Trialwise is a boutique contract research organization specializing in study management, monitoring, and medical writing for 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 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