Clinical Development Safety & Pharmacovigilance

Having a robust Quality System and QA oversight ensures clinical trials are planned with success and efficiency in mind. GXPQS consultants are able to provide specific clinical operations and medical affairs services using qualified, experienced and well-trained project managers and clinical research associates (CRAs). Qualified physicians are available to offer medical management and oversight.

Services:

  • Vendor selection, management and oversight

  • GCP qualification, routine and for-cause audits of contract research organizations (CROs), site management organizations (SMOs), phase 1units, investigator sites, ancillary vendors, specialty and bioanalytical laboratories, and clinical databases 

  • Assist in protocol development and/or review; authoring, preparation, review and approval of ancillary clinical documents, such as IBs, SAPs, pharmacy manual, monitoring plans, etc. 

  • Project management services to facilitate communication and regularly assess timelines, metrics, performance, and milestones for the project.

  • Routine, risk-based and central monitoring of sites and patients, including but not limited to source document verification for adherence to study protocol (with special attention paid to safety parameters), regulatory file maintenance, drug accountability and informed consent.

  • Medical monitoring and oversight of clinical trial performed by qualified medical professionals

  • Review and approval of all trial documentation as per ICH E6 and FDA requirements

  • GCP Training of internal and external personnel

  • Trial Master File oversight and consulting

  • Assist in the processing of SAEs, including review, authoring, evaluating SAE narratives; development of queries for sites, and case management.

  • Medical review and classification of SAEs by a qualified physician for causality, expectedness and regulatory reporting requirements

  • Perform periodic safety reviews for trends and signal detection

  • Expert clinical data review of clinical parameters (e.g. efficacy data, AEs, SAEs, laboratory parameters, and protocol deviations)

  • Medical consulting including critical clinical documentation review and assessments, regulatory authority interactions, and final study report reviews for medical accuracy.

  • Consult on clinical supply chain and drug shipment issues 

Contact Us

(713)-882-1987

info@gxpqsllc.com

8000 Research Forest Drive Ste.115-32 

The Woodlands, Texas 77382