Advertisement

Navigating the clinical trial pathway: Conception, design, execution, and results dissemination

      Dr Sampalis is founder, Chief Executive Officer, and Chief Scientific Officer of JSS Medical Research Inc, founded in 1997. He is a tenured professor of Surgery and Epidemiology & Biostatistics of McGill University, the University of Montreal and University of Laval. Recognized as a leading clinical epidemiologist and one of the top trauma researchers in Canada, he possesses extensive expertise in health services research, clinical trials, and offers services as a Research and Epidemiological Consultant for numerous pharmaceutical companies, hospitals and government organizations and agencies.
      Mrs. Watson holds a M.Sc. in Pharmacology from Dalhousie University, and a B.Sc. from the University of Western Ontario. Her experience extends to all facets of the CRO business, and multiple therapeutic areas. She co-founded, in 1992, Integrated Research Inc, a full-service contract research organization, and served as its President and Chief Executive Officer, until merging with JSS Medical Research Inc in 2014. Mrs. Watson currently holds the position of Chief Business Officer, and is head of the business development team.
      Mrs. Boukas has been working with the JSS Medical Research team since its inception in the 1990s. She holds a B.A. in Psychology from McGill University with training in Epidemiology and Biostatistics, and is certified by the Society of Clinical Research Associates (SOCRA) as a Certified Clinical Research Professional (CCRP). She has over 25 years’ of experience in medical research management. Currently Chief Operations Officer, Mrs. Boukas has been essential in structuring and implementing programs at JSS Medical Research Inc to facilitate project management, site recruitment, data capture and study tracking.
      Mrs. Boukas holds a B.A. from McGill University, a Certificate in Technical Communications from Concordia University and has received compliance training from SNC Lavalin Pharma (SLP) and SOCRA. She has over twenty-five years’ experience in research. Joining JSS Medical Research Inc in 1998, she currently holds the position of Executive Director of Quality Assurance (QA) where she developed and maintains the QA Program since 2004. The QA Program supports clinical studies conducted in Canada, Latin America, India and Europe.
      Mrs. Harvey holds a B.Sc. in Biochemistry from the Université du Québec à Montréal and a M.Sc. in Biology from McGill University. With 20 years’ experience in the pharmaceutical industry, she has held positions in both Commercial and Medical departments. Mrs. Harvey currently holds the position of Director, Clinical Operations at JSS Medical Research Inc, functionally and operationally overseeing a team of project and data managers in the development and implementation of clinical studies.
      Dr Machado obtained his medical degree from the University of Pune, India. He has over 20 years’ experience in multinational pharmaceutical, CRO, Bioequivalence & Phase I and Site Management Organizations, working in several therapeutic areas and phase of studies. As a founder of Venn Life Sciences, Dr Machado served as Chief Operating Officer, until joining JSS Medical Research Inc in 2011, where he is currently Vice-President, Global Operations & Integration. In addition to overseeing global operations, he is responsible for global expansion and integration of JSS Medical Research Inc through acquisitions and mergers.
      Mr. Bordeleau holds a B.Sc. in Biochemistry from the University of Guelph and an MBA from HEC Montreal. He has over 20 years’ experience in the pharmaceutical industry, including laboratory and IT research, healthcare marketing support, and IT team management. As Global Director of information Technology at JSS Medical Research Inc, Mr. Bordeleau leads a team of programmers as well as network, database and system administrators who specialize in developing, maintaining, and most importantly, improving, key software, clinical systems, infrastructure, and business processes.
      Dr Rampakakis received his Ph.D. from the Department of Biochemistry from McGill University, and obtained post-doctoral training, also at McGill, in Pharmacoepidemiology. With over 15 years’ experience in scientific research, he has contributed in the conception, design, analysis and interpretation of several large scale, national and international, registration and observational studies. He currently holds the position of Vice President of Scientific Affairs at JSS Medical Research Inc, overseeing a team of biostatisticians, epidemiologists, physicians, medical writers, and health economists.
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Surgery
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Bellary S.
        • Krishnankutty B.
        • Latha M.S.
        Basics of case report form designing in clinical research.
        Perspectives Clinical Research. 2014; 5: 159-166
      1. Hufford MR, Stone AA, Shiffman S, Schwartz JE, Broderick JE. Paper vs. electronic diaries: compliance and subject evaluations. 2002. Applied Clinical Trials, 38–43 Available from: http://www.appliedclinicaltrialsonline.com/.

