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| The selection of Phase I sites is critical to
the success of clinical development programs.
One of our goals is to provide our sponsors
access to quality Phase I sites with decreased
start-up time and accelerated patient accruals. |
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| In order to get Phase I studies initiated and
accruing as quickly as possible, we have
identified and audited several sites in the US
that 1) have the expertise to conduct Phase I
oncology trials and 2) utilize central IRBs. We
have executed Master Services Agreements (MSAs)
with these sites so the budget and contract
process is greatly simplified, saving valuable
start-up time. With these sites, our typical
start-up time from final protocol to site
initiation visit is 6-8 weeks. The Phase I
collaborative sites provide access to over
30,000 new oncology patients per year. Each site
is visited at least once per year, the
capabilities documented and patient population
profiled. |
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| Each site must meet certain minimum
qualifications including: |
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- Experience conducting studies in new molecular
development- Targeted, Biologic, Pharmaceutical
therapies
- Experience in Bioavailability/Bioequivalent
studies
- Pharmacokinetic sampling
- Outpatient facilities with extended hours to
accommodate trial needs
- State of the art equipment:
 Refrigerated centrifuge
-70˚
freezers
Back-up generators
PET/CT scanners
EKG monitoring
Interventional radiology (specific
sites)
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| It should be noted that although Veeda
Oncology has Phase I collaborative sites that
are available to sponsors, sponsors are
certainly not limited to using only those sites.
Veeda Oncology has access to other Phase I sites
which we are happy to contact at the Sponsor’s
request. |
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| Lastly, Veeda can provide laboratory services
for Phase I studies such as immunogenicity,
pharmacokinetics and biomarker services. For
more information on these services, please see
“Laboratory Services”. |
| |
| To know more about Veeda services or if you have any query please click
here to contact us |
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| To know more how veeda’s expertise and experience for Phase I trials
can help you, please be in touch with
us using this form |