DPQ Strategic Solutions Pvt. Ltd.

DPQ Strategic Solutions Pvt. is a global consulting firm offering full range clinical trial and nonclinical consulting services for Quality, project Management and monitoring services for Phase I-IV trials, BABE, RWE studies Medical Services & nonclinical. Having worked with Global & domestic Pharma & CROs & experienced of hosting multiple inspections, we understand current trends in industry and requirements of different regulatory agencies. We believe Good Data, Robust Processes & strong Quality systems r into the successful trials. By using tools like Risk Management, quality metrics and operational excellence (process simplification and continuous improvement), we help your organization to become both agile and compliant. Overall, we provide customized strategic solutions for clinical development program by system set up and effective continuous oversight. Services we provide: Phase I-IV Clinical Trials (CT) and BABE studies oversight: • CRO and Vendor audits (DM, CTS, Central lab, IWRS etc.) • Investigator site audits (Routine and for-cause) • Inspection Readiness/Mock inspections • On-site/remote Monitoring • Go-live audits, Interim project audits/TMF review/DB audits • Clinical in-process monitoring and data review • Bioanalytical in-process monitoring and data review • Auditing BABE and in vitro studies QMS Set-up and Training services • QMS consulting and oversight • SOP development and review • Training on GCP/GLP, 21 CFR part 11, QMS, EUCTR, GDPR guidelines and clinical research topics • System /process audits and gap assessment/due diligence audits • Upskilling of manpower by targeted trainings Computer Software Assurance • Review of software validation and 21 CFR Part 11 /EU Annex 11 compliance • IT & computer system audits Medical Services system set-up & QA • PMS/PAES/PASS studies • Marketing survey & research programs • IIS/Scientific Support • Market Research & Patient support Program • Publication review Non-clinical study and CRO audits