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| VEEDA ONCOLOGY CAN PROVIDE GLOBAL PATIENT
ACCESS WHILE MINIMIZING STUDY COSTS |
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| Problem: |
| The Sponsor of a global
supportive care study for patients with
non-small cell lung cancer was frustrated at the
lack of progress in India. The CRO that had been
entrusted with the study had been unable to
identify appropriate investigative sites and the
required regulatory documents had not been
submitted to the Indian Health Authorities. |
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| Solution: |
Initially, Veeda Oncology® was approached to
assist in site identification/feasibility of 11
sites in India. Within 3 weeks, we had queried
39 sites of which 29 had completed feasibility
questionnaires (86% response rate!). Due to our
successful site identification, the Sponsor
expanded our services to include the regulatory
submission, site management, project management
and monitoring services for the 11 sites with a
target accrual of 38 patients.
Below is a
summary of our performance to date: |
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- Regulatory Submission -
Submitted in October, 2008 with approval by
the DCGI the end of December, 2008.
- Site Initiations – Nine
sites were able to have Site Initiations in
January, 2009 with the remaining four visits
completed in early February. (Sponsor requested
an additional two sites.)
- Site Enrollment - As of
early February, 2009, the study has been open in
India for one month. Accruals have far exceeded
expectations with enrollment surpassing other
countries such as Russia, Georgia and Australia.
- Enrollment Cap Raised – Due
to our success in entering eligible patients
during the first month, the Sponsor increased
the maximum enrollment in India by approximately
50%. Since accruals in the other countries have
been disappointing, the consensus was that
opening more slots in India was the way to meet
their corporate objectives within the required
timeframe.
- Cost Savings – Cost Savings
– By shifting accruals from Australia and other
countries to India, there were significantly
lower per patient costs, leading to substantial
savings for the Sponsor.
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| To know more about Veeda services or if you have any query please click
here to contact us |
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