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project services
                 Flexible. Practical. Technical.




Project services                                                      Science. We	leverage	more	than	44	years	of	scientific	and	clinical	
                                                                      research workforce expertise to support critical-path studies
Project Services is a dynamic service from Kelly® that provides       across a range of therapeutic areas within our pharmaceutical,
clients across the globe with a practical, technically driven         biotech, and medical device clients who are leading the efforts to
approach to project-based endeavors.                                  improve the quality of life across the globe.

Rely on a partner you can to trust for project services including:    Information technology. Our	longstanding	experience	in	
•	 Scalable	project	development	and	deployment                        delivering technology workforce solutions helps clients drive
•	 Customized	PMO	integration	solutions                               innovation and cost reduction across IT disciplines including
•	 Global	talent	delivery                                             Applications Development & Integration, Software QA & Testing,
•	 Targeted	industry-specific	expertise                               Data Warehousing & Business Intelligence, Data Storage,
•	 Commercially	viable	project	innovation                             Infrastructure Support and Network Engineering.

As a leading workforce solutions provider, Kelly has industry-
specific	project	expertise	across	complementary	verticals:

Engineering. Serving the engineering sector since 1965, we                               PMO integration
engage best-in-class project management methodologies,                                   Are you lacking best-in-class project
support systems, and subject matter experts to provide our clients
                                                                                         management methodologies, processes,
with a high-quality, focused approach to project initiatives within
                                                                                         and supporting tools? We’ll assess your
commissioning, FDA validation and compliance, oil and energy,
mining and minerals, and environmental management.
                                                                                         gaps,	develop	a	customized	PMO	platform	
                                                                                         for	your	organization,	and	manage	the	
                                                                                         entire program until maturity.




kellyservices.com
Continuum of service                                                     Project services life cycle
Kelly	project	managers	utilize	best-in-class	methodology	
to provide a complete continuum of service for our clients,
         Pro
             jec
while keepingt a constant eye on quality of service, the triple               Defining       Planning       Implementing
                 Manage
                        ment Methodology
constraint, and overall business objectives.

                                                            ces    ses
                                                      d Pro
                                     Business Plans an
                                                                                            Closing        Monitoring
              Qu
                    ality
                            of Service
                                         (QoS) Plans

                                                                         Take a look at what you get within your timeframe and budget
                                                                         with project services from Kelly:
     Pro                                                                 •	 Project	scoping Planning
           ject                                                             Defining                        Implementing
                M   anagement Methodology
                                                                         •	 Feasibility	studies
                                                                         •	 PMO	integration
                                                            sses         •	 Needs	assessments
                                                   d   Proce
                                  Business Plans an                      •	 Gap	analysis
                                                                         •	 Project	design Closing         Monitoring
        Qu
             ality                                                       •	 Change	control
                     of Service
                                   (QoS) Plans
                                                                         •	 Talent	delivery
                                                                         •	 Process	improvement
                                                                         •	 Quality	reviews
                                                                         •	 Knowledge	transfer
                                                                         •	 Lessons	learned
                                                                         •	 Training	updates
                                                                         •	 Close-out	reports

            The Kelly Advantage
FDA liaison activities
Need assistance in interfacing with the
FDA?	Our	regulatory	experts	can	assist	in	
developing	your	firm’s	response	to	483s	
and	Warning	Letters,	as	well	as	creating	
comprehensive corrective action programs
to	mitigate	material	deficiencies.




