outsourcing – Changes In The Qualities That DriveOutsourcing Partner Selection’, Life Science Leader, Jan 2014; 16-18.
l Outsourcing Regulatory Life Cycle Management, An Efficient New Model Meets IncreasingGlobal Demands. October 2013. Available at: http://www.ppdi.com
l S Bassion. ‘Success and Failure in the Sponsor-Vendor Partnership’, Pharma Focus Asia.Available at: http://www.pharmafocusasia.com/knowledge_bank/articles/sponsor-vendor_partnership.htm
l Partnering with the right CRO is a winning strategy for companies big and small. Sept 2013.Available at: http://www.ddw-online.com/business/p216817-partnering-with-the-right-cro-is-a-winning-strategy-for-companies-big-and-small-fall-13.html
l K Hart, C Newton, N Gillet, K Somberg, T Gladwell, S Basu. ’What to Consider When Lookingfor a CRO’, Genetic Engineering & Biotech News. Available at:http://www.genengnews.com/gen-articles/what-to-consider-when-looking-for-a-cro/4610
l A Guide to the Project Management Body of Knowledge (PMBOK Guide). PMI StandardsCommittee, Project Management Institute. 2010. ISBN 1-933890-66-5
l Working with Contract Research Organisations. April 2008. Available at:http://www.alnmag.com/articles/2008/04/working-contract-research-organizations
Recommended References
QUESTIONS?
