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Medpace CRO Regulatory Submissions
Regulatory Submissions


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GENERAL CAPABILITIES




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Medpace Regulatory Submissions teams deliver a well-coordinated, collaborative approach that is critical to every phase of global trials. Our unique team structure ensures each Sponsor benefits from global expertise in every aspect – from writing informed consents, to translations, to working with regulatory authorities and ethics committees.

Working directly with your local Clinical Research Associate, as well as Regulatory, Safety and Contract Groups, a fully dedicated specialist oversees all aspects of your investigator document collection and submissions, including:

  • Regulatory Agency and IRB/EC submissions.
  • Procurement of Import/Export license, as applicable.
  • Compilation of initial submissions, amendments, notifications, and closeout submissions.
  • Collection, review, and approval of site essential documents.

Medpace has extensive experience submitting clinical trials in over 30 countries and has strategic regional presence throughout Europe, Asia, Australia, South Africa, and the Americas.

Every country and site are different, and Medpace global submissions teams have extensive experience in the execution of multiple Clinical Trial Agreements (site, investigator, laboratory, etc.). Always concerned with protecting your liability, your submissions team collaborates and consults with dedicated Medpace in-house attorneys to finalize all contracts and agreements, saving Sponsors up to a week in turnaround time.

Proactive, strategic, and experienced

Working within our global standard operating procedures (SOPs), our dedicated specialists coordinate and oversee the study activities at project start-up and throughout the study. We rigorously maintain timelines for study start-up, ensuring your trial is delivered on time and on budget. And, we track metrics on all studies to better estimate new study submissions timelines.

Medpace creates a customized approach designed specifically to meet your submission process, including:

  • Country-specific submissions guidelines
  • Local contact information
  • Translation procedures
  • Informed Consent Form (ICF) negotiation guidelines

Our proactive and experienced employees are always ready to provide advice and guidance to Sponsors and investigative sites to ensure compliance with appropriate regulations and requirements. And because our teams work with documents every day, they are quick to recognize and flag any issues.

A breadth of capabilities

The Regulatory Submissions group:

  • Collects, reviews, organizes, and assembles regulatory start-up submissions.
  • Consults with the Medpace Medical Affairs group, including medical writers and regulatory experts, throughout your study.
  • Interacts with ethics committees and regulatory agencies.
  • Reviews pertinent regulations to develop proactive solutions to regulatory issues and challenges.
  • Negotiates and then prepares Informed Consent Forms (ICF) for the study sites to ensure the site meets local requirements. Works with the sites for changes requested on the ICF.
  • Obtains local insurance policies when necessary.
  • Represents the sponsor as a legal entity where required in different regions.
  • Works with the Sponsor to ensure all drug labels are correct.
  • Coordinates all document translations on a local level to ensure the most accurate and cost-effective documents.
  • Prepares, reviews, and files clinical trial applications to domestic and international regulatory agencies.
  • Ensures submissions comply with applicable regulations and guidance documents for each region.
  • Tracks submissions and ensures timely filing of documents.