Trialwise offers a range of clinical trial services including medical writing, project management, and study monitoring. Our clients range from startups to established biopharma companies.

The company provides a range of services to clients, including:

Clinical Operations Services

■    Vendor Management

■    Study Quality Risk Identification and Management

■    Site Selection

■    Site Essential Document Collection & Review

■    Central IRB/EC Submissions

■    Trial Master File Setup and Maintenance

■    Study Site Monitoring

■    Risk-Based Monitoring Strategy

■    Study Monitoring Plans

■    Study Binders and Reference Manuals

■    ICF Template Development

■    Source Document Template Development

 

CRO Oversight Services

■    Trip Report Review

■    TMF Audits

■    Co-Monitoring Visits

■    Monitoring Evaluation Visits

 

Medical Writing Services

■    Protocols and Protocol Amendments

■    Full and Synoptic Integrated Clinical Study Reports (CSRs) including but not limited to

→    Bioavailability and Bioequivalence

→    Drug-drug interaction

→    First in human -- SAD and MAD

→    Food effect

→    Hepatic and renal impairment

→    Immunogenicity

→    Pharmacokinetics and Pharmacodynamics

→    Thorough QTc (TQT)

■    CSR Addendum Documents

■    Safety Narratives and Safety Summaries

■    Investigator Brochures

■    Informed Consent Forms

■    Topline and Data Review & Interpretation PowerPoint slide decks

■    Educational Articles and Patient Brochures

■    Journal Manuscripts

 

Quality Assurance Services

■    Study Site Audits

■    Vendor Audits

■    SOP Development

■    Training