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Pre Site Visit QuestionnaireManna Research (Toronto)1Site InformationSite locationManna Research (Toronto)2291 Kipling Avenue, Unit 117BToronto, ONM9W 4L6Contact Information:416 740-2895 phone416 740-4517 fax844-26-MANNA (62662) toll freeresearch@mannaresearch.com emailSpecific clinical studies of interest AllergyDepressionDermatologyDiabetesDigestive DisordersCholesterolInfectious DiseaseMen’s HealthPain & NeurologyObesityRespiratory DiseaseRheumatologyUrologyVaccinesWomen’s HealthPhase I - 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 site8-10 enrolling studies with 20-25 maintenance studiesHow long has the site been involved in clinical research?Site has been doing research for 21 yearsMay not be distributed or reproduced without permission from LMC / Manna ResearchPage:1 of 5
SOP#: SOP-ADM-005Version #: 2.0Effective Date: 01Jun2013PSV Questionnaire Site: (Manna Toronto)PI has 5 years experience with clinical trialsHas the site been audited? Health Canada audits (January 2009, October 2014) - fully compliantFDA audit (January 2015) compliant, no 483Sponsor and ethics board audits for highest enrolling - positive findings onlyEmergency response All staff are CPR certified annuallyEtobicoke General Hospital (3.1km)Crash cart, oxygen, and defibrillator on site2Study StaffPrincipal InvestigatorAzhar Toma, MD, LMCC, CCFP 5 years research experience 85 clinical trials: Primary CareEducation20102002Certification in Family Medicine, College of Family Physicians of CanadaBachelor of Medicine & Bachelor of Surgery (MB ChB), Baghdad -20132011-20122005-20112005-20112004- 2005Principal Investigator, Manna Research, Etobicoke, OntarioFamily Physician, Kipling Heights Medical Center, Etobicoke, OntarioFamily Physician, Bloom Clinic, Brampton, OntarioFamily Physician, Bramalea Community Health Center, Brampton, OntarioFamily Physician, Bramalea Community Health Center, Brampton, OntarioFamily Physician, Newfoundland & LabradorGeneral Practitioner, Baghdad, IraqSub Investigator:Sheldon Finkelstein, MD 25 years research experience 320 clinical trials: Primary CareInvestigator Accountability40% research, 60% clinic3Patient Population and RecruitmentNumber of patientsMay not be distributed or reproduced without permission from LMC / Manna ResearchPage:2 of 5
SOP#: SOP-ADM-005Version #: 2.0Effective Date: 01Jun2013PSV Questionnaire Site: (Manna Toronto)Database of 10,000 patientsCapability of screening databaseYes – able to note demographic information, medications, IICD-9 codes, medical history, lab values and medicaldocumentsCatchment areaToronto and surrounding GTAHow are subjects recruited to meet the agreed upon targets? Patient database – able to query for study candidatesClinic 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, Research ReviewBoard, etc.Informed consent process See Manna Research SOPsGCP/ICH CompliantConfidentiality PIPEDA5FacilitiesEquipment available Centrifuge (calibrated yearly)ECG machine (Welch Allyn) - calibrated yearly300 kg digital weight scale (calibrated yearly)2 x -20 freezer (calibrated yearly)1 x -70 freezer (calibrated yearly)6 x fridge for study medication purposes only (calibrated yearly)Manual and automatic blood pressure devicesEmergency crash cartMay not be distributed or reproduced without permission from LMC / Manna ResearchPage:3 of 5
SOP#: SOP-ADM-005Version #: 2.0Effective Date: 01Jun2013PSV Questionnaire Site: (Manna Toronto) DefibrillatorAble to do PK analysis, meal tolerance tests, injections, and infusionsIncubatorSpirometerOffice hours Monday & Thursday (8:00 am - 5:00 pm)Tuesday & Wednesday (8:00 am – 4:00 pm)Friday (8:00 am – 2:00 pm)Monitoring space 4 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 Freezers (-20 & -70)Safe for storing schedule II drugTemperature monitored daily (min, max and average temperatures)Space for unblinded medicationpreparationBack-up generatoreCRF experience INFORMRDCORACLEBIRTMedidata RAVEDatalabsIVRS experience ClinphoneClintrakEndpointICONFisher Clinical ServicesImpalaPerceptiveAlmacCardinalMay not be distributed or reproduced without permission from LMC / Manna ResearchPage:4 of 5
SOP#: SOP-ADM-005Version #: 2.0Effective Date: 01Jun2013PSV Questionnaire Site: (Manna Toronto)Data storage In house: Lead study coordinator’s office Paper charts Electronic medical records (printed paper copy) Long term storage: U-Haul Storage x 25 years240 Rexdale Blvd.Unit #1662Toronto, Ontario M9W 1R2(416) 740-9963 Iron Mountain x 25 yearsAddress: Records Management Division70 Talman CourtConcord, Ontario L4K 4L51-877-840-21116ContractSites usual overhead 30% overheadLegal Name LMC Clinical Research Inc. d.b.a. Manna ResearchSite Name Manna Research (Toronto)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:5 of 5
IVRS experience Clinphone Clintrak Endpoint ICON Fisher Clinical Services Impala Perceptive Almac Cardinal . SOP#: SOP-ADM-005 Version #: 2.0 Effective Date: 01Jun2013 PSV Questionnaire Site: (Manna Toronto) May not be distributed or reproduced without permission from LMC / Manna Research .
