This document summarizes the project services offered by Kelly. It provides scalable project development and deployment, customized PMO integration solutions, global talent delivery, and targeted industry-specific expertise. Kelly leverages over 44 years of expertise in scientific research, information technology, engineering, clinical research and development, FDA liaison activities, and IT solutions to support critical-path studies and drive innovation for clients.
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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