Trialwise offers a range of clinical trial services including clinical operations, data management, biostatistics, clinical pharmacology, medical writing, and electronic publishing. Our clients range from startups to established biopharma companies.

Clinical Operations Services

■    Vendor Management

■    Study Quality Risk Identification and Management

■    Risk-based Monitoring Strategy (with biostatistics services)

■    Study Monitoring Plans

■    Site Selection

■    Site Essential Document Collection and Review

■    Central IRB Submissions

■    Trial Master File Setup and Maintenance

■    Study Binders and Reference Manuals

■    ICF and Source Document Development

■    Study Site Monitoring

Data Management Services

■    CRF Design and CRF Guidelines

■    Database Design, Build, and Validation

■    Edit Check Programming

■    Data Management Plans

■    Data Cleaning and Coding

Biostatistics Services

■    Complex Efficacy Endpoints

■    Statistical Analysis Plans (SAPs)

■    Statistical Programming and Analysis

■    Tables, Listings, and Figures (TLFs)

■    CDISC-compliant Datasets

Clinical Pharmacology Services

■    GLP-compliant Toxicokinetic (TK) Studies

■    Clinical Protocol Development Consulting

■    Pharmacokinetic (PK)/Pharmacodynamic (PD) Analysis Plans

■    PK/PD Data Analysis Using Validated Software (Phoenix® WinNonlin®)

■    Statistical Analysis of PK/PD Parameters

■    PK/PD TLFs

■    PK/PD Data Interpretation (integrated into CSR or standalone PK report)

■    Interim PK/PD Analyses

■    Dose Escalation Inter-cohort Analysis

Medical Writing Services

■    Investigator Brochures

■    IND Support

■    Trial Registration and Results Disclosure

■    Protocols and Protocol Amendments

■    Full and Synoptic Integrated Clinical Study Reports (CSRs) including:

→    ADME

→    First in Human (SAD and MAD)

→    Bioavailability and Bioequivalence

→    Drug-drug Interaction

→    Food Effect

→    Hepatic and Renal Impairment

→    PK/PD

→    Immunogenicity and Biomarkers

→    Thorough QTc (TQT)

■    CSR Addendum Documents

■    Safety Narratives and Safety Summaries

■    Electronic Publishing (Granular eCTD or Legacy NeeS)

Quality Assurance Services

■    Study Site Audits

■    Vendor Audits

■    SOP Development

■    Training