Clinical Services

Our clinical consultants possess 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.

Our independent consultants possess expertise in US FDA, Health Canada, European regulatory body regulations, and ICH guidelines.

SPONSOR AUDITS AND SERVICES

  • 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

VENDOR/CONTRACT SERVICE PROVIDER AUDITS

  • Part 11 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, eDiary
  • In-Vitro Diagnostic and Medical Device Sites
  • IRBs/IECs
  • Kit Manufacturing and Clinical Trial Supplies Logistics
  • Manufacturing, Storage, and Distribution Sites
  • Non-clinical (animal) Studies
  • Pharmacovigilance and Complaint Handling Sites
  • Phase I-IV Investigator Sites

DOCUMENT DEVELOPMENT

  • Design and review CRFs and eCRFs
  • Medical Writing: INDs, NDAs, CTD/eCTDs, BLAs, IBs, CSRs, Protocols, ICFs
  • Protocol and Report Writing/Editing
  • Review Monitoring Plans, Communication Plans, Data, and Reports
  • SOPs/Policies/Forms and Quality System Development

SPECIALIZED CONSULTING

  • Biostatistics
  • Clinical Operations
  • Process Assessments (Process Mapping)
  • Safety Surveillance/Pharmacovigilance