Trial Management

I. Project Management

At CMX-CRX, we are committed to the success of each clinical trial. Project Management is essential to successful and efficient clinical trial initiation, conduct, monitoring, completion and producing of valuable data. We demonstrate this through the delivery of expert services by our staff of professionals. A team of Project Manager, Study Monitor and Project Coordinator assigned for each individual clinical trial performs the following duties:

It is our strong belief that the Project Manager is the client’s point of contact, and is the leader of a team of clinical research professionals brought together to successfully complete the clinical trial. It is our goal to ensure that the highest quality services are provided to meet the sponsors and the sites needs to successfully complete your clinical trial.

		Based on investigator-initiated ideas
		Study design
		Sample size calculation and statistical analysis description
		Protocol preparation
		Informed Consent form preparation

		Original CTA filing with Health Canada
		CTA amendment filing
		AE, SAE reporting to Health Canada
		Ethics submission

		Network of 45 experienced research sites across Canada
		Various therapeutic areas (urology, family practice, dermatology, etc.)
		Network of sites allows for quick study launch
		Investigator’s meetings

		Site initiation
		Full or partial monitoring, as required for study
		Remote monitoring and on-site monitoring
		Adverse Event tracking
		Query resolution
		Study Supply Maintenance

		Interim reporting of results, where required
		Poster presentation for scientific meetings
		Final report writing by qualified physician

CMX understands the importance of clean data for analysis for a clinical research study. We work to provide Clinical Monitoring and Data Management planning prior to study initiation, along with ongoing accurate reports in order to deliver quality study results and reports using the traditional and using state-of-the-art technology platforms.

Our data management services at a glance:

		Case Report Forms creation, preparation and delivery
		Database design and management
		Data quality validation
		Query management
		Statistical analysis
		Study close-out/database lock
		Quality control and assurance (queries and data)
		Status reports (any format, including web-enabled secure access)
		Pre-planned and “ad hoc” summary reports
		Electronic data transfers

CMX takes full advantage of the efficiencies offered by Electronic Data Capture (EDC). We recognize the important impact that this technology has on the biopharmaceutical industry, including highly efficient data collection and processing.

The use of EDC enables a physician or physician’s assistant to enter patient data directly into an electronic Case Report Form (e-CRF), its content being maintained in an electronic database, for availability to the sponsor once it has been reviewed for accuracy and completeness by the clinical monitors and project managers.

CMX supports ongoing staff education and training.

Please contact Via: trialmanagement@cmxres.com