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| Home > About Us > Veeda at Glance |
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Veeda Biometrics; a division of Veeda Clinical
Research with offices in Belgium, France, India, and
the U.S.; has over 20 years of experience in all
phases and designs of clinical research, spanning
across various therapeutic areas. Veeda Biometrics
is specialized in providing high quality data
management, statistics, and report writing services
in accordance with regulatory standards.
Veeda Biometrics is in an unparalleled position
to meet both the regional and global needs of
clients and deliver a unique service offering
combining the quality and experience of the West
with the intellectual ability and tireless work
ethic of the East at Eastern prices.
All services and systems are tailored to fit the
various clinical trial needs of clients, from
individual stand-alone services to outsourcing of
large studies, and are governed by well defined SOPs
which are compliant with regulatory requirements
such as ICH/GCP and FDA 21 CFR Part 11.
Through the close collaboration with other Veeda
Clinical Research departments, Veeda Biometrics has
gained extensive experience in early phase clinical
development, including oncology, and can make use of the
knowledge and experience of Veeda CR’s pharmacology
experts. Involvement in Phase I and II studies, from
initial planning to report writing, provided a sound
insight in pharmacokinetic and pharmacodynamic processes
in various domains. |
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| The services offered by Veeda Biometrics group include |
- Clinical Data Management
- Statistical Analysis and Programming
- Medical Writing
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| Veeda has been involved in the analysis of data from
all stages of clinical development with a variety of
designs and statistical hypotheses including interim
analyses using adaptive, sequential, and sample size
adjustment designs. The Veeda Biometrics staff has also
been involved in Independent Data Monitoring Committees
to assist in the decision-making process or to offer
statistical support independent from the sponsor. |
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| Statistical Analysis and Programming
Services include |
- Sample Size Calculation
- Study Design
- Randomization
- Statistical Analysis Plan
- TFL Programming
- Statistical Analysis
- Statistical Report
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| Clinical study reports are produced by the medical
writer, in collaboration with the medical team and the
project statistician, ensuring a complete and accurate
representation of all aspects of the study and its
results, while respecting tight timelines. The
integrated clinical reports are prepared according to
ICH E3 guidelines and format, or according to the
sponsor’s specific format. The final documents can be
published compliant to the requirements for an eCTD
submission. Support is provided for preparing abstracts,
posters and manuscripts |
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| Medical Writing Services include |
- Protocol
- Clinical Study Report
- PSUR
- ISE/ISS
- Abstract
- Poster
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| Systems used at Veeda Biometrics |
Clintrial: For Data Entry and Data
Management EDC: Experience with a range of different
eCRF systems.
Veeda partners with various EDC vendors to provide
Screen design, Flow design, determining the validation
checks, Testing etc.
SAS: For Statistical Analysis and Data
Management
Online Data Access: Access to the
clinical database is provided through a web portal
VeedaLink. The secure web portal contains a library of
standard reports as well as functionalities to provide
customized reports as per the study requirements.
WinNonlin: For Statistical Analysis of
PK/PD data. All systems at Veeda are CFR 21 part 11
compliant. |
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| Why Veeda Biometrics? |
Veeda Biometrics has unmatched expertise in
conducting global clinical trials for pharmaceutical,
biotechnology, and medical device companies. The sponsor
receives accurate data in the required global standard
format with high quality deliverables and cost savings
that only India can offer.
Apart from experience in robust Project Management which
integrates all the Biometrics services (Data Management,
Statistical Analysis and Medical Writing), Veeda adds
the value of its experience in providing Biometrics
support in various European languages.
Strong quality assurance permeates the culture, service
and operating philosophy of Veeda. While continuously
reviewing SOPs and working practices to identify areas
that can be developed to improve service, Veeda
Biometrics ensures synergy across its various units. |
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| In the past 5 years, Veeda Biometrics has |
- Completed more than 200 studies
- Worked with 8 of the Top 10 Bio-Pharmaceutical
companies
- Worked on all phases of drug development
- Experience in EDC / Paper studies
- Processed data from over 115,000 subjects
- Handled over 1 million CRF pages
- Participated in rescue studies
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| To know more about Veeda Oncology services or if you
have any query please
click here to contact us |
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Veeda Clinical Research Limited |