Global Clinical Development

Strategic Early-Phase & PK Clinical Trial Execution

Celerion’s Global Clinical Development (GCD) team provides full-service CRO support for early-phase multi-site clinical studies conducted external to our clinical pharmacology units (CPUs). Specialized in complex renal and hepatic impairment pharmacokinetic (PK) studies, our strategic approach seamlessly integrates patient arms into a single Phase I protocol. This enables a rapid, streamlined transition from first-in-patient trials through clinical Proof-of-Concept (PoC) and Phase IIa studies. By leveraging our global site network, dedicated clinical monitoring, and rigorous compliance standards, we accelerate data delivery while ensuring total data integrity.

Integrated Patient-Arm Strategies for First-In-Patient Protocols

Renal and Hepatic Insufficiency Study Expertise

Celerion adds significant value to your program through the combination of our operational skills, specialist procedures, and access to clinical expertise and patient populations.

Our vast networks of external sites have access to patients for key therapeutic areas including; hepatic or renal insufficiency, oncology (over 25 indications within this complex therapeutic area), vaccines, immunotherapy, infectious disease (viral or bacterial), respiratory disease (asthma, COPD, cystic fibrosis), and other therapeutic experience including metabolism (MASH, obesity, T2DM).

Celerion’s highly experienced project managers are skilled at leading, monitoring and analyzing all aspects of your trial – operations, timeline, budget and quality. They will provide expert advice and leadership of multidisciplinary drug development teams, integrating nonclinical, clinical, medical, and regulatory disciplines. We work with you from study start-up through submission of the integrated clinical study report.

Row H - 50_50 + Full Width Text Section - Long for _Leverage our Experienced Site Network

Streamlined Project Management & Site Network Support

In this video, Abbey Townsend, Senior Director of Global Clinical Development, explains key challenges and strategies for managing PK studies efficiently and cost-effectively, highlighting our partnerships with top investigators.

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Dedicated Global Project Managers Ensuring Compliance & Data Integrity

  • We minimize your risk through early problem identification, implementation of mitigation strategies, and through close monitoring of project plans and key project and decision drivers.
  • Your study is executed by highly-trained and organized teams that are closely coordinated through streamlined communication and have rapid access to senior management via a flat organizational structure.
  • Monitoring plans are tailored to each specific study and compliance-oriented methodology taking into account each study site, deploying risk-based monitoring, or a custom solution.

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Tailored Clinical Monitoring Services

Celerion deploys a regionally-based monitoring staff to minimize travel and maximize time on site. Our clinical research associates (CRAs) are commonly from a life-science background with over 10 years’ experience in the field as a CRA. With a focus on quality and data integrity, Celerion CRAs complete a rigorous training curriculum, assuring compliance with ICH GCP, as well as all state and local regulations. Our highly-qualified and experienced monitors will ensure compliance, training, and support of the clinical site(s).

Source Data Verification (SDV) by Specialized Clinical Monitors

  • Our processes and systems allow for higher quality, optimization, and faster data delivery.
  • At external clinics, such as renal and hepatic impairment sites, we focus on specific requirements related to these patient studies.

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CLINICAL MONITORING PlAN

Celerion develops a flexible clinical monitoring plan that includes the proposed frequency and duration of the Routine Monitoring Visits (RMVs) and your data entry expectations, but allows for adjustments in visit frequency dependent on the needs of the study.

Compliance Verification_

COMPLIANCE VERIFICATION

We systematically evaluate the compliance of the conduct of the study to the protocol, perform SDV, ensure the safety and welfare of the subject has been protected, and that the conduct of the study has complied with applicable GCPs and local/national regulations and guidelines.

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UNPARALLELED TRAINING

Our experienced monitors are held to a consistent, high level of training including GCP, electronic data capture (EDC), and Celerion’s very stringent SOP curriculum.

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REAL-TIME TRACKING

Our clinical monitoring team is experienced in many different EDC platforms and utilizes our CTMS to facilitate greater tracking and accountability.

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AN EXTENSION OF YOUR STUDY TEAM

Our monitors seek to establish true partnerships between study sponsors, research sites and the project team.

CLINICAL SPOTLIGHT

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