Clinical Trial Monitoring
Site Management Solutions
With the goal of ensuring site compliance, clinical trial monitoring is an essential element of clinical trials.
Clinical Trial Monitoring Consulting remains crucial for CROs and Sponsors to maintain solid oversight of clinical operations and evaluate the safety of subject, quality of data and compliance throughout the trial life cycle.
ZenTrial Consulting aims to excel at providing clinical site management services in Canadian provinces in French and English.
Site Management Services in a Nutshell
Monitoring Essentials
- Interim Monitoring
- Site Initiation leading up to Site Activation
- Qualification and Feasibility
- Site and Study close-out
Monitoring Activities
- Monitoring Report Authoring and Review
- Blinded / Unblinded Roles
- Essential Document Collection
- Remote Monitoring / eSource + eReg
- SDV/SDR
Therapeutics Areas
- Vaccines
- Cardiovascular
- Oncology
- Rare Diseases & Pediatric
- Gene Therapy & NA-based Therapeutics
- Orthopedics
- Other: let us know
Compliance
- Health Canada Regulations differ from the US and Europe. We can help!
- ICH GCP E6 (R3)
- ISO 14155 (Medical Devices)
- 21 CFR Part 11 / HIPAA / PIPEDA
Special Needs
- Urgent Monitoring Needs
- Audit Readiness & Site Support
- Interim Analysis & Database Freeze Support
- Site (Re-)Training
- Co-Monitoring
- Medical Writing / Monitoring Plan
- Site Startup & Activation Support
- Subject Enrolment Site Support
- French to/from English Translation
ZenTrial Geographical Area Coverage
Please note we are decentralized in Montreal, Quebec. We offer clinical monitoring in French and English.
We can help resourcing other geographies such as the US, Europe or the West Coast with our network of skilled professionals.
The list shows the different and most frequent geographical needs for monitoring that we can cover. We cover mostly Quebec, Ontario, the maritimes and Alberta.
- Quebec
- Quebec is a French-speaking province.
- – Montreal
- – Quebec
- – Sherbrooke
- – Trois-Rivières, Chicoutimi, other
- Ontario
- – Ottawa
- – Toronto
- – London
- Alberta
- – Calgary
- – Edmonton
- Maritimes
- East Coast of Canada
- – Nova Scotia
- – New Brunswick
- British Coliumbia
- – Vancouver
- USA East Coast and Great Lakes area
- It is possible to commute from Canada to the US by a CRA with competitiveness of consulting fees for full service area covrerage.
Experience and Professionalism
With over twenty years of experience in research, we will help you meet your study goals in the most efficient and seamless way possible. Continuous and ongoing site support allows us to achieve enhanced patient recruitment rates and deliver high-quality data. We understand the importance of your study data, subject safety, recruitment and retention while remaining GCP-compliant and audit ready.