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