Regulatory Study Startup and Activation

Enabling Efficient Study Startup & Maximizing Your Enrollment Period

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.

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.

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

More About Our Services

Have questions?

What are the study startup documents Minvera’s study startup team requires for regulatory compliance?

The study startup documents we require from the CRA or the sponsor include Form 1572, Financial Disclosure Forms (from PI & Sub-I), the latest version of the study protocol, protocol signature page/amendment PSP, the latest version of the investigational brochure, IP acknowledgment signature page, ECRF guidelines, EDC template, delegation log (DOA), electronic regulatory binder, if available, source data locator, EMR checklist and site contact forms (for PI, Sub-I, CRC, data entry techs, & lab tech).

Why is the initial IRB submission important?

The initial IRB submission must be done as per the requirement of the IRB and swiftly as this ensures the study site gains quick access to the IRB portal so that we could add all other regulatory coordinators to the IRB portal.

How do you effectively prepare the regulatory documentation?

Our backup regulatory team along with the study startup team work diligently to prepare the regulatory documents according to the instructions provided by the specific sponsor or CRA, while at some time consulting with the corporate regulatory team.

Regulatory Services: Expertise & Solutions that lead to Compliance & Monitor-readiness.

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Regulatory Study Startup & Activation