Put your REMS in inVentiv hands - inVentiv Health

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all we offer
A REMS touches
every part of your organization. ation. inVentiv Health can manage every
part of your REMS.
Strategy teg
development
Whether you have a compound in early clinical development or a fully commercialized brand,
making the right moves early in the REMS process can determine future success. So, even
before your compound receives a REMS mandate, inVentiv can guide you. We’ll analyze the
risk scenario and outline the likely scope of your requirements. From there, we can develop an
optimal FDA negotiation strategy. inVentiv knows that if you set your brand on the right course
early, it’s less likely to lose its way later on.
Program design
Rely on the expertise of inVentiv to design your REMS right, with properly scaled, well-targeted
tools to help ensure safe and appropriate use. If you need a comprehensive plan, our broad
capabilities can coordinate seamlessly across clinical, regulatory, and marketing. If the need
is more limited, we provide focused expertise that complements your larger program and
existing in-house resources. Communication plans, patient and prescriber registries, reimbursement
programs, performance-linked access systems, and distribution through specialty
pharmacies—whatever the need, inVentiv can design a solution.
Implementation
The way we see it, a well-implemented REMS program supports your larger brand goals. Minimal
burdens on stakeholders, clear communication, and streamlined access can serve both
to mitigate product risks and deepen brand connections. At inVentiv, we’ve mastered the arts
of risk education and communication, database development and management, and pharmacovigilance.
After executing programs for scores of brands with significant safety risks, we’re
comfortable working in highly regulated spaces, which means you’ll be comfortable, too.
Evaluation and reporting
While failure to meet REMS objectives can lead to severe consequences, effective
execution may result in early release from monitoring requirements. To this high-stakes
endeavor inVentiv brings a variety of resources to meet your needs, including analytics,
consulting services, logistics, and distribution. We can execute stakeholder surveys that
measure understanding of risks and processes. We can manage data on adverse events and
other outcome metrics for you. We can even design and prepare your reporting packages.
It’s all part of helping your REMS be a well-managed component of your brand’s success.