Best Practices to Drive Time and Cost Savings for Contraceptives | Page 11

In order to effectively utilize RBM, central and timely monitoring is

contraception trials, the case report forms remain relatively simple

needed, ideally using a technology-driven solution. The FDA recognizes

to capture information about women who are generally otherwise

the importance of this, particularly when trials are conducted remotely

healthy and objective endpoints such as pregnancy or infection.

or at multiple sites.

Therefore, they are well suited to the use of RBM. Further, according
to the FDA, the characteristics of contraceptive trials are ideal for

RBM allows for dynamic monitoring and continual trial improvement.

centralized monitoring. The objective endpoints can be easily coded

Deviations from protocol can be proactively identified and addressed,

into central software, as opposed to subjective endpoints that are not

whether through training, protocol clarifications, or protocol

as easily defined. Large quantities of data are collected over a long

amendments, if needed. Sites that are considered high-risk because

period of time, resulting in thousands of data points for daily activity

of poor enrollment, inappropriate enrollment, poor compliance,

monitoring. Contraceptives are relatively safe, resulting in fewer risks

or poor monitoring can be identified, allowing for targeted site visits.

to participants. As a result, RBM has been successfully implemented in
previous contraception trials.

In order to effectively utilize RBM, central
and timely monitoring is needed, ideally
using a technology-driven solution.
The FDA recognizes the importance of this,

Technology-enabled enrollment,
compliance and monitoring »
Clinipace Worldwide has pioneered a proprietary e-clinical,
cloud-based software platform, TEMPO™, which can help to address
the challenges with appropriate trial enrollment, compliance, and

particularly when trials are conducted

monitoring. TEMPO allows for protocol and patient profile data in

remotely or at multiple sites.

addition to data from all sites to be stored and accessed in a central
database that is updated in real time, enabling transparency across
the entire trial lifecycle, increasing data quality, and facilitating

In this way, RBM can reduce trial costs, by employing only the

proactive, informed decisions about the research.

minimally effective number of people for trial management and
monitoring and incurring fewer travel costs for site visits.

Recruitment and enrollment tracking ensures a representative
sample that complies with regulatory requirements. Sites that

With the right RBM tools, RBM can be applied to the majority of

are performing poorly in terms of enrollment can be easily and

clinical trials. However, with greater complexity, such as that with

automatically identified, and remedies can be immediately

oncology trials, the implementation becomes more complex. With

employed to improve enrollment.

clinipace.com

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