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Study Start Up

Laying the Foundation for Success

Study startup is a critical phase in the clinical trial process, encompassing all the preparatory activities required to ensure a trial’s smooth launch. This phase involves a series of complex tasks that must be executed with precision and efficiency to avoid delays and ensure regulatory compliance. At Insignia, we understand that a well-executed startup is key to the overall success of a clinical trial, which is why we place a strong emphasis on getting this phase right.

site selection & feasibility

Identifying the right sites is crucial for a successful trial. Insignia’s site selection process is data-driven and thorough, focusing on sites with a proven track record of performance in relevant therapeutic areas. We conduct comprehensive feasibility assessments to ensure that selected sites have the necessary resources, patient populations, and expertise to meet study requirements.

Regulatory Submissions and Approvals

Navigating the regulatory environment is one of the most challenging aspects of study startup. Insignia’s regulatory affairs team is adept at preparing and submitting all necessary documentation to regulatory authorities and ethics committees, ensuring timely approvals that keep your trial on schedule.

Contract and Budget Negotiations

Efficient contract and budget negotiations are essential to prevent delays during study startup. Insignia’s experienced team handles these negotiations with precision, ensuring that agreements are reached quickly and that budgets are aligned with study goals.

Investigator and Site Training

Proper training is vital for ensuring that all site personnel are equipped to conduct the trial according to protocol and regulatory requirements. Insignia provides comprehensive training programs for investigators and site staff, covering study procedures, GCP guidelines, and data management practices.

Patient Recruitment Planning

A robust patient recruitment strategy is essential for the timely enrollment of participants. Insignia works closely with sites to develop and implement tailored recruitment plans that leverage local knowledge and resources, helping to ensure that patient recruitment targets are met.

Site Initiation Visits (SIVs)

Site initiation visits are conducted to ensure that all study sites are fully prepared to begin the trial. During SIVs, Insignia’s clinical research associates (CRAs) review study protocols, confirm site readiness, and address any questions or concerns that site personnel may have.

Document Management

Managing the myriad documents required for study startup is a complex task that requires meticulous attention to detail. Insignia’s document management system ensures that all essential documents are prepared, reviewed, and stored according to regulatory requirements, facilitating smooth audits and inspections.

Insignia Excels in Study Startup?

Insignia’s excellence in study startup is driven by our commitment to efficiency, accuracy, and collaboration. Here’s why we stand out in this critical phase:

Collaborate with Insignia for a Successful Study Startup

When you choose Insignia, you’re partnering with a CRO that understands the importance of a flawless study startup. Our expertise, efficiency, and commitment to excellence ensure that your trial gets off to the best possible start, setting the stage for success throughout the entire clinical research process.