Bilingual Contract CLINEMETRICA Corporate Profile Founded in 1989 by by lbv11407

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									  CLINEMETRICA

  Corporate Profile
  Founded in 1989 by faculty and research staff from the Division of Clinical
  Epidemiology, the Montreal General Hospital and McGill University,
  Clinemetrica is a fully bilingual Contract Research Organization applying the
  highest academic standards while meeting the needs of its clients in government
  and industry.
  Our qualified personnel are committed to innovation, professionalism, and
  ethical rigour. Our reputation has been built on experience, performance, and
  responsiveness to each client’s needs, and a corporate commitment to exceed
  expectations.

  We provide personalized solutions to help our clients meet their goals in a timely
  and cost-effective manner. Services include protocol development and study
  design, data management, biostatistics and outcomes research, as well as data
  communication and publication.

  In order to maintain its high standards, Clinemetrica is equipped with a
  comprehensive Quality Assurance System including a full set of Standard
  Operating Procedures (SOPs) and internal audit processes that comply with ICH
  and FDA regulations.


                      Our Vision
                      To be a specialized Contract Research Organization
                      with the highest academic standards.

                      Mission
                      To enhance knowledge by providing quality
                      research services that exceed clients’ expectations
                      while maintaining academic integrity.




                                                          Quality data management when you need to know the truth
1900 Sherbrooke Street West Suite 500 Montreal, Quebec H3H 1E6Tel. (514) 846-7973 Fax (514) 846-1447 Email: contact@clinemetrica.com
                contact@clinemetrica.com<mailto:contact@clinemetrica.com>contact@clinemetrica.com
CLINEMETRICA

Protocol Development
and Study Design
The research team at Clinemetrica is known for its creative multidisciplinary
approach to clinical research. Using innovative methods, we have acquired
extensive experience in managing clinical studies using a variety of study
designs and settings. Our team has the training and expertise needed to
develop the optimal protocol and study design for each specific project.

Our services include:


          ● Literature review and meta-analysis
          ● Study design
                 - Large multi-center trials
                 - Hospital and non hospital-based trials
                 - Prospective (randomized controlled trials)
                 - Cross sectional (surveys, prevalence, questionnaire validation)
                 - Retrospective (case-control studies)
                 - Parallel groups (double blinded or not)
          ● Statistical planning
                 - Sample size calculation
                 - Randomization
                 - Power calculations
          ● Case Report Form (CRF) design
          ● CRF completion guidelines
          ● Informed Consent Form (ICF)
          ● Newsletters
          ● Study Reports




                                                         Quality data management when you need to know the truth

1900 Sherbrooke Street West Suite 500 Montreal, Quebec H3H 1E6Tel. (514) 846-7973 Fax (514) 846-1447 Email: contact@clinemetrica.com
    CLINEMETRICA

    Data Management
    Clinemetrica’s approach is to provide clinical data management services that
    are customized to each client’s specific requirements. We also ensure our
    solutions are cost-effective, secure and compliant with regulatory agencies.

    Clinemetrica’s skilled research team is able to deal efficiently with all aspects
    of data management from database design to database lock and transfer.
    Furthermore, the support and flexibility of the best available software such as
    Oracle Clinical and Thesaurus Management System allow us to effectively
    handle both traditional and electronic data capture, as well as provide seamless
    query management.

    Our services include:


              ● Data Management Plan
              ● Database Design
                  (High level programming and streamlined data entry screens)
              ● Data Validation Plan
              ● Double Data Entry
              ● Medical Coding
                  (MedDRA, Who Drug or client-specified dictionaries)
              ● Data Validation and Query Management
                  (Thorough edit check programming)
              ● Central Lab Database Imports
              ● Database Lock and Audit
              ● Database Documentation
                  (Complete audit trail with reporting)




                                                       Quality data management when you need to know the truth

1900 Sherbrooke Street West Suite 500 Montreal, Quebec H3H 1E6Tel. (514) 846-7973 Fax (514) 846-1447 Email: contact@clinemetrica.com
   CLINEMETRICA

   Biostatistics and
   Outcomes Research
   Clinemetrica has a dedicated biostatistics and outcomes research division. The
   multidisciplinary team includes statisticians, clinical epidemiologists,
   psychologists and health economists. We provide services that are customized
   to the clients’ needs and we have the expertise and flexibility to respond
   quickly to necessary changes to the study protocol and CRF, or issues
   regarding protocol deviations. Whether developing a detailed statistical
   analysis plan prior to starting data collection or responding to impromptu
   requests for additional analysis, the focus remains the same, a comprehensive
   data analysis where all the possible successful outcomes are considered.

