Apotex clinical trials
Additional Search Options. Create Alert. About Apotex Inc. Job Summary. Job Responsibilities. Participates in the vendor selection process through the completion of request for proposals RFP and the negotiation and management of external vendor contracts including confidentiality agreements and statements of work. Leads the set up and execution of complex, mulitcentre trials with time frames of 12 to 24 months applying general principles of Project Management. This includes, but is not limited to, working closely with the 3rd party Contract Research Organization CRO or 3rd party Packaging CRO to: Assist in site identification and qualification Lead document reviews with stakeholders for various plans e.
Ensure timely delivery of the Investigational Medicinal Products and appropriate retention quantities to the clinical sites Assist in the timely delivery of clinical trial enrollment Manage and mitigate issues at clinical trial sites, with escalation, when required Manage the budget Lead clinical data reviews with internal stakeholders and assist in the timely delivery of database locks Ensure inspection readiness at the clinical sites Develops, fosters and maintains strong relationships with external providers in the field through participation in the selection and management of outsourcing and provider contracts.
Acts as a specialized resource to team members around potential courses of action for complex issues. Participates on the RFP evaluation committee in the review and selection of the best vendor for the applicable project.
Assists in the evaluation of external vendor performance for suitability of future outsourcing activities. Our Clinical Operations Facility has over 8, square meters of space with state-of-the-art clinical and bioanalytic labs and is capable of housing over subjects.
We have a staff of approximately , trained to international standards for clinical studies. Skip to main menu Skip to main content. Apotex Worldwide. Our biosimilar portfolio, focused on oncology, is unaffected by the demand for API, and we do not foresee risks with these products.
We are working closely with suppliers, monitoring for potential disruptions to our global supply chain. In addition to securing supply for the short term, we maintain business continuity plans to address the longer-term needs of patients who depend on our products. We are continually assessing supply levels as well as product demand in order to make adjustments to our orders as well as manufacturing and distribution schedules as needed. Additionally, we are the largest API producer in Canada, and this also helps to mitigate the risk.
Apotex has a long history of supporting communities around the world in times of need. This time is no different. To date, we have made multiple donations of Hydroxychloroquine to clinical trials being conducted within Canada. Read more about one study focused on examining whether or not hydroxychloroquine prevents infection of COVID in front-line healthcare employees. We have also donated much needed medical supplies to affected areas.
Apotex donated two million dosages of hydroxychloroquine to the Canadian federal government for current and future COVID related clinical trials and a portion will be used as part of National Emergency Strategic Stockpile.
Researchers in Canada are encouraged to contact Apotex if they require supply of hydroxychloroquine for COVID related clinical trials at hcqdonations apotex. We are using our technical expertise and manufacturing capability at our Apotex Pharmachem facility to produce and donate hand sanitizer in support of frontline workers in community agencies and healthcare facilities fighting COVID within Ontario.
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