We are a truly global CRO with centralized North American, South American, European, and Asian hubs with the staff and experience to help you activate sites in many countries, enroll qualified patients, ensure patient safety, and collect high quality clinical trial data. Our local country managers, medical directors, and monitoring teams can work independently or under the direction of a global project director.
Clinipace Worldwide is headquartered in Research Triangle Park, NC, USA with operations in the following regions, offering a full array of outsourced regulatory, strategic development, clinical development, and post-approval services:
Global clinical trials are best served by recognizing, valuing and respecting the diversity of every region involved. It pays to learn more about what study countries have to offer, and which of them best fits the needs of a specific study. As a global CRO, we have many experienced clinical research professionals around the world on our staff who can guide study sponsors in areas such as population demographics, regulatory timelines and regional capabilities. It pays to listen to these regional experts for the best possible outcome of a global clinical trial.
A global CRO navigating global regulatory challenges
In most countries, regulations exist to ensure the integrity of a clinical study and its outcomes; and, frequent, direct interaction with global regulatory agencies is required in order to navigate investigational new drug (IND) applications, new drug applications (NDA), and many other filings and approvals.
Whether submitting an original filing or an amendment, or converting an existing application to eCTD format, it's critical to work with a partner who understands local requirements and can publish and deliver an ICH-compliant submission.
Preserving patient safety
Preserving patient safety while maintaining the highest quality is a huge responsibility shared by all entities involved in a foreign trial, including regulatory authorities, ethical committees, pharmaceutical companies and sponsors, and CROs. Patient safety has always been the main shared concern among regulatory bodies continuously working to improve measures to accomplish this aim.
Worldwide, GCPs are the leading principles that guide every single step of clinical research to ensure patient respect and safety while standardizing essential procedures. However, it’s not just about reviewing these guidelines, but making them real in practice. It is our responsibility to ensure all parties follow GCPs through training, commitment, and supervision.