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Pre Site Visit QuestionnaireManna Research (Montreal)1Site InformationSite locationManna Research (Montreal)175 Stillview Road, Suite 145Pointe Claire, QCH9R 4S3Contact Information:514 694-9940 phone514 694-5594 fax844-26-MANNA (62662) toll freeresearch@mannaresearch.com emailSpecific clinical studies of interest AllergyDepressionDermatologyDiabetesDigestive DisordersCholesterolInfectious DiseaseMen’s HealthPain & NeurologyObesityRespiratory DiseaseRheumatologyUrologyVaccinesWomen’s HealthPhase II - IV ExperienceDescription of site Private Clinical Research CentreMemberships Member of the Society for Clinical Research Sites (SCRS)Member of the Canadian Association of Independent Clinical Research (CAICR)Number of studies capable per site5 enrolling studies with 4 maintenance studiesHow long has the site been involved in clinical research?Site has been doing research for1 8 yearsMay not be distributed or reproduced without permission from LMC / Manna ResearchPage:1 of 6
SOP#: SOP-ADM-005Version #: 2.0Effective Date: 01Jun2013PSV Questionnaire Site: (Manna Montreal)PI has 20 years experience with clinical trialsHas the site been audited? Health Canada audit (March 2009) - fully compliantSponsor audits for highest enrolling - positive findings onlyEmergency response All staff are CPR certified annuallyLakeshore Hospital (2 minutes from the clinic)AED in the building2Study StaffPrincipal InvestigatorsLaurie Breger, MD, CCFP, MCC 18 years research experience 165 clinical trials: Respiratory, Cardiovascular, Gastointestinal, Obesity, Diabetes, Vaccines, Psychiatry,Osteoarthritis, Lipids, Women’s studies, Urology, Gout, AllergiesEducation1984199119781978Certification, College of Family Physicians of CanadaDiplomate of the National Board of Medical Examiners, USACollège Professionnelle des Medecins du QuebecLicentiate; Medical Council of t1998-present1979-presentPrincipal Investigator, Manna Research (formely Kells Medical Research Group)Associate Medical Director, Kells Medical Research GroupLecturer, McGill UniversityDirector, GBMC Medical Services Inc.General Practitioner Family Practice, Point Claire, QuebecJeannette Janzen, MD, CCFP 20 years research experience 165 clinical trials: Respiratory, Cardiovascular, Gastointestinal, Obesity, Diabetes, Vaccines, Psychiatry,Osteoarthritis, Lipids, Women’s studies, Urology, Gout, AllergiesEducation1988198719861980Family Medicine Residence, C.C.F.P., St. Mary’s HospitalRotating Internship, St. Mary’s HospitalM.D., University of SaskatchewanDiploma in Biblical Studies, Columbia Bible ipal Investigator, Manna Research Inc.Medical Director, Pre-Travel MedicineMay not be distributed or reproduced without permission from LMC / Manna ResearchPage:2 of 6
SOP#: SOP-ADM-005Version #: 2.0Effective Date: 01Jun2013PSV Questionnaire Site: (Manna sent1994-19981994-19971989-199319881988CHSLD, Chateau Sur La LacAssociate Medical Director, Kells Medical Research GroupPrivate Family Medicine Practice, GMF StillviewMinor Emergency, Statcare ClinicPalliative Care Unit, Chronic Geriatric Unit, Mount Sinai HospitalTreatment of snoring problems/Tracking of Sleep Apnea disorders, West Island Snoring ClinicHealth Services, John Abbott CollegeGeneral Health Locum, Dr. R. SawatskyGeneral Health Locum, Dr. D. FurlongNaveen Garg, MD 2 year research experience 15 clinical trials: Respiratory, Cardiovascular, Obesity, Diabetes, Lipids, Women’s studiesEducationSep 2011-PresentLevel 1: Certificate Course in Aesthetic Medicine - American Academy of Aesthetic Medicine, CaliforniaLevel 2: Diploma Course in Aesthetic MedicineAug 2011-May 2013Physician’s Executive MBA, Auburn University-College of Business, AuburnJul 2008-Jun2011Family Medicine Residency & Chief Resident - University of Connecticut/St. Francis Hospital, HartfordIntegrative Medicine ResidencySep 2004-Mar 2008Doctor of Medicine, Saba University School of Medicine, NetherlandsSep 2001-May2004Bachelor of Science, Physical Therapy, McGill University, MontrealAug 1999-May 2001D.E.C., Natural Sciences, John Abbott C ollege, MontrealAppointmentsMar 2017-PresentMar 2012-PresentMar 2012-PresentMar 2012-PresentMar 2012-PresentJul 2010-Jun 2011Jul 2008-Jun 2011Jul 2008-Mar 2008May 2003-Aug 2004Mar 2002-Mar 2004Principal Investigator/ Sub-Investigator, Manna