Sponsors
The Opulink Advantages - Oncology Trials
Opulink Corporation is a Trial Management Organization (TMO) which provides selected services of both SMO and CRO models into one large network of clinical sites capable of coordinating trials from Phase I – IV for Oncology clinical trials. We are focused on bringing new clinical trials to our physicians to provide new therapies for their patients.
To meet this goal, Opulink has partnered with the Geriatric Oncology Consortium (GOC) www.thegoc.org, with a membership of over 1,100 Oncology sites. The GOC sites treat oncology patients in all major areas and of all ages.
In addition, the GOC members are afforded additional information and education outreach programs specifically aimed at geriatric oncology issues and treatments. Opulink will maintain certification standards for investigator sites that wish to participate in clinical trials opportunities through Opulink. In addition, Opulink will conduct an ongoing quality assurance program to facilitate GCP and other certifications of their site personnel. The GOC resides in office space within Opulink’s company headquarters. The GOC has been managing specialty geriatric oncology clinical studies since 2002.
Using these advantages, Opulink not only can facilitate a measurable and faster cycle time for getting a site “up and running” on an oncology clinical trial but in addition, offer other clinical trial site management services because we have a working close relationship with our GOC sites.
- Protocol Review and Critique Forms
- Feasibility Assessment
- Screen Sites/ Site Initiation
- Site Evaluation Visit
- Site Evaluation phone Call
- Collect Start-up Regulatory Documents
- Support IRB submissions
- Contract Administration
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- Administer approval of amendments
- Remote Site Support
- Site Monitoring Visits
- Support IRB renewal
- Site Payment Report
- Site Close-out visit
- Manage IRB Fees
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Example of metrics involving a recent pharmaceutical contract:
Opulink was contracted by a pharmaceutical to recruit and place 20 sites on each of two studies. Within 3 weeks of the beginning of the assignment, Opulink completed the assessment of 100 sites, and identified over 40 qualified sites. After further screening, the sites were presented to the sponsor over the following 3 weeks.
Trials experience by percentage of the Opulink / GOC investigator sites
Percentage of trials experience of the Opulink / GOC Sites by treatment
OPULINK / GOC PRACTICE SETTINGS
Median # oncologists per site: 3 (range 1-13)
Median # coordinators per site: 1 (range 0-5)
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