        • Ring A.E.
        • Cheong K.A.
        • Watkins C.L.
        • Meddis D.
        • Cella D.
        • Harper P.G.
        A randomized study of electronic diary versus paper and pencil collection of patient-reported outcomes in patients with non-small cell lung cancer.
        Patient. 2008; 1: 105-113
      2. US Department of Health and Human Services; Food and Drug Administration; Center for Devices and Radiological Health; Center for Biologics Evaluation and Research. Guidance for industry and Food and Drug Administration staff—medical device data systems, medical image storage devices, and medical image communications devices. Available from: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm401996.pdf.

      3. US Department of Health and Human Services; Food and Drug Administration. Guidance for industry—computerized systems used in clinical investigations. Available from: http://www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf.

      4. US Department of Health and Human Services; Food and Drug Administration. Guidance for industry—patient-reported outcome measures: use in medical product development to support labeling claims. Available from: http://www.fda.gov/downloads/Drugs/.../Guidances/UCM193282.pdf.

      5. Clinical Data Interchange Standards Consortium. CDISC SDTM/ADaM Pilot Project. Available from: http://www.cdisc.org/cdisc-sdtm/adam-pilot-project.

      6. Clinical Data Interchange Standards Consortium. FDA final binding guidance on standards now available. Available from: https://www.cdisc.org/FDA-Final-Binding-Guidance-on-Standards.

      7. World Health Organization. WHO policy perspectives on medicines- pharmacovigilance: ensuring the safe use of medicines. 2004. Available from: http://apps.who.int/iris/bitstream/10665/68782/1/WHO_EDM_2004.8.pdf.

        • Dave V.S.
        Current trends in pharmacovigilance.
        J Pharmacovigil. 2012; 1: 108
        • Elhassan G.O.
        Pharmacovigilance: clinical perspectives towards patient safety.
        J Pharmacovigil. 2005; 3: 2
        • Agrawal P.
        Drug discovery and development: an insight into pharmacovigilance.
        J Pharmacovigil. 2014; 2: 2
        • Preda A.
        Pharmacovigilance in the new millennium: challenges, opportunities and new directions.
        J Pharmacovigilance. 2013; 1: e106
      8. US Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research. Guidance for industry—good pharmacovigilance practices and pharmacoepidemiologic assessment. Guidance for industry good pharmacovigilance practices and pharmacoepidemiologic assessment. Available from: http://www.fda.gov.

      9. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Efficacy guidelines—ICH guidelines: E6 good clinical practice. Available from: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html.

      10. Center Watch. Survey of investigative sites 2007. Available from: http://www.centerwatch.com/.

        • Cook T.D.
        • DeMets D.L.
        Introduction to statistical methods for clinical trials.
        CRC Press, Boca Raton2007
        • Carter R.L.
        • Scheaffer R.L.
        • Marks R.G.
        The role of consulting units in statistics departments.
        American Statistician. 1987; : 260-264
      11. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Efficacy guidelines—ICH guidelines: E9 statistical principles for clinical trials. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf.

      12. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Efficacy guidelines—ICH guidelines: E3 structure and content of clinical study reports. Available from: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E3/E3_Guideline.pdf.

        • Doshi P.
        • Jefferson T.
        Clinical study reports of randomized controlled trials: an exploratory review of previously confidential industry reports.
        BMJ Open. 2013; 26: 3
      13. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use. Mutlidisciplinary guidelines—M4: the common technical document. Available from: http://www.ich.org/products/ctd.html.

      14. Food and Drug Administration. Guidance for industry. Part 11, electronic records; electronic signatures—scope and application. Available from: http://www.fda.gov/RegulatoryInformation/Guidances/ucm125067.htm.