   FDA validation and compliance                                       Clinical research and development
   To promote business continuity and compliance with regulatory       We provide full service capabilities in biometrics, data
   guidelines, we offer a comprehensive line of validation,            management,	and	clinical	operations.	Our	team	of	technical	and	
   compliance, and quality services to our life sciences clients.      scientific	experts	brings	the	knowledge	and	experience	necessary	
   Our	team	of	subject	matter	experts	is	well	versed	on	the	most	      to assist research and development efforts within all phases:
   up-to-date guidance from the FDA and can bring a practical          •	 Pre-clinical	and	animal
   understanding of interpretations required to mitigate risk          •	 Phases	I,	II,	III
   enterprise-wide.                                                    •	 Phase	IV	and	post-marketing
                                                                       •	 PK/PD
   Capabilities cover the full range:	21	CFR	Part	11,	Part	210/211,	
   GAMP5,	Part	320/820,	Part	58                                        Biometrics
                                                                       We have experienced biostatisticians and statistical programmers
   Across the entire spectrum: CSV,	GMP,	GLP,	GCP,	GDP,	GxP,	ICH,	     supporting	studies	targeted	toward	NDA,	BLA/	PLA,	and	MPA.	
   CQV,	equipment/utilities/facilities,	process/cleaning/packaging     We provide:
                                                                       •	 Statistical	design	and	protocol	development
   Engineering design qualification services:                          •	 Statistical	analysis	plans	(SAPs)
   •	 Design	qualification                                             •	 Statistical	reports	and	publication	design/support
   •	 	 onducting	vendor	audits,	FAT	(factory	acceptance	testing),	
      C                                                                •	 Statistical	programming	(SAS®)	and	analysis
      and	SAT	(site	acceptance	testing)                                •	 Summary	tables,	patient	listings,	and	graphs
   •	 Software	developer	assessment                                    •	 Integrated	summaries	of	safety	and	efficacy	(ISS/ISE)
   •	 	 pecifications	–	user	requirements,	functional	requirements,	
      S                                                                •	 Sample	size	and	randomization
      and detailed design
   •	 Commissioning                                                    Clinical data management
                                                                       Our	experts	have	significant	experience	in	the	following	areas:
                                                                       •	 CRF	design	and	printing
                                                                       •	 Database	installs/upgrades
                                                                       •	 Medical	coding
                                                                       •	 Data	entry	and	validation
                                                                       •	 Data	coordination	and	integrity
                                                                       •	 QC	and	edit	checks
                                                                       •	 Electronic	data	capture	(EDC)
                                                                       •	 Electronic	submissions
                                                                       •	 Oracle®	Clinical	and	ClintrialTM
IT solutions
                                                                                         Need a partner who understands your business
                                                                                         environment?	Kelly	supports	more	than	80	
                                                                                         percent of the Information Week	500	companies.	
                                                                                         around	the	globe.	Our	IT	talent	pool	is	highly	
                                                                                         educated, mobile, and well versed in the latest
                                                                                         systems, software, and hardware.




Oil and natural gas                                                   Information technology
Exploration and production                                            Kelly has been on the leading edge of our client’s technology
Our	highly	skilled	exploration	and	production	teams	focus	on	         innovation and talent management for more than 45 years.
delivering upstream production support—onshore and offshore,          Combining	world-class	project	methodology	with	our	wide	pool	
domestically and internationally—to the world’s largest energy        of technical subject matter experts, we’re able to deliver practical
firms.	Our	capabilities	cover	the	wide	spectrum.                      solutions to some of the industry’s most complex IT challenges.

Field service and operations                                          We employ a collaborative approach with our clients by engaging
•	 DSMs/Superintendents	for	active	rigs	worldwide                     in a three-step process to ensure expectations are always set and
•	 Degreed	geologists                                                 deliverables are consistently met:
•	 Health,	safety,	environmental	(HSE)                                •	 Identifying	and	understanding	your	business	drivers	and	impacts
•	 Well	planners	(directional	and	straight-hole)                      •	 Developing	and	selecting	the	most	cost-effective	delivery	models
•	 Degreed	MWD	and	LWD	engineers                                      •	 	 stablishing	and	monitoring	project	quality	standards	and	
                                                                         E
•	 Reservoir	engineers                                                   oversight perimeters

Industrial mining                                                     Throughout the decades, we’ve accumulated the functional
Clients	turn	to	Kelly	for	industry-defined	solutions	to	help	drive	   and technical knowledge required to drive development
productivity	and	profitability.		Our	consultants	have	accumulated	    life cycles, improve quality and reliability, accelerate project
best-in-class expertise across the globe supporting large capital     schedules, and enhance our customer’s overall ability to stay
projects from exploration to mine performance management.             competitive and innovative.