Research Inc.President, Naveen Garg Medical Services Inc. , MontrealFamily Practice, GMF Stillview, MontrealWalk-in Physician, Statcare Walk-in Clinic, MontrealSports Medicine Physician, Concordia Physio Sport, MontrealChief Resident, Family Medicine Residency Program, University of Connecticut, HartfordUniversity of Connecticut, HartfordSt. Francis Hospital, Hartford,PGY 1-3: Family Medicine ResidentAsylum Hill Family Medicine Center, HartfordConnecticut Children’s Medical Center, HartfordMedical Student in Various Departments and Spcialities, Lincoln Medical & Mental Health CenterPhysiotherapist for Research on Stroke & Breast Cancer Patients, Royal Victoria Hospital, MontrealPhysiotherapy Student, McGill University Hospitals, MontrealInvestigator Accountability20% research, 80% clinic3Patient Population and RecruitmentNumber of patientsDatabase of 100,000 patientsMay not be distributed or reproduced without permission from LMC / Manna ResearchPage:3 of 6
SOP#: SOP-ADM-005Version #: 2.0Effective Date: 01Jun2013PSV Questionnaire Site: (Manna Montreal)Capability of screening databaseYes – able to note demographic information, medications, IICD-9 codes, medical history, lab values and medicaldocumentsCatchment areaMontreal, West IslandHow are subjects recruited to meet the agreed upon targets? Patient databaseClinic referralsGP & Specialist referral networkAdvertising - radio, newspaper,central toll free number and capability of central ad campaigns for allLMC Manna sitesCommunity engagement - public forums, pharmacy days, educational events & exposE-recruitment & social media campaigns – patient advocates & testimonials4EthicsEthics committee (local or central) Central EthicsWorked with IRB Services, Schulman, Quorum, WIRB, Veritas, Canadian Shield, Optimum, etc.Informed consent process See Manna Research SOPsGCP/ICH CompliantConfidentiality PIPEDA and CAI implementedCAI compliant5FacilitiesEquipment available Centrifuge (calibrated yearly)ECG machineweight scale (calibrated biannually)1 x -20 freezer2 x fridge for study medication purposes onlyManual blood pressure devicesAble to do PK analysis, injections & meal tolerance testsMay not be distributed or reproduced without permission from LMC / Manna ResearchPage:4 of 6
SOP#: SOP-ADM-005Version #: 2.0Effective Date: 01Jun2013PSV Questionnaire Site: (Manna Montreal)Office hours Monday - Friday (7:30 am - 6:00 pm)Weekends as neededMonitoring space 3 rooms dedicated to monitoringPhone, analog, wireless and broadband accessAccess to a fax and photocopy machineLMC Manna Research SOP ERB & HC reviewedSource documents LMC l Manna Research specific templates for source creation and study specific logsDrug accountability and storage Secured and Locked medication room, Fridges and FreezerTemperature monitored twice daily (min, max and average temperatures). Space for un-blinded medicationpreparationeCRF experience INFORMRDCORACLEBIRTMedidata RAVEDatalabsMedrioIVRS experience ClinphoneClintrakEndpointICONFisher Clinical ServicesImpalaPerceptiveAlmacCardinalData storage In house: Lead study coordinator’s office Paper charts Electronic medical records (printed paper copy, certified copy) Long term storage: Iron Mountain x 25 yearsMay not be distributed or reproduced without permission from LMC / Manna ResearchPage:5 of 6
SOP#: SOP-ADM-005Version #: 2.0Effective Date: 01Jun2013PSV Questionnaire Site: (Manna Montreal)Address: Records Management Division1655 FleetwoodLaval, Quebec H7N 4B26ContractSites usual overhead 30% overheadLegal Name LMC Clinical Research Inc. d.b.a. Manna ResearchSite Name Manna Research (Montreal)Sites turnaround 1-2 week turnaroundBudget Negotiations Budgets and Contracts: Nichelle FarrellEmail: nichelle.farrell@lmc.caPhone: 416-645-2928 ext 9205Fax : 416-645-2931Regulatory Documentation Regulatory Specialist: Dennis KhaEmail: dennis.kha@lmc.caPhone: 416-645-2928 ext 9370Fax: 416-645-2931Address: 1929 Bayview Avenue, Suite 106Toronto, Ontario M4G 3E8May not be distributed or reproduced without permission from LMC / Manna ResearchPage:6 of 6
IVRS experience Clinphone Clintrak Endpoint ICON Fisher Clinical Services Impala Perceptive Almac Cardinal Data storage In house: Lead study coordinator's office Paper charts Electronic medical records (printed paper copy, certified copy) Long term storage:
