RPM is committed to deliver high quality and regulatory compliant clinical trial services in an efficient, cost-effective and timely manner by our Quality Assurance team with technical and clinical expertise.
Our Quality Assurance team ensures that our client’s project meets industry standards as well as global regulatory, technical, organizational and business requirements while safeguarding data integrity and patient’s rights and safety for regulatory submissions.Our Quality Assurance/Audit services include:Regular internal GCP auditsPre-Regulatory Inspection AuditsFDA site inspection preparation and supportClinical SOPs Gap AnalysisClinical SOPs EvaluationsSystem/Process AuditInvestigator Site AuditDrug accountability reviewsInstitutional Review Board (IRB)/Ethics Committee AuditTrial Master File AuditClinical Study Report AuditClinical Study Protocol and Protocol Amendment AuditsInformed Consent Form (ICF) AuditPatient Information Leaflet AuditClinical Database AuditCase Report Form (CRF) AuditInvestigational Product Storage, Distribution & Manufacturing/GMP AuditLocal or Central Laboratories/GLP AuditFacility InspectionsClinical and Specialty Service Provider and Vendor Audits/AssessmentsQuality Consulting21 CRFR part 11 Compliance/Validation AuditStaff training in all aspects of GCPClinical Site MonitoringRPM provides extensive clinical site monitoring and management services from qualification and initiation to site closeout. Our CRAs (Clinical Research Associates) team are proficient, knowledgeable and skilled professionals with comprehensive clinical research experience and are well versed in communicating within the study team members and multiple sites. Our CRAs perform all the monitoring activities in accordance with ICH GCP guidelines, SOP, Study Protocol and applicable regulatory requirements. RPM develops Sponsor agreed monitoring plan for each trial project.
Our Clinical Site Monitoring services include:Clinical site identificationSite Qualification and Initiation visitSubject Recruitment and Retention SupportRegulatory Document Preparation and CollectionDevelopment of Study Specific Procedures, Manuals and ToolsContract and Budget NegotiationInvestigator Meeting, Planning and PresentationClinical Site Personnel TrainingIP (Investigational Product) Accountability reviewInvestigator Site Files reviewRegular newsletters to sitesLetters to Investigator after each site visitMonitoring Visit Reports to SponsorRoutine monitoring visits with SDV (source data verification)Monitored and collected CRF documents trackingQuery resolution and management supportTrial Master File (TMF) creation and maintenance Safety reporting (SAEs & AEs)Pharmacy & Laboratory monitoring/reconciliationFinal Monitoring Visit ReportsOngoing Site Monitoring and ManagementRemote MonitoringSite Recruitment and Enrollment Activity MonitoringProtocol Deviations/Violations TrackingInterim Site Monitoring visitSite Close Out/Termination visitDiscussion on Site Responsibilities and RequirementsSite selectionA rigorous site selection is the main component of successful clinical trial conduct. RPM work closely with our clients to understand their preference for selection of the site. RPM evaluate clinical site’s past and present experience and performance track record with us prior to making proposal to our clients.Our site selection services include:Investigator Site Identification and RecruitmentSite infrastructureFeasibility AssessmentsInvestigator’s qualification, experience, prior ICH-GCP trainings and interestSite staff with satisfactory qualification, experience and ICH-GCP trainedPast experience in similar clinical trialsIdentify Geography of Patient PopulationsBack-Up Site SelectionMaintenance of RPM’s Investigator Site DatabaseTrial essential facilities such as pharmacies and laboratoriesTrial particular equipment e.g. imaging and measuringFurther sponsor requirements
