Oz@UHN

Your Trusted Partner in Clinical Trials

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Welcome to Oz@UHN

Oz@UHN is an Innovation Core that provides service for UHN Investigators to provide Sponsor level support for Investigator Initiated Trials (IITs).

Oz@UHN offers highly trained staff, with expertise running national and international clinical trials. We have extensive Standard Operating Procedures (SOP), Quality Management System (QMS), and Canadian and International regulatory experience.

Oz@UHN Provides UHN investigators access to expertise to design and implement Phase I, II, and III clinical trials and enable high-quality research.

Our services can be tapped into by UHN investigators quickly and efficiently as a master services agreement is in place. Statements of work for individual trials can be fully executed within days.

Our Services

Oz@UHN services can be customized to the specific requirements of each UHN Investigator. Our areas of expertise and services include:

Concept Development

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Icon image of light bulb

Concept Development

  • blue checkmark iconDevelop clinically relevant research projects designed to match the investigator's objective.
  • blue checkmark iconBringing study concepts to development.
  • blue checkmark iconRecommend innovative strategies for drug development studies by offering scientific, medical, and regulatory advice on how best to develop an investigational agent.

Project & Site Management
+

Icon image of MRI

Project & Site Management

  • blue checkmark iconProject management in research is critical and ensures trials are completed on time and within budget.
  • blue checkmark iconClinical trials specialists ensure regulatory compliance at all times and oversee and manage clinical studies, from study start-ups to database locks.

Site Selection & Study Start-Up
+

Icon image of atom

Site Selection & Study Start-Up

  • blue checkmark iconPrompt identification of qualified sites.
  • blue checkmark iconSite selection process includes feasibility assessments, pre-study visits, and verification of ongoing requirements.

Regulatory Services

+

Icon image of one eye

Regulatory Services

  • blue checkmark iconMonitoring and reporting of the quality, safety, and efficacy of Phase I, II, and III clinical trials to ensure compliance with regulatory requirements on safety reporting.
  • blue checkmark iconExtensive knowledge regarding North American regulations and will ensure the study maintains compliance with these regulations, as applicable.

The following are a selection of regulatory services we can provide:

  • blue checkmark iconClinical Trial Applications
  • blue checkmark iconRegulatory reporting of Serious Adverse Event (SAE)
  • blue checkmark iconContinuous correspondence with regulatory authorities
  • blue checkmark iconRegulatory tracking, collection, review, and filing
  • blue checkmark iconMaintenance of the trial master file (TMF)
  • blue checkmark iconAudit Preparation

Medical Services

+

Icon image of heart

Medical Services

  • blue checkmark iconMedical safety monitoring (review of safety data for regulatory reporting).
  • blue checkmark iconMedical Writing

Data Management

+

Icon image of Server

Data Management

  • blue checkmark iconOz@UHN is an accredited Medidata Rave EDC partner.
  • blue checkmark iconData management personnel work closely UHN PI's from study design to analysis, ensuring that the data collected is valid, accurate, and verifiable. We ensure data integrity at every study stage.
  • blue checkmark iconDevelopment of protocol-specific eCRFs (electronic case report form) and eCRF guidelines.
  • blue checkmark iconDevelopment of data management plan (DMP)

We provide the following:

  • blue checkmark iconeCRF design and development
  • blue checkmark iconData collection and processing
  • blue checkmark iconDatabase building
  • blue checkmark iconAccredited builders

On-Site/Remote Monitoring
+

Icon image of on-site

On-Site/Remote Monitoring

Oz@UHN performs clinical trial monitoring in accordance with ICH GCP guidelines to ensure that the rights and well-being of human subjects are protected. This also guarantees that the reported trial data are accurate, complete, and verifiable from source documents and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s) and applicable regulatory requirements.

Our monitoring services include:

  • blue checkmark iconPrestudy Visits
  • blue checkmark iconInitiation Visits
  • blue checkmark iconRegular Monitoring Visits
  • blue checkmark iconSite Close-Out
  • blue checkmark iconDrug Accountability
  • blue checkmark iconCorrelative Lab Visits
  • blue checkmark iconDevelop Monitoring plan

Quality Management System
+

Icon image of quality

Quality Management System

We work to ensure that our service to our investigators is consistent, reliable, and of the highest standard.

  • blue checkmark iconQuality Metrics
  • blue checkmark iconSOPs
  • blue checkmark iconProcess Reviews & Improvements
  • blue checkmark iconQuality Control
  • blue checkmark iconDocument Control
  • blue checkmark iconQuality Assurance (Audits)
  • blue checkmark iconTraining

Our Services

Oz@UHN services can be customized to the specific requirements of each UHN Investigator. Our areas of expertise and services include:

Concept Development

+

Icon image of light bulb

Concept Development

  • blue checkmark iconDevelop clinically relevant research projects designed to match the investigator's objective.
  • blue checkmark iconBringing study concepts to development.
  • blue checkmark iconRecommend innovative strategies for drug development studies by offering scientific, medical, and regulatory advice on how best to develop an investigational agent.