Deploying a diverse and experienced team of personnel, we’re          Selected areas of expertise include:
able to address workforce shortages, productivity issues, and         •	 	 loud	Computing
                                                                         C
technology challenges to assist our clients in producing optimum      •	 	 irtual	Networks
                                                                         V
operational performance.                                              •	 	 ata	Warehouse	&	Business	Intelligence
                                                                         D
                                                                      •	 	 nterprise	Systems	Integration	and	Customization
                                                                         E
Worldwide capabilities within:                                        •	 	 eb-based	Technologies
                                                                         W
•	 Pre-feasibility,	feasibility,	conceptual,	and	scoping	studies      •	 	 ealth	Informatics	
                                                                         H
•	 Mining	engineering	services
•	 HAZOP	assessments	and	studies                                      Environmental management
•	 Mining	information	management	systems                              Kelly understands the importance of conserving and restoring
                                                                      our natural resources, instituting sustainable communities, and
                                                                      decreasing	our	carbon	footprints.	Our	engineers	and	scientists	
                                                                      support leading efforts within the environmental industry to assess
                                                                      the impact of human activity and drive innovative, cost-effective,
                                                                      and practical solutions to improve our daily lives.

                                                                      Specific	areas	of	project	focus	include:
                                                                      •	 Environmental	assessments	(EAs)
                                                                      •	 Environmental	impact	assessments	(EIAs)
                                                                      •	 Natural	Environmental	Policy	Act	(NEPA)	compliance
                                                                      •	 Air	quality	compliance
                                                                      •	 Geotechnical	engineering
                                                                      •	 Water/Waste	water	management
                                                                      •	 Geographic	information	systems	(GIS)	specialists
Kelly Services global
infrastructure

                         AmErICAS                                              EmEA               ApAC
                                                                          Europe,	Middle	East,   Asia-Pacific                   Temporary
                                                                               and Africa                                Temporary to Hire
                                                                                                                                Direct Hire
                                                                                                                       On-site Management
                                                                                                                            Payroll Services

                                                                                                                         Areas of Expertise
                                                                                                                                Automotive
                                                                                                                             Contact Center
                                                                                                                           Creative Services
                                                                                                                                  Education
                                                                                                                        Electronic Assembly
                                                                                                                                Engineering
                                                                                                                    Finance and Accounting
                                                                                                                                Government
                                                                                                                                 Healthcare
                                                                                                                                   Industrial
                                                                                                                    Information Technology
                                                                                                                                         Law
                                                                                                                                  Marketing
                                                                                                                                      Office
                                                                                                                                     Science

                                                                                                                           project Services
                                                                                                                              Project Teams
                                                                                                                       Project Management
                                                                                                                           PMO Integration
                                                                                                                       SOW-based Services

                                                                                                                 Outsourcing & Consulting
                                                                                                                                Solutions
                                                                                                                      Recruitment Process
                                                                                                                              Outsourcing
                                                                                                                           Business Process
                                                                                                                               Outsourcing
                                                                                                                      Contingent Workforce
For more information, contact Kelly Services today.                                                                           Outsourcing
Daniel rhodes                                                                                                             Human Resources
phone :: 760.458.4505                                                                                                          Consulting
E-mail :: daniel.rhodes@kellyservices.com                                                                               Career Transition &
                                                                                                                Organizational Effectiveness
michael ruchman                                                                                                            Executive Search
phone :: 858.232.7110
E-mail :: michael.ruchman@kellyservices.com




kellyservices.com
All trademarks are property of their respective owners.
An	Equal	Opportunity	Employer		©	2010	Kelly	Services,	Inc.	V0202		R5/10