   Our services include:



             ● Statistical Analysis Plans

             ● Data monitoring and safety reviews

             ● Programming support for efficient data entry

             ● Psychometric and quality of life measurement

             ● Statistical consulting

             ● Health economic analyses




                                                             Quality data management when you need to know the truth

1900 Sherbrooke Street West Suite 500 Montreal, Quebec H3H 1E6Tel. (514) 846-7973 Fax (514) 846-1447 Email: contact@clinemetrica.com
     CLINEMETRICA

     Data Communication
     and Publication
     Our team of medical writers has over 20 years of experience in preparing and
     presenting award-winning research at international scientific conferences.
     Their experience in the various aspects of clinical research, combined with an
     in-depth knowledge of therapeutics, ensures documents that meet the highest
     scientific standards. Close cooperation between on-site staff and external
     experts gives our writers access to a fully integrated network of up-to-date
     expertise and authoritative peer review.

     Our services include:


               ● Medical and scientific literature reviews

               ● Study Protocol Development

               ● Interim and final Study Reports (with tables and graphs)

               ● Statistical Reports

               ● Abstract submissions and Poster design (graphics and visuals)

               ● Peer review publications

               ● PowerPoint presentations




                                                            Quality data management when you need to know the truth
1900 Sherbrooke Street West Suite 500 Montreal, Quebec H3H 1E6Tel. (514) 846-7973 Fax (514) 846-1447 Email: contact@clinemetrica.com
   CLINEMETRICA

   Selected Publications
   Grover SA, Abrahamowicz M, Joseph L, Brewer C, Coupal L, Suissa S. The benefits of treating hyperlipidemia to
        prevent coronary heart disease:   Estimating changes in life expectancy and morbidity.            JAMA
        1992;267(6):816-822.

   Hamilton V, Racicot FE, Zowall H, Coupal L, Grover SA. The cost-effectiveness of HMG-CoA reductase inhibitors
        to prevent coronary heart disease: Estimating the benefits of raising HDL. JAMA 1995;273(13):1032-1038.

   Grover SA, Lowensteyn I, Esrey KL, Steinert Y, Joseph L, Abrahamowicz M. How accurately do Canadian
        physicians assess the coronary risk of their patients? The preliminary results of the Coronary Health
        Assessment Study (CHAS). BMJ 1995;310:975-978.

   Grover SA, Coupal L, Hu X-P. Identifying adults at increased risk of coronary disease: How well do the current
        cholesterol guidelines work? JAMA 1995;274:801-806.

   Grover SA, Paquet S, Levinton C, Coupal L, Zowall H. Estimating the benefits of modifying risk factors of
        cardiovascular disease: A comparison of primary vs secondary prevention. Arch Intern Med 1998;158:655-
        662.

   Grover SA. Gambling with cardiovascular risk: Picking the winners and losers. [Invited Editorial] The Lancet
        1999;353:254-255.

   Lalonde L, Clarke AE, Joseph L, Grover SA and the Canadian Collaborative Cardiac Assessment Group.
        Conventional and chained standard gamble in the assessment of coronary heart disease prevention and
        treatment. Med Decis Making 1999;19:149-156.

   Grover SA, Coupal L, Zowall H, Rajan R, Trachtenberg J, Elhilali M, Chetner M, Goldenberg L. The clinical
        burden of prostate cancer in Canada: forecasts from the Montreal Prostate Cancer Model. Can Med Assoc J
        2000;162:977-83.

   Grover SA, Coupal L, Zowall H, Rajan R, Trachtenberg J, Elhilali M, Chetner M, Goldenberg L. The economic
        burden of prostate cancer in Canada: forecasts from the Montreal Prostate Cancer Model. Can Med Assoc J
        2000;162:987-92.

   Grover SA, Coupal L, Zowall H, Dorais M. The cost-effectiveness of treating hyperlipidemia in the presence of
        diabetes: Who should be treated? Circulation 2000;102:722-727.

   Grover SA, Coupal L, Zowall H, Alexander CM, Weiss TW, Gomes DRJ. How cost-effective is the treatment of
        dyslipidemia in patients with diabetes but without cardiovascular disease? Diabetes Care 2001;24:45-50.

   Lalonde L, Clarke A, Joseph L, Mackenzie T, Grover SA and the Canadian Collaborative Cardiac Assessment
        Group. Health-related quality of life with coronary heart disease prevention and treatment. J Clin Epidemiol
        2001;54:1011-1018.

   Grover SA, Ho V, Lavoie F, Coupal L, Zowall H, Pilote L. The importance of indirect costs in primary
        cardiovascular disease prevention: Can we save lives and money with statins? Arch Intern Med 2003;163:333-
        339.

   Grover SA, Dorais M, Coupal L. Improving the prediction of cardiovascular risk: Interaction between LDL and
        HDL cholesterol. Epidemiol 2003;14;315-320.




1900 Sherbrooke Street West Suite 500 Montreal, Quebec H3H 1E6Tel. (514) 846-7973 Fax (514) 846-1447 Email: contact@clinemetrica.com

								
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