Project & Site Management
+

Icon image of MRI

Project & Site Management

  • blue checkmark iconProject management in research is critical and ensures trials are completed on time and within budget.
  • blue checkmark iconClinical trials specialists ensure regulatory compliance at all times and oversee and manage clinical studies, from study start-ups to database locks.

Site Selection & Study Start-Up
+

Icon image of atom

Site Selection & Study Start-Up

  • blue checkmark iconPrompt identification of qualified sites.
  • blue checkmark iconSite selection process includes feasibility assessments, pre-study visits, and verification of ongoing requirements.

Regulatory Services

+

Icon image of one eye

Regulatory Services

  • blue checkmark iconMonitoring and reporting of the quality, safety, and efficacy of Phase I, II, and III clinical trials to ensure compliance with regulatory requirements on safety reporting.
  • blue checkmark iconExtensive knowledge regarding North American regulations and will ensure the study maintains compliance with these regulations, as applicable.

The following are a selection of regulatory services we can provide:

  • blue checkmark iconClinical Trial Applications
  • blue checkmark iconRegulatory reporting of Serious Adverse Event (SAE)
  • blue checkmark iconContinuous correspondence with regulatory authorities
  • blue checkmark iconRegulatory tracking, collection, review, and filing
  • blue checkmark iconMaintenance of the trial master file (TMF)
  • blue checkmark iconAudit Preparation

Medical Services

+

Icon image of heart

Medical Services

  • blue checkmark iconMedical safety monitoring (review of safety data for regulatory reporting).
  • blue checkmark iconMedical Writing

Data Management

+

Icon image of Server

Data Management

  • blue checkmark iconOz@UHN is an accredited Medidata Rave EDC partner.
  • blue checkmark iconData management personnel work closely UHN PI's from study design to analysis, ensuring that the data collected is valid, accurate, and verifiable. We ensure data integrity at every study stage.
  • blue checkmark iconDevelopment of protocol-specific eCRFs (electronic case report form) and eCRF guidelines.
  • blue checkmark iconDevelopment of data management plan (DMP)

We provide the following:

  • blue checkmark iconeCRF design and development
  • blue checkmark iconData collection and processing
  • blue checkmark iconDatabase building
  • blue checkmark iconAccredited builders

On-Site/Remote Monitoring
+

Icon image of on-site

On-Site/Remote Monitoring

Oz@UHN performs clinical trial monitoring in accordance with ICH GCP guidelines to ensure that the rights and well-being of human subjects are protected. This also guarantees that the reported trial data are accurate, complete, and verifiable from source documents and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s) and applicable regulatory requirements.

Our monitoring services include:

  • blue checkmark iconPrestudy Visits
  • blue checkmark iconInitiation Visits
  • blue checkmark iconRegular Monitoring Visits
  • blue checkmark iconSite Close-Out
  • blue checkmark iconDrug Accountability
  • blue checkmark iconCorrelative Lab Visits
  • blue checkmark iconDevelop Monitoring plan

Quality Management System
+

Icon image of quality

Quality Management System

We work to ensure that our service to our investigators is consistent, reliable, and of the highest standard.

  • blue checkmark iconQuality Metrics
  • blue checkmark iconSOPs
  • blue checkmark iconProcess Reviews & Improvements
  • blue checkmark iconQuality Control
  • blue checkmark iconDocument Control
  • blue checkmark iconQuality Assurance (Audits)
  • blue checkmark iconTraining

Our Executive Team

Our executive team has extensive experience designing and managing clinical trials.
picture of >DR. Amit Oza

Dr. Amit Oza

Chief Executive Officer
Medical Oncologist,
Professor of Medicine,
Director of CCRU,
Co-Director of DDP
picture of Jacqueline Amaral

Jacqueline Amaral

Chief Operating Officer
picture of Jessie Miller

Jessie Miller

Senior Director - Operations
picture of Cindy Yau

Cindy Yau

Senior Director - Quality Assurance and Regulatory Affairs
picture of Darcy Vincett

Darcy Vincett

Director - Data Management

Contact Us

Oz@UHN

Oz@UHN is located at:
700 University Avenue,
Suite 217-2N
Toronto, Ontario
Canada, M5G 1Z5

Email: jackie.amaral@ozmosisresearch.ca
Phone: (+1) 416-634-8300
Fax: (+1) 416-634-8333