Site Management

CMX Research Inc., a clinical trials company, offers one-stop shopping solutions for expedited study start up, site selection and budget negotiation with emphasis on ongoing QA to ensure optimum patient recruitment and retention. At CMX Research, we set our sights high. We know that our clients’ success depends on accurate and reliable data that complies with FDA, GCP and ICH Industry standards.

1. Site Management

		Site Selection
		Supervise sites in study conduction
		Assist in patient recruitment and retention endeavour
		Negotiate budgets and contracts
		Continuous Marketing Strategies
		Review Protocols & Feasibility Questionnaires
		Develop and Maintain QA Program
		Assist with training of staff
		New Business Development

		Scientific papers for publications
		Clinical – expert reports
		Clinical and non-clinical CTD Modules and study reports
		Preparation of posters for conference and information for patients
		Experience in a wide variety of indications for phase II studies

		Consultation and preparation of Canadian Regulatory Submission
		Submission and review of Research Ethics Board approvals for clinical studies
		Regulatory Maintenance: Annual Reports, SAE reports
		Investigator Brochures and regular updates
		Wide range of therapeutic areas and types of regulatory submissions
		Applying different approaches to support effective and timely resolution of regulatory issues
		Planning strategies for most effective and timely review and approval of regulatory submissions
		Development of Standard Operating Procedures
		Development and maintenance of Regulatory Tracking database

CMX ensures compliance and quality assurance with standards of good clinical practice (GCP) across the network. Our sites thrive on best practices levels of performance. We emphasize value in top quality service while maximizing customer satisfaction and decreasing costs. Our model increase subject recruitment and subject retention.

CMX provides monitoring services in accordance to Good Clinical Practice (GCP) Guidelines. Our in-house certified CRAs regularly perform following duties to maintain GCP/ICH regulations and guidelines to ensure consistency with CMX Standard Operating Procedures (SOP):

		Monitor investigator site to verify the accuracy of the data being submitted to the sponsor and to ensure the site is complying with the protocol, regulations and guidelines.
		Preparation of essential document review guidelines
		Protocol and Informed Consent Form reviews for compliance to GCP and SOPs
		Review of key deliverables (protocols, reports, datasets, etc.)

We ensure that each staff has the proper qualifications necessary to maintain the highest level of excellence in clinical research. These requirements include an RN/Bachelor degree in Biological Science, relevant industry experience, certifications, strong problem-solving skills, excellent organization and written communication skills, and above all, strong interpersonal skills to facilitate blending into company culture.

For all of our multi-center studies, CMX arranges meetings of study investigators, sponsors, and site staff. This meeting would introduce the study and its goals, review the study operational details, and provide an opportunity for investigators to interact with each other and with members of the sponsors’ and CRO teams.

CMX has a professional staff of in-house event/travel planners that are experienced in putting together important meetings. Arranging a meeting frequently includes multiple elements, such as travel, transportation arrangements and knowledge of meeting sites, hotel space, meeting rooms, meals and audio/visual requirements. CMX provides a one-stop-shop for these complex and time-consuming tasks.

Our professional staff has the industry knowledge and background to understand the challenges and opportunities in conducting a successful investigator meeting or professional event.

Some of our events in the past include:

		International and within Canada Investigator Initiation Meetings
		CMX Annual Conference
		CME events
		Medical Conferences
		Professional development seminars/workshops

Working with local Electronic Date Capture (EDC) providers, we provide customized Electronic Case Report Forms (e-CRFs) for Investigator sponsored and phase IV trials.

Our Site Enhancement Program was developed in 2004 to assist our study coordinators and investigators in furthering their professional role within clinical trials work. A number of elements are considered in the year end review of a site that determines CMX’s financial contribution towards an educational grant. These are in the form of site revenues and include the following points:

		Organization and staffing
		Physical set-up & Equipment
		Recruitment success into various trials and quality data
		Adherence to GCP + SOPs
		Communication with sponsors, other sites, SMO etc.
		Proactive nature of acquiring leads to studies
		Continuous education

Please Contact Via: sitemanagement@cmxres.com