GCP News: MWA Offers Consulting Expertise in Good Clinical Practices

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Marion Weinreb and Associates, Inc. offers a Clinical Services team that possesses a remarkable depth and breadth of experience, allowing us to provide precisely-targeted clinical trial auditing expertise and a wide range of support for our clients in the development and implementation of their Clinical Quality Assurance (CQA) programs and compliance infrastructure.

MWA’s compliance associates seamlessly integrate with client project teams, policies, and standard operating procedures.  Our globally available services include: audits; clinical trial design, development, and implementation; mock regulatory inspections and training; pharmacovigilance support; virtual clinical QA services; clinical project management; and GCP training.  Every client project benefits from our extensive knowledge of US FDA, Health Canada, European regulatory body regulations, and ICH guidelines.

MWA Clinical Services Include:

Audits & Assessments: Biologics, Diagnostics, Drugs, and Medical Devices

  • Clinical Investigator Audits
  • Regulatory Inspections
  • Sponsor Audits and Services
  • Vendors/Contract Service Provider Audits
  • For-Cause
  • GCP Milestone and In-Process
  • Pre-FDA Inspection
  • FDA-483 and/or Warning Letter Response and Remediation
  • Gap Analyses
  • Inspection Support and Facilitation
  • Investigator Site Training and Preparedness
  • Mock GCP Regulatory Inspections
  • Routine, For-Cause, and Follow-up Audits
  • Sponsor/CRO Training and Preparedness
  • Clinical Database and Data Management Audits
  • Clinical Protocols and Clinical Study Reports (CSR)
  • Clinical Trial Audits
  • Investigator Brochures (IB)
  • Regulatory Submission Document Review and Audits
  • Trial Master Files (TMF) Audits
  • 21CFR11 Compliance: IVRS, IWRS, EDC, eDiary, CTMS, EDMS
  • Bioanalytical & Toxicology Laboratories (GLP)
  • Central Laboratories (GCP)
  • Contract Research Organizations (CROs)
  • eSystem Service Providers:  Datacenters, ECG Core Laboratory Data Centers, eDiary
  • In-Vitro Diagnostic and Medical Device Sites
  • IRBs/IECs
  • Manufacturing, Storage, and Distribution Sites
  • Pharmacovigilance and Complaint Handling Sites
  • Phase I-IV Investigator Sites

Document Development

  • Corrective Action and Preventive Action (CAPA)
  • Design CRFs and eCRFs
  • Prepare clinical documents: INDs, NDAs, CTD/eCTDs, BLAs, IBs, CSRs, Protocols, ICFs
  • Protocol and Report Writing/Editing
  • Review Monitoring Plans, Communication Plans, Data Management Plans, Data Validation Plans, and Statistical Analysis Plans
  • SOPs/Policies/Forms and Quality System Development

Specialized Consulting

  • Biostatistics
  • Clinical Operations
  • Medical Writing: INDs, NDAs, CTD/eCTDs, BLAs, IBs, CSRs, Protocols, ICFs, CRFs/eCRFs design
  • Process Assessments (Process Mapping)
  • Safety Surveillance/Pharmacovigilance

Training (Customized and Standardized)

  • Clinical Monitoring Techniques
  • Good Clinical Practices
  • Oversight of Clinical Service Providers
  • Pre-Approval Inspection (PAI) Readiness
  • Standard Operating Procedures (SOPs)

MWA’s expertise includes: drugs, biologics (vaccines), biopharmaceuticals, blood products, cellular immunotherapy, gene therapy, medical devices, and solid organ/bone marrow transplantation.

Therapeutic areas include, but are not limited to:  Anti-inflammatory, Auto-Immune, Cardiology/Vascular Disease, Category A, B, and C Biodefense trials, Dental, Dermatology, Endocrinology, Gastroenterology, Hematology, Immunology, Infectious Diseases, Musculoskeletal Disorders, Nephrology, Neurology, Obstetrics and Gynecology, Oncology, Ophthalmology, Orthopedics, Pulmonary/Respiratory, Rheumatology,  Trauma, Urology

MWA shares in your commitment to quality and understands how critically important regulatory compliance is to the success of your business. Our solutions provide you with value-added options in addressing your strategic and tactical resource needs.

Download our Clinical Services fact sheet.