A Clinical Contract
Research Organization providing
complete and flexible clinical
management services.

January 20, 2016

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About Us

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Overview

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.

Management

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.

Strategic Alliances

MedQualis has now the capacity to conduct clinical studies in Canada and Europe.

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Services

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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.

Why working with MedQualis:

Early Stage: BA/BE & Phase I

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.

Type of studies

  • •  Standards BE/Ba Studies
  • •  Food effect, Age Effect, Gender effect studies
  • •  Steady State studies
  • •  Drug/Drug Interaction studies
  • •  Biological/ Biosimilar studies
  • •  QTc studies
  • •  Single ascending dose (SAD) and
    Multiple ascending dose (MAD) studies
  • •  505 (b) 2 studies
  • •  Speciality in Dermatolgy:
    • ○  Cummulative Irritation study
    • ○  Phototoxicity Patch test study
    • ○  PhotoAlllergic Skin reaction study
    • ○  Repeat Insult patch test study

Type of study by route of administration

BE Studies

Site Management & Monitoring

Monitoring and site visits
  • •  Site Selection / Feasibility Assessment;
  • •  Site Initiation Visits (on site or phone visit);
  • •  Site Management & Monitoring activities;
    • ○  Development of Monitoring Plan;
    • ○  Proactive monitoring approached while on site;
    • ○  Source Data Verification (SDV);
    • ○  Preparation of Monitoring reports and CAPA;
  • •  Site Close Out Visits;
  • •  Quality Assurance Audit
Site Management & Monitoring

Statistics

  • •  Study Design (protocol review, sample size calculation)
  • •  Statistical Analysis
  • •  PK/PD Studies and Bioequivalence Studies
  • •  Pre-Clinical Studies
  • •  Analytical (e.g. transfer of methods, validation)
  • •  Sample Size Adaptive Sequential Design
  • •  Quality of Life and Patient Reported Outcome
  • •  Statistical Support in Regulatory Submission
    (FDA, Health Canada, EMA)
  • •  Statistical Training
  • •  Biometrics (data management & statistical process)
PK/PD studies

Our team

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.

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Late Stage: Phase II to Phase IV

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.

Study start-up

Our qualified team will ensure that all the studies are initiated in a timely manner, promptly and efficiently.

The pre-study activities include:
  • •  CRF design and development
  • •  Site and Investigator selection
  • •  Investigator budget negotiations
    and contracting
  • •  On-site qualification assessments
  • •  Investigator meeting planning
  • •  Site management
  • •  Medical Writing
  • •  Regulatory submission
  • •  ERB review
Site Management
  • •  Investigator recruitment
  • •  First contact
  • •  Sites evaluation
  • •  Site set-up
Medical Writing

MQ provides full service medical writing support for regulatory documents from clinical study protocols to regulatory submission documents

  • •  Protocol development
    • ○ MQ can provide protocol development services for all phases of clinical research in accordance with ICH standards. Protocols may be developed in their entirety from the stage of an initial concept, incorporating objectives, hypotheses, study design, inclusion exclusion criteria and detailed instructions for all study visits and procedures, in addition to standardized sections on safety reporting, protection of subjects and confidentiality. Alternatively, MQ can provide medical review and editing of protocols which are already provided in draft stage by the Sponsor.
  • •  Clinical Study Reports (CSRs)
    • ○ MQ will develop comprehensive interim and final clinical study reports in accordance with its standard internal templates written in accordance with ICH guidelines.
  • •  Statistical reports
  • •  Study reports (clinical and non-clinical)
  • •  Integrated summaries of safety
  • •  Integrated summaries of efficacy
  • •  Research proposals
Regulatory submissions

MedQualis can assist you with the current requirements for all types of regulatory submissions, including Clinical Trial Applications (CTAs).

Ethics Review and approval

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 local requirements.

Community sites normally require central IRB review, and MedQualis interacts with many highly respected national clinical review boards for this purpose.

Project Management

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:

  • •  Project planning, tracking and reporting
  • •  Overall project supervision
  • •  Regular project meetings/teleconferences in order to review/plan the project scope, assumptions, timelines and activities
  • •  Primary contact with client/sites/vendors
  • •  Timelines and budget management
  • •  Maintenance of the project information flow in a timely and proactive manner
  • •  Preparation of weekly/monthly/quarterly status reports
  • •  Vendor Management and Payments

Biometrics Services

Data Management

Medqualis provides sponsors with the possibility of using the electronic or paper-based data collection formats:

  • •  Electronic case report forms: Medrio platform is used for the EDC studies. The electronic case report forms are programmed in Medrio to encompass a broad range of online point of entry quality assurance checks, detecting potential errors at the point of entry and facilitating the collection of clean data.
  • •  Paper format: MedQualis can employ hard-copy case report forms provided by the sponsor or develop these forms internally if required. MedQualis will design the content and the format of the CRFs based on the study protocol, as well as coordinate the printing, collation and distribution of CRF binders to the designates sites.
Statistics
  • •  Study Design (protocol review, sample size calculation)
  • •  Statistical Analysis
  • •  Phase 1 to 4 Clinical Studies
  • •  Sample Size Adaptive Sequential Design
  • •  Quality of Life and Patient Reported Outcome
  • •  Statistical Support in Regulatory Submission (FDA, Health Canada, EMA)
  • •  Statistical Training
  • •  Biometrics (data management & statistical process)

Monitoring

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.



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Expertise

Therapeutic Expertise
  • •  Neurosciences: depression, anxiety, epilepsy and stroke
  • •  Devices: injection device for diabetics, stent for coronary artery diseases
  • •  Cardiology: hypertension, unstable angina, acute myocardial infraction, device study [stent for coronary artery disease]
  • •  Endocrinology: diabetes, growth hormone, women’s health
  • •  Urology: erectile dysfunction, urinary incontinence, BPH
  • •  Dermatology: psoriasis, psoriasis arthritis, sunscreen, skin cancer, skin aging, scars, atopic dermatitis, acne, androgenic alopeciea, onychomycosis
  • •  Gastroenterology: gastric ulcer, delayed gastric emptying, reflux, dyspepsia, H. pylori
  • •  Respiratory: asthma, COPD, rhinitis
  • •  Ophthalmology: cytomegalovirus in immunocompromised subjects
  • •  Anesthesiology: epidural following bowel resection
  • •  Infectiology: influenza
  • •  Transplant: Renal transplantation
  • •  Rheumatology: Rheumatoid arthritis, osteoarthritis
  • •  Oncology: Breast cancer, bladder cancer
  • •  Natural Health Product.
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Thank you for
your interest in
career opportunities
at MedQualis!

Contact

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Medqualis
1240 Beaumont Ave.
Suite 204
Mont-Royal, QC
H3P 3E5, Canada
Tel : 514-526-0626
Fax : 514-526-1028
info@medqualis.com

Careers

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: bmarcheterre@medqualis.com.