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| Regulatory support is crucial
to all phases of the drug development
process. Veeda Oncology is dedicated to
providing you with regulatory support that is
completely committed to the success of your
program. Our focus is to assure compliance with
all regulatory requirements. From a clinical
trial perspective, Veeda Oncology
provides the following services: |
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- Comprehensive clinical trial document
preparation/review
- Approval of investigator packets required
for release of investigational product
- Development and review of informed consent
forms
- Fulfillment of regulatory requirements for
specific countries and regions
- Assurance of Good Clinical Practice (GCP)
compliance
- Completion of audits and corrective action
plans
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| Additionally, Veeda Oncology can assist with
Investigational New Drug (IND) and New Drug
Application (NDA) filings to the US FDA as well
as regulatory filings in Europe and parts of
Asia. |
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| Veeda Oncology’s independent global Quality
Assurance department is staffed by a team of
experienced QA professionals in North America,
Europe and India. The QA department is entirely
separate from and independent of the personnel
engaged in the direction and conduct of clinical
trials. |
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| We perform audits in all stages of the
project: |
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- Protocol audit
- Trial master file (TMF) audit
- Investigator site audit
- Database audit
- Report audit
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| Internal systems audits include a
comprehensive review of procedures and processes
followed in the management of clinical trials
and are geared towards the identification of
weaknesses, as well as increased efficiencies. |
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| All audits are performed to assess adherence
and compliance with Standard Operating
Procedures (SOPs), Good Clinical Practice (GCP)
guidelines, regulatory requirements, the trial
protocol, client instructions, and contractual
obligations. |
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