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 2020
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?
We are only a small company, will we be able to afford your services?
How soon after the audit will I receive my audit report?
Do you sell an "off-the-shelf" set of SOPs for Clinical Development / CQA?
We expect to have inspections at some of our Investigator sites - can you help?
Can I attend one of QuAlitus' training courses?
Please contact me for further information and a personalised quotation
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Phone
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