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V0202 Project Services

  • 1. project services Flexible. Practical. Technical. Project services Science. We leverage more than 44 years of scientific and clinical research workforce expertise to support critical-path studies Project Services is a dynamic service from Kelly® that provides across a range of therapeutic areas within our pharmaceutical, clients across the globe with a practical, technically driven biotech, and medical device clients who are leading the efforts to approach to project-based endeavors. improve the quality of life across the globe. Rely on a partner you can to trust for project services including: Information technology. Our longstanding experience in • Scalable project development and deployment delivering technology workforce solutions helps clients drive • Customized PMO integration solutions innovation and cost reduction across IT disciplines including • Global talent delivery Applications Development & Integration, Software QA & Testing, • Targeted industry-specific expertise Data Warehousing & Business Intelligence, Data Storage, • Commercially viable project innovation Infrastructure Support and Network Engineering. As a leading workforce solutions provider, Kelly has industry- specific project expertise across complementary verticals: Engineering. Serving the engineering sector since 1965, we PMO integration engage best-in-class project management methodologies, Are you lacking best-in-class project support systems, and subject matter experts to provide our clients management methodologies, processes, with a high-quality, focused approach to project initiatives within and supporting tools? We’ll assess your commissioning, FDA validation and compliance, oil and energy, mining and minerals, and environmental management. gaps, develop a customized PMO platform for your organization, and manage the entire program until maturity. kellyservices.com
  • 2. Continuum of service Project services life cycle Kelly project managers utilize best-in-class methodology to provide a complete continuum of service for our clients, Pro jec while keepingt a constant eye on quality of service, the triple Defining Planning Implementing Manage ment Methodology constraint, and overall business objectives. ces ses d Pro Business Plans an Closing Monitoring Qu ality of Service (QoS) Plans Take a look at what you get within your timeframe and budget with project services from Kelly: Pro • Project scoping Planning ject Defining Implementing M anagement Methodology • Feasibility studies • PMO integration sses • Needs assessments d Proce Business Plans an • Gap analysis • Project design Closing Monitoring Qu ality • Change control of Service (QoS) Plans • Talent delivery • Process improvement • Quality reviews • Knowledge transfer • Lessons learned • Training updates • Close-out reports The Kelly Advantage
  • 3. FDA liaison activities Need assistance in interfacing with the FDA? Our regulatory experts can assist in developing your firm’s response to 483s and Warning Letters, as well as creating comprehensive corrective action programs to mitigate material deficiencies. FDA validation and compliance Clinical research and development To promote business continuity and compliance with regulatory We provide full service capabilities in biometrics, data guidelines, we offer a comprehensive line of validation, management, and clinical operations. Our team of technical and compliance, and quality services to our life sciences clients. scientific experts brings the knowledge and experience necessary Our team of subject matter experts is well versed on the most to assist research and development efforts within all phases: up-to-date guidance from the FDA and can bring a practical • Pre-clinical and animal understanding of interpretations required to mitigate risk • Phases I, II, III enterprise-wide. • Phase IV and post-marketing • PK/PD Capabilities cover the full range: 21 CFR Part 11, Part 210/211, GAMP5, Part 320/820, Part 58 Biometrics We have experienced biostatisticians and statistical programmers Across the entire spectrum: CSV, GMP, GLP, GCP, GDP, GxP, ICH, supporting studies targeted toward NDA, BLA/ PLA, and MPA. CQV, equipment/utilities/facilities, process/cleaning/packaging We provide: • Statistical design and protocol development Engineering design qualification services: • Statistical analysis plans (SAPs) • Design qualification • Statistical reports and publication design/support • onducting vendor audits, FAT (factory acceptance testing), C • Statistical programming (SAS®) and analysis and SAT (site acceptance testing) • Summary tables, patient listings, and graphs • Software developer assessment • Integrated summaries of safety and efficacy (ISS/ISE) • pecifications – user requirements, functional requirements, S • Sample size and randomization and detailed design • Commissioning Clinical data management Our experts have significant experience in the following areas: • CRF design and printing • Database installs/upgrades • Medical coding • Data entry and validation • Data coordination and integrity • QC and edit checks • Electronic data capture (EDC) • Electronic submissions • Oracle® Clinical and ClintrialTM
