Elke Bass

Senior Manager, Reporting And Quality Control at BioPharma Services

Elke Bass is an accomplished professional in the bioanalytical field with over two decades of experience in quality control, reporting, and regulatory compliance. Currently serving as Senior Manager of Reporting and Quality Control at BioPharma Services Inc., Elke has a proven track record of overseeing the creation and delivery of high-quality bioanalytical study and method validation reports, ensuring adherence to strict regulatory guidelines. Previous roles include managerial positions at various prominent organizations such as Bioanalytical Laboratory Services, PRACS Institute, and Cetero Research, where Elke successfully led teams and enhanced reporting processes to meet current eCTD specifications. Elke’s educational background includes an Honors Bachelor of Science degree from the University of Toronto and a wide range of continuing education courses, highlighting a commitment to professional development in the field.

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BioPharma Services

BioPharma Services Inc. is a full-service Contract Research Organization (CRO) specializing in Phase I/IIa, Bioequivalence, Human Abuse Liability, PET Imaging and Psychedelic Studies. With over 17 years of industry experience, and a primary research facility in Toronto, Canada, our team of experts are dedicated to delivering superior quality service and reliable research results. BioPharma Services offers in-house, GLP/GCP preclinical and clinical bioanalytical services, featuring LC-MS/MS technology at our Toronto facility. We prioritize ethical subject recruitment and comply with all major international regulatory bodies, including the FDA, Health Canada, and ANVISA. We have been successfully inspected by all major regulatory bodies, and are dedicated to building and maintaining long-lasting relationships with our Global clients through superior quality service, timely and reliable research results. Highlights of our experience: → State-of-the-art Clinical facility in Canada with over 150 bed capacity → 99% enrolment for all Phase I studies with a 95% completion rate → Timely study start up: 30 Day CTA, Weekly IRB/Ethics review → 20,000+ active subject database of patients, special populations & healthy volunteers → Full service capabilities: Regulatory, Scientific and Medical Affairs, Comprehensive Project Management, Data Management, Biostatistical Analysis with CDISC data standards (SDTM and ADaM datasets), Medical Writing and more.


Headquarters

Toronto, Canada

Employees

201-500

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