Method Development
LC-MS/MS and LBA method development for small and large molecules.
Learn moreFull bioanalytical method development, validation, and sample analysis.
Method Validation
Full ICH M10-compliant method validation.
Learn moreSample Analysis
High-throughput sample analysis with rapid turnaround.
Learn moreBiomarker Analysis
Biomarker assay development and analysis.
Learn moreImmunogenicity
Anti-drug antibody (ADA) and neutralizing antibody assays.
Learn morePK Analysis
Pharmacokinetic analysis and modeling.
Learn moreEnd-to-end clinical development services from first-in-human through Phase IV.
Early Phase Studies
First-in-Human (FIH), single ascending dose (SAD), and multiple ascending dose (MAD) trials.
Learn moreBA/BE Studies
Bioavailability and bioequivalence studies for generic drug development.
Learn moreFIH Trials
Comprehensive first-in-human trial design and execution.
Learn morePhase II–IV
Late-phase clinical trials with adaptive designs.
Learn moreeCOA/ePRO
Electronic clinical outcome assessments and patient-reported outcomes.
Learn moreMedical Monitoring
24/7 medical monitoring and safety oversight.
Learn moreStructured project management ensuring on-time, on-budget delivery.
Study Start-up
Rapid study start-up with parallel feasibility and regulatory submissions.
Learn moreSite Management
Global site management with pre-vetted investigator networks.
Learn moreMonitoring
Risk-based monitoring combining central statistical monitoring with targeted on-site visits.
Learn moreData Management
EDC, database design, and medical coding.
Learn morePharmacovigilance
Safety database management and expedited reporting.
Learn moreMedical Writing
Protocols, CSRs, and regulatory documents.
Learn moreRegulatory strategy, submissions, and agency communications worldwide.
IND/CTA Filing
Investigational New Drug and Clinical Trial Application filings.
Learn moreeCTD Submissions
Electronic Common Technical Document submissions.
Learn moreAgency Liaison
Direct communication with FDA, EMA, and global authorities.
Learn moreRegulatory Strategy
Integrated regulatory strategy across development programs.
Learn moreLabeling
Product labeling development and negotiation.
Learn moreLifecycle Management
Post-approval regulatory lifecycle management.
Learn more