Providing clinical quality audits and consulting

MY Services

Audits

QuAlitus can provide many different types of auditing services for example: Investigator Sites, Project Management, Vendor / CRO (pre-contract / during study), Trial Master File (TMF) and Clinical Study Reports

Standard Operating Procedures

Thanks to my extensive experience in the evaluation, development and writing / re-writing clinical development and CQA SOPs I can ensure they describe the way you are working, reflect your company structure and meet current regulatory requirements. This is done in close collaboration with your personnel, to ensure delivery of an SOP system that fits with the company’s structure and culture.

Training

Courses are adapted to individual customer needs and include, for example: Good Clinical Practice (for sponsor personnel), Good Clinical Practice (for site personnel), Inspection-readiness (site / sponsor personnel), CQA Auditor Training.

GCP and quality assurance consulting

QuAlitus can provide help with general GCP questions and more specific client problems for example: pre-inspection preparation for sponsors / investigator sites, management of quality issues and follow-up of audit and inspection observations.

MY Specialties

My audit experience covers a wide range of pathologies, including, in particular, oncology and haemato-oncology.

Oncology
Cardiology
Ophthalmology

Neurology / Psychiatry
Rheumatology
Infectious diseases

My Experience

Years

Clinical Site Audits

Countries

SOP Projects

As of 1st January 2022

About QuAlitus

I started QuAlitus in August 2001, to provide specialist services in Good Clinical Practice (GCP) and Clinical Quality Assurance (CQA) to the pharmaceutical industry. After graduating in Pharmacology, I joined the pharmaceutical industry in 1979, working in Clinical Development. I now have almost 30 years of experience in Clinical Quality Assurance. I have dual British / French nationality and have lived in France since 1991. I am fluent in French.

Alison Roberts

MY APPROACH

Pragmatic
Professional
Positive

The benefits

Personalised Service: Every client’s project is special to them and to me.
Practical Solutions: With many years of hands-on experience I can find solutions for clients’ QA and compliance issues.
Timely Delivery: I work to fixed timelines for all my audits and consulting projects.

ADDITIONAL SERVICES

QA support: for the development of procedures and processes.
Ad-hoc GCP consulting: whenever the need arises.
Inspection preparation and follow-up: for investigator sites and sponsors.

FAQ

What geographic areas do you cover?

I work mainly in Europe although I am prepared to travel further afield in necessary.

We are only a small company, will we be able to afford your services?

For audits, I work on a fixed-cost basis and all my consultancy agreements are capped to ensure the customer has full control of the budget. Travel expenses are billed at-cost and copies of receipts are provided.

How soon after the audit will I receive my audit report?

A draft report will be provided within 15 working days of the last day of the audit. If I conduct back-to-back audits for the same customer, the timing of the reports will be agreed with the client in advance.

Do you sell an "off-the-shelf" set of SOPs for Clinical Development / CQA?

I believe that SOPs need to be developed in close collaboration with the customer’s personnel to ensure that they reflect the way the company works and its philosophy.

We expect to have inspections at some of our Investigator sites - can you help?

Yes. I know how to prepare sites for inspections.

Can I attend one of QuAlitus' training courses?

The QuAlitus training courses are only run at the request of specific customers and are not open to the public. Check the LINKS page for public courses in which I participate as a tutor.