Celerion

Celerion provides early-phase clinical research, laboratory and consulting services for drug development. Its services connect study design and trial execution with bioanalysis, biometrics, pharmacometrics and regulatory support.

Clinical Development and Trial Operations

• Plan and run early-phase clinical studies, including multi-site studies, through protocol development, first-in-human support, study start-up, site activation, participant recruitment and retention, project management, and full-service CRO execution.
• Monitor study conduct and medical oversight through on-site, remote, central, and risk-based monitoring, with documented training, issue escalation, deviation follow-up, source data verification, and medical review.

Clinical Data, Biometrics, and Pharmacology

• Manage clinical data from collection through cleaning and submission preparation, including EDC and CRF design and build, data review, reconciliation, SDTM and ADaM programming, statistical analysis plans, biostatistics, and tables, listings, and figures.
• Support pharmacology decisions with bioavailability and bioequivalence studies, clinical PK/PD analysis, population PK modeling, exposure-response modeling, and clinical pharmacology strategy for early-phase studies.

Bioanalysis and Laboratory Services

• Generate bioanalytical data for preclinical and clinical development through pharmacokinetic, immunogenicity, biomarker, cell-based, and drug metabolism assays for small- and large-molecule therapeutics.
• Conduct clinical sample analysis and laboratory logistics in GLP-, GCLP- and CLIA-compliant laboratories, including bioanalysis, sample processing, and analysis; radiolabeled ADME services include metabolite identification and mass-balance assessments.

Regulatory and Submission Support

• Prepare and support regulatory submissions and interactions, including pre-IND work, IND authorship, compilation and submission, CTA and NDA submissions, agency meeting materials, regulatory strategy, dossier content, annual reports, and prescribing information. Celerion also acts as US agent, with FDA liaison services such as meeting requests and briefing package preparation.
• Deliver regulatory and clinical reporting materials, including integrated clinical study reports, scientific reports, and DSUR safety reporting.

Best Fit

• Best suited to sponsors seeking a CRO and laboratory services provider for early-phase clinical development, including multi-site studies, with connected clinical operations, biometrics, bioanalysis, pharmacometrics, and regulatory support.
• Also fits programs that need trial master file (eTMF) management as part of the CRO's service delivery.