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inVentiv Clinical Solutions, LLC
Stephen Cottrell, Sr. VP Business Development
15915 Katy Freeway, Suite 100
Houston, TX 77094 USA
Phone: 866-707-9567
E-mail:
Web: http://www.inventivclinical.com
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Who is inVentiv Clinical Solutions?
At inVentiv Clinical Solutions, our mission is to be the premier
provider of unique clinical outsourcing solutions to the
pharmaceutical, biotechnology and medical device industries,
allowing our clients the greatest flexibility through unmatched
access to high quality clinical resources.
As a strategic partner, inVentiv Clinical Solutions provides our
clients with a variety of flexible options to meet their clinical
trial objectives, including outsourcing of one or several functions
associated with the clinical trial process, expert clinical
staffing and recruitment, and creating strategically resourced work
groups. All our solutions are designed to increase efficiencies and
accelerate results.
Clinical Operations Solutions
From investigator selection and patient recruitment to
regulatory submission and GCP training, inVentiv Clinical provides
comprehensive and flexible clinical operations solutions. We can
help you navigate regulatory, clinical, and research projects to
achieve both short and long term objectives. Services include:
- Protocol/CRF Design
- Investigator & Patient Recruitment
- Clinical Trial Management
- Site Monitoring
- Regulatory Affairs Consulting/Liaison
- Comprehensive GCP Training
Data Management & Biostatistics
inVentiv Clinical provides customized integration of data
management, statistical, and medical writing expertise on every
project. We take a 360-degree approach to data management,
analysis, and reporting, which ensures your data is collected,
queried, cleaned and processed in an organized and consistent
manner.
We carefully evaluate the needs of your individual project or
program. Then we customize our databases to meet those needs.
Data Management Services
- CRF design, printing and annotation
- Database design
- Double key data entry and validation
- Medical coding
- Edit checks and data validation
- DCF (query) generation
- AE/SAE reconciliation and database development
- Data harmonization
- Electronic Data Capture (EDC)
- Off-Shore Solutions
Biostatistical Services
- Study design including sample size determination
- Statistical Analysis Plans
- Statistical analysis: efficacy, safety, exploratory, ISE, ISS,
BE, BA and PK/PD
- Integrated statistical reports
- DSMC Support
Medical Writing
- Clinical Trial Report (CTR) writing
- Integrated clinical and statistical reports
- Other clinical manuscript preparation
Strategic Resource Groups
inVentiv Clinical's Strategic Resource Group solution (SRG)
provides you access to longer-term relationships with critical
personnel while allowing you to maintain headcount flexibility
throughout evolving resource needs.
We work with you to identify the right mix of personnel to build
an SRG that meets your needs. Our industry-leading contract
staffing divisions quickly identify the appropriate personnel for
your SRG. Then we manage the employment details through our Human
Resources team so you can realize efficiencies throughout the
project scope and effectively manage co-employment risks.
Contract Staffing
Complimenting our clinical solutions offerings, inVentiv
Clinical can provide you with clinical and scientific contract
staffing through our industry-leading staffing divisions, MedFocus
and Smith Hanley Consulting.
We provide the expertise of more than 60 full-time recruiters
who utilize a proprietary candidate database that includes more
than 60,000 clinical, scientific, and information management
professionals spanning all aspects of clinical research. You can
trust our team to quickly and easily fulfill any staffing need,
from full clinical teams to individual clinical professionals at
any level.
Off-Shore Solutions (India)
With the increasingly rigorous requirements of today's
clinical development process, access to 24x7 data management and
biostatistics capabilities is essential to accelerating your study
timelines and getting your data to the FDA on time. inVentiv Pharma
Services in India brings short and long term value by providing
access to highly scalable resources in data management,
biostatistics and SAS programming in Mumbai and New Delhi,
India.
inVentiv Pharma Services’ highly experienced, English speaking
resources in India provide added time zone coverage, meaning
accelerated ramp up and strong, cost-effective execution of data
management and biostatistics services. You can be assured of an
established technology infrastructure and a team of more than 200
ICH/GCP, 21 CFR Part 11 trained professionals.
inVentiv Clinical Solutions, LLC
Stephen Cottrell, Sr. VP Business Development
15915 Katy Freeway, Suite 100
Houston, TX 77094 USA
Phone: 866-707-9567
E-mail:
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