Accelerate Trial Initiation with Precision and Expertise

At iGlobal, we understand that the success of your clinical trial begins with an efficient and well-executed start-up. Our Study Start-Up Teams deliver a strategic, customized approach that accelerates trial activation while ensuring the highest standards of quality and compliance. From global regulatory submissions to site readiness, we provide seamless coordination across every milestone of the start-up process.

Swift Study Activation: Expertise Meets Execution

Collaborative and Strategic Approach

Our dedicated start-up specialists collaborate closely with therapeutic and regulatory experts to provide strategic guidance and proactive solutions tailored to your study’s unique requirements. Leveraging our global presence across North America, EMEA, Asia-Pacific, and Latin America, we bring together the best of local insights and global expertise to navigate complex regulatory landscapes, streamline site activations, and ensure rapid trial initiation.

Our Approach to Study Start-Up

Proactive Solutions:

iGlobal’s start-up specialists develop forward-thinking strategies to mitigate regulatory challenges, ensuring trials are initiated on time and within budget. Our teams coordinate and oversee:

  • Study submissions to Regulatory Authorities and Ethics Committees.
  • Essential document collection, preparation, and review.
  • Contract and budget negotiations with expedited timelines.

Tailored Customization

No two trials are alike. iGlobal crafts individualized plans tailored to your study’s specific challenges. From informed consent form (ICF) negotiations to multi-country submissions and translation procedures,
every detail is optimized to accelerate site readiness and ensure compliance.

Unmatched Experience

With start-up specialists who have initiated trials in over 75 countries, our team brings a wealth of expertise across clinical operations and global regulatory frameworks. This experience ensures that we anticipate obstacles, deliver innovative solutions, and maintain consistent momentum across diverse regions and study phases.

Our Process: From Qualification to Initiation

1. Pre-Study Activities:
Site selection, qualification visits, and pre-study documentation preparation to lay the groundwork for trial success.
2. Core Documentation Development:
Customized plans for informed consent forms (ICFs), essential document collection, and site-specific templates.
3. Regulatory Submissions & Approvals:
Comprehensive regulatory strategies for country-specific submissions, ethics approvals, and compliance.
4. Site Contracts & Budgets:
Negotiation and finalization of site contracts and budgets to streamline site activation.
5. Site Initiation Visits (SIVs):
Ensuring all sites are equipped, trained, and ready to begin subject enrollment.

Continuous Support Throughout Your Trial

Seamless Management of Amendments and Expansions
Our start-up specialists remain dedicated to your trial throughout its lifecycle, ensuring continuity and consistency when managing amendments, protocol changes, or the addition of new sites and countries. This ongoing support minimizes disruptions and keeps your study on track.

Centralized Oversight
Your dedicated Regulatory Affairs Manager (RAM) serves as your single point of contact for all study start-up activities. The RSM oversees the development and execution of your start-up strategy while coordinating with specialists to provide real-time updates on progress and timelines. This centralized approach ensures accountability, transparency, and rapid resolution of any challenges.

Why Choose iGlobal for Study Start-Up?

  • Global expertise combined with local insights to navigate regulatory complexities.
  • Proactive, customized solutions tailored to your study’s unique requirements.
  • Unparalleled experience in initiating trials across diverse therapeutic areas and regions.
  • Continuity and dedicated support throughout the trial lifecycle.

Accelerate your clinical trial with iGlobal’s precision-driven start-up solutions—where every step is designed to get your study off the ground, faster and smarter.