Trialwise is a boutique contract research organization that
focuses on Phase I and II clinical studies

 

QUALITY

At Trialwise, we believe there's more to data reliability than source data verification, and that study monitoring shouldn't be graded by the number of tasks completed. Our study monitors focus on process, logical consistency, and prompt corrective and preventative action. Our clients have peace of mind that their study data are the best possible, and can be relied upon for future development strategy.

 

 

INNOVATION

Trialwise is excited about the future of drug development. We continually seek ways to improve processes, from organizational and communication workflows to technology. We are committed to successful implementation of eTMF and eSource solutions. Any technology can be implemented with good intentions and poor results; our experience uniquely qualifies us to implement successful technology solutions. 

EXPERIENCE

Trialwise personnel meet strict criteria including education, experience, and an attitude consistent with our company's culture and values. Trialwise team members are actively involved in professional societies and have a sincere interest in advancing their professions at the industry level.

  

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