  • 4. IT solutions Need a partner who understands your business environment? Kelly supports more than 80 percent of the Information Week 500 companies. around the globe. Our IT talent pool is highly educated, mobile, and well versed in the latest systems, software, and hardware. Oil and natural gas Information technology Exploration and production Kelly has been on the leading edge of our client’s technology Our highly skilled exploration and production teams focus on innovation and talent management for more than 45 years. delivering upstream production support—onshore and offshore, Combining world-class project methodology with our wide pool domestically and internationally—to the world’s largest energy of technical subject matter experts, we’re able to deliver practical firms. Our capabilities cover the wide spectrum. solutions to some of the industry’s most complex IT challenges. Field service and operations We employ a collaborative approach with our clients by engaging • DSMs/Superintendents for active rigs worldwide in a three-step process to ensure expectations are always set and • Degreed geologists deliverables are consistently met: • Health, safety, environmental (HSE) • Identifying and understanding your business drivers and impacts • Well planners (directional and straight-hole) • Developing and selecting the most cost-effective delivery models • Degreed MWD and LWD engineers • stablishing and monitoring project quality standards and E • Reservoir engineers oversight perimeters Industrial mining Throughout the decades, we’ve accumulated the functional Clients turn to Kelly for industry-defined solutions to help drive and technical knowledge required to drive development productivity and profitability. Our consultants have accumulated life cycles, improve quality and reliability, accelerate project best-in-class expertise across the globe supporting large capital schedules, and enhance our customer’s overall ability to stay projects from exploration to mine performance management. competitive and innovative. Deploying a diverse and experienced team of personnel, we’re Selected areas of expertise include: able to address workforce shortages, productivity issues, and • loud Computing C technology challenges to assist our clients in producing optimum • irtual Networks V operational performance. • ata Warehouse & Business Intelligence D • nterprise Systems Integration and Customization E Worldwide capabilities within: • eb-based Technologies W • Pre-feasibility, feasibility, conceptual, and scoping studies • ealth Informatics H • Mining engineering services • HAZOP assessments and studies Environmental management • Mining information management systems Kelly understands the importance of conserving and restoring our natural resources, instituting sustainable communities, and decreasing our carbon footprints. Our engineers and scientists support leading efforts within the environmental industry to assess the impact of human activity and drive innovative, cost-effective, and practical solutions to improve our daily lives. Specific areas of project focus include: • Environmental assessments (EAs) • Environmental impact assessments (EIAs) • Natural Environmental Policy Act (NEPA) compliance • Air quality compliance • Geotechnical engineering • Water/Waste water management • Geographic information systems (GIS) specialists
  • 5. Kelly Services global infrastructure AmErICAS EmEA ApAC Europe, Middle East, Asia-Pacific Temporary and Africa Temporary to Hire Direct Hire On-site Management Payroll Services Areas of Expertise Automotive Contact Center Creative Services Education Electronic Assembly Engineering Finance and Accounting Government Healthcare Industrial Information Technology Law Marketing Office Science project Services Project Teams Project Management PMO Integration SOW-based Services Outsourcing & Consulting Solutions Recruitment Process Outsourcing Business Process Outsourcing Contingent Workforce For more information, contact Kelly Services today. Outsourcing Daniel rhodes Human Resources phone :: 760.458.4505 Consulting E-mail :: daniel.rhodes@kellyservices.com Career Transition & Organizational Effectiveness michael ruchman Executive Search phone :: 858.232.7110 E-mail :: michael.ruchman@kellyservices.com kellyservices.com All trademarks are property of their respective owners. An Equal Opportunity Employer © 2010 Kelly Services, Inc. V0202 R5/10