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TASC Research has developed a comprehensive set
of services that support our vaccine clinical trials site. We pride
ourselves in taking a consultative collaborative approach with our
sponsors. There are no shortcuts to quality, but there are proven
effective and efficient routes.
Our set of services include:
Pre-study feasibility analysis
Project management
Regulatory filings
Recruitment strategy development
Study management
At-home study visits
Post-study debriefing
We believe strongly that there is much to be gained
for both our sponsors and ourselves to be involved early in the
process.
TASC has developed a comprehensive set of pre-study
processes. Our most important first step is our protocol feasibility
analysis. Two senior staff examine the protocol separately. We establish
that a valid cohort of patients can be found from which to recruit
and that the study structure and activities are reasonable, given
calendar schedules. This field perspective analysis can provide
valuable insight towards fine tuning the protocol.
In study execution, we know that planning and tracking
are paramount. Our designated study teams define and document our
projects to the lowest identified steps. From the time of project
initiation we structure a plan and create supporting documents and
spreadsheets to track progress and build in quality. We provide
regular detailed updates to the sponsor and others as appropriate.
We work closely with the sponsor monitor to ensure
project objectives are met. The site remains in a poised position
to quickly respond to the unpredictable demands that can occur in
the course of a project.
TASC has an excellent record of accomplishment
in regulatory filings. Our turnaround is efficient with our local
ethics board being very familiar with vaccine studies.
When necessary, TASC also can take the lead role
on filing Clinical Trial Applications with Health Canada. These
applications are normally reviewed and approved within 30 days.
The key to a successful study is effective recruitment.
We pride ourselves at meeting or exceeding study specific recruitment
targets. If of value to the project, we will offer over-enrollment
as feasible. The site has the capability to recruit large (more
than 200) trials suitable to our population base when appropriate.
Staffed by experienced recruiters, along with access to a population
of 1.3 M, we continually build our networks through the support
realized from our dedication to serve the participant.
The conduct of studies at TASC Research is based
upon a rigorous plan and the delegation of duties to the staffing
level. We are functionally structured with a site manager, study
co-ordinators, study nurses, research assistants and quality assurance/data
management positions. For each study, project functions are completed
and tracked to plan. This 'real time' analysis identifies protocol,
data or procedural issues, directing immediate attention toward
any corrective measures that may be required. We also provide a
service to investigators by facilitating their participation in
quality driven ethical research studies in the community.
One of our unique core services is that we include
home visits in our studies whenever possible. We believe that for
paediatric or geriatric studies, it is a significant convenience
to go to the subject. While taking more time than seeing these patients
at our site, recruitment and retention are enhanced.
We believe that each study provides significant insights
both in the project's uniqueness and potential duplicity. Ideally
done collaboratively with our sponsors, we examine all aspects of
the study. This immediate retrospective review invariably proves
of value to both the sponsor and the site in future endeavours.
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