> MedQualis Participation at the EADV in Istanbul
Founded in 2002, MedQualis is an established Clinical Contract Research Organization (CRO) providing complete and flexible research services to the pharmaceutical, biotech, medical device, Biologics, and Natural Health Product industries.
Brigitte Marcheterre received her Baccalaureate in Sciences in 1992 and her Master Degree at the University of Montreal in 2006. She has more than 20 years of experience in the pharmaceutical industry. Her broad experience in the research field includes many responsibilities, which evolved throughout the years. She commenced her career as a Clinical Research Associate located at the Eli Lilly head office in Toronto where she mastered monitoring duties and project management responsibilities for more than four years. Afterwards, she moved to a Clinical Scientist position where her responsibilities included overseeing Third Party Organization, Global and Canadian Standard Operating Procedure writing. She concluded her career with Eli Lilly leading business development and strategic planning. In 2001, she joined Innovaderm Research as the Director of Clinical Operations and has been in managing position since then. MedQualis was founded in 2002.
MedQualis has now the capacity to conduct clinical studies in Canada and Europe.
We are specialized in both the management and monitoring of clinical trials from phase I to IV in North America and Europe and monitoring of Phase 1, BE/BA studies in Canada, United States and in India.
With more than 390 studies monitored to date ranging from regular BE, to steady state and more, MedQualis is the only CRO in Canada with this level of expertise! Should you be looking for all PKs monitoring or just one type of visit, please contact us, you will be amazed by our knowledge, expertise and flexibility, but mainly we will know what you are talking about, BE studies being our core expertise.
MedQualis has a full set of SOPs specially written for BE/ BA studies along with all forms. We have had the chance to have many audits during the years, and these have helped us to continuously improve our SOPs.
Our early stage monitoring services are provided by monitors who have over 10 years of experience in monitoring and managing Phase 1, BE/BA studies or have graduated with a Master Degree in Drug development. They are highly qualified, knowledgeable professionals with extensive experience dedicated to early stage studies. The sponsors have the opportunity to review any profile prior to approving monitoring personnel for their study. You can trust an effective and extremely thorough monitoring.
Offering a highly skilled clinical research team, we focus on quality, dedication and flexibility. Our professionals are located in Canada and in Europe via strategic alliance. During the years we have managed more than 30 clinical projects with thousands of subjects enrolled.
Our qualified team will ensure that all the studies are initiated in a timely manner, promptly and efficiently.
MQ provides full service medical writing support for regulatory documents from clinical study protocols to regulatory submission documents
MedQualis can assist you with the current requirements for all types of regulatory submissions, including Clinical Trial Applications (CTAs).
MedQualis supports academic sites with submission of applications to their local Institutional Review Board.
We can provide you with Consent Form templates and other necessary documents which may be customized to meet
Community sites normally require central IRB review, and MedQualis interacts with many highly respected national clinical review boards for this purpose.
Medqualis provides project management support for Phase II through IV trials in all major therapeutic indications.
Our project managers are responsible to manage and oversee the conduct of clinical trials from initiation to
completion of report and publication and ensure the on-time and on-budget performance.
Also, they oversee the study process to ensure adherence to protocol, SOPs, GCP/ICH Guidelines, applicable regulatory requirements, and other documentation requirements, including: Review, track, and manage study documents (e.g., eClinical reports, study supplies, study drug shipments, ICFs, and enrollment logs) for completeness and accuracy.
Our project managers excel in providing the following services for clinical research studies:
Medqualis provides sponsors with the possibility of using the electronic or paper-based data collection formats:
The importance of monitoring has been lately highlighted by the many FDA Warning letters to this effect. The validity of the data sources and the investigator compliance to study protocol are very significant to the success of a clinical trial.
MedQualis experienced team of professionals can assess the level of source data verification (SDV)
required, to balance financial constraints with scientific and data integrity.
Based on the study phase, on your study objective and your preference of SDV, we can
custom a monitoring plan to suit your needs from 100% SDV to a more customized trigger approach.
MedQualis has also integrated the Risk Base monitoring approach.
Thank you for your interest in the career opportunities at Medqualis. We are continuously looking for dynamic and talented people, people eager to learn and ready to deliver quality results. You can always submit your resume and cover letter for general consideration to the attention of: Brigitte Marcheterre at: firstname.lastname@example.org.