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TOI Clinical Research Services

Offering the full breadth of clinical trial services

Phases 1-3

Administrating all clinical trial phases

We conduct clinical trial phases 1, 2, and 3. We make sure to conduct these clinical trials by maintaining the highest levels of ethical behavior.

Follow-up

Patient follow-up

We care deeply for our patients and their health. After their participation in a clinical trial is over, we make sure to check up on them. Patient safety always is a priority.

Negotiations

Contract and budget negotiations

We are deeply involved in negotiating all contracts and budgets.

Data entry

Precise data entry

We have a qualified data entry team that precisely and consistently inputs patient data.

Protocols

Ensuring protocol compliance

Ensuring protocol compliance and conducting the study in the most efficient and effective way possible is always our goal. Adhering to the protocol and conducting ongoing training for amendments, if applicable, is what we do best.

Archival

Trial-related documents archival and maintenance

We archive and maintain all of our patients’ documents with the greatest care. We will never lose track of a patient’s document.

Initiation and close out

Site initiation and trial
close-out operations

We strive to accommodate site initiation visits within the sponsors’ needed timelines to ensure patient enrollment into each trial as quickly as possible. Our close-out visits are conducted effortlessly between the clinical team, regulatory team, and the investigators.

Approval

IRB/IFC Approval

Our regulatory team maintains great relationships with most Institutional Review Boards (IRBs) across the nation. This allows us to request expedited reviews in most situations.

Submission

Submission for Institutional Review Board (IRB) or Independent Ethics Committee (IEC)

Our regulatory team performs ongoing evaluation of the regulatory submissions as well as a 24-hour regulatory turnaround, if needed, to the IRB. These include initial applications, study status reports, continuing reviews, protocol amendments, and any other submission needed per International Conference on Harmonization (ICH) guidelines.

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