A well-defined and efficient study startup and activation strategy reduces overall study timelines and helps maximize the study’s overall enrollment period. To facilitate this, the Minerva Research Solutions regulatory study startup team works closely with the regulatory authorities, helping you manage all the regulatory requirements.
Enabling Efficient Study Startup & Maximizing Your Enrollment Period
We recognize the importance of efficiency in clinical trial processes and regulatory operations, which is why our study startup team works closely with the Ethics Committee/Institutional Review Board submissions team. Led by a dedicated operations department, our goal is to deliver agile and synchronous clinical trial management and regulatory operations solutions, that help your study achieve even more aggressive timelines.
— Competitive Advantage For Your Clinical Trial Success
Tailor-made Study Startup Process for your Protocol
Our study startup processes are tailored according to your protocol, and study milestones. Our study startup team seamlessly integrates with the study’s management team to ensure optimal operational and financial delivery of your study regulatory activities and reduce risks. We work closely with the sponsor or CRA to ensure all the study startup documents are prepared and organized as per their requirements, these include Form 1572 and, financial disclosure forms.
Our data-driven and innovative approach allows us to identify changes in the ever-changing regulatory environment and stay up-to-date with your studies. Streamline your regulatory compliance processes with the help of our regulatory startup team. Our goal is to ready customers to meet the challenges of study startup, more data, and cost pressures with our integrated approach to all things regulatory.
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What We Do?
Agile & Robust Regulatory Startup — Shortening Study Lifescycle
With study startups being one of the most crucial and initial areas of any clinical trial, our regulatory study startup team must develop effective processes and clear communication between the stakeholders including vendors, sponsors, ethics boards, and startup sites. Through stringent processes and timelines, our startup team does the following:
01
Regulatory-ready Documentations
02
Site Activation & Study Lifecycle Maintenance
03
Facilitating relevant Ethics & Review Boards Approvals
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Have questions?
Regulatory Services: Expertise & Solutions that lead to Compliance & Monitor-readiness.
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