Our standards are higher.

Allphase’s commitment to quality

Quality Assurance

The Allphase Quality Management System (QMS) is based on an process approach to quality management, applying continuous process improvement methodology to ensure its ongoing effectiveness.

Our Quality Assurance team provides thorough coverage for our clients’ compliance oversight by bringing practical application of the regulations and guidance's to your attention through carefully planned audits and detailed reports. And we apply this oversight to our own operations as well, in all our activities.

Independent audits of clinical investigational sites, processes, and documentation provide an objective assessment of the quality of the data collected and processed as part of a submission.

Our experienced staff offers a comprehensive Quality Assurance service programs including:

  • Evaluation and auditing of GCP Quality Processes
  • Monitor Assessment Program (MAP)™ Audit Services
  • Infusion Clinic Evaluation (ICE)™ Services

Evaluation and auditing of GCP Quality Processes

  • Vendor qualification and due diligence audits (CROs, central IRBs, clinical/ diagnostic laboratories, centralized ECG/PFT readers, clinical data management, clinical supplies distributors, etc.)
  • Investigator site audits
  • Data management process audits
  • Clinical study report and regulatory submission document audits
  • Systems and process audits
    • Pharmacovigilance and drug safety reporting
    • Computer system validation documentation compliance
    • Clinical research operations

Standard Operating Procedure (SOP) and policies development:

  • SOP gap analyses and needs assessment
  • SOP and policy development, approval process, distribution and training activities
  • Full Quality Management System (QMS) development

Monitor Assessment Program (MAP)™ Audit Services

In recent warning letters the FDA cited pharmaceutical companies for several major violations related to monitoring deficiencies.

Fact: The number of FDA inspections is increasing each year.

Inspections have increased 21.8% over the past 5 years. Sponsor related inspections have increased by 81.8% in the same period!

Fact: Most sponsor violations cite monitoring deficiencies.

The language used in these warning letters strongly point out the ‘failure’ of the sponsor in their responsibilities and accountabilities.

Are you confident that the monitoring performed by your team will meet the expectations of Regulatory Authorities?

Are your monitors aware of the current focus of inspectors?

Do you know that regulatory agencies, like Health Canada, inspect more and more phase IV sponsor and clinical sites?

The Allphase MAP™ audit service is a practical, real-world assessment of your CRAs/contract CRAs against the protocol, SOPs, and industry standards performed by industry seasoned ICH GCP auditors.

We provide objective feedback to CRA Management enabling specific targeting of areas for improvement. There is no more effective means of improving performance than by evaluating personnel directly and implementing targeted measures.

For more information on our MAP™ services, please click here: MAP

Infusion Clinic Evaluation (ICE)™ Services

Community-based centers are becoming an increasingly prevalent resource for patients receiving medications to treat a variety of diseases. These facilities, which offer an alternative to visiting a hospital, are generally professionally-run, convenient, comfortable, clean and safe.

Currently the health authorities have limited oversight on the setup and management of these centers. Our inspection of hundreds of such facilities revealed a multitude of GCP infractions. Inadequate Adverse Event reporting through Patient Support Programs is one of the more serious issues, and the current focus of the FDA and European Medicines Agency (EMA).

The ICE™ Program is a detailed formal evaluation that meets the needs of clients who specialize in systemic treatment products administered in an ambulatory healthcare facility.

We ensure that service support program's align with practice/health system organization standards and regulatory guidelines by focusing on 10 Core Patient Safety and Quality Elements designed to monitor and evaluate the quality and safety of patient care.

We customize our Infusion Clinic Evaluation™ services to product protocols, policies, and procedures with the overall goal of providing customer assurance of appropriate and effective administration of their products in a setting where patients receive consistent, safe, and quality care.

For more information click here