Monday May 19. 2025
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Uniqueness

The Care-Safe team provides our clients with a unique opportunity to access the broad and deep experience offered by our team of professionals. We can provide dedicated resources to help jump start initiatives, provide start-to-finish services for a defined project, or can serve as an ongoing resource to our clients to be accessed on an as-needed basis.


Clinical Safety Services

Our experience in clinical safety data analysis and interpretation is unparalled. The Care-Safe principals bring a wealth of knowledge and training, with the ability to provide both pharmaceutical and medical device industry-standard consultation. Our cumulative experience as physicians, medical monitors, data analysts, clinical researchers, regulatory and quality assurance professionals ensure that our services are thorough and considered. Further, through our affiliated partnerships, we can seamlessly provide additional services and expertise, including biostatistics, data management and epidemiology.


Central Data Monitoring Committee Services

Care-Safe's approaches to DMC services are truly unique.

Serving as a Central DMC is a core competency of our group, not an afterthought or "add-on" service as provided by many CROs.

Our highly experienced principals and partners will serve as members of your DMC, adding specific therapeutic expertise as needed. The core members of your Care-Safe DMC will be fully engaged in the process, with an in-depth understanding of the protocol and DMC Charter.

Care-Safe DMC meetings are almost exclusively held as face-to-face meetings. Because of our strategic location in the Boston area, we are generally able to engage expert clinicians and other needed members who are local. This allows for more thoughtful, productive discussion resulting in the best possible decision-making. Of course, as needed, we can facilitate inclusion of DMC members from any location via teleconference or video conference.



Contact us for more info


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Guidance: Data
Monitoring Committees
Read the federal guidance document concerning the establishment and operation of clinical trial data monitoring committees.
Read the guidance...






Guidance:
Pharmacovigilance &
Pharmacoepidemiology
Read the federal guidance document concerning good pharmacovigilance practices and pharmacoepidemiology assessments.
Read the guidance...


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Clinical Operations, Strategic Planning and Analyses
Data Monitoring Committees