Clinical Trial Quality Assurance & Compliance
Good Clinical Practice for Clinical Researches
As the clinical trials become complex, so are their regulations and requirements. The compliance maze is further complicated by the differences in the approaches taken by the authorities (although they are trying to harmonise the requirements internationally).
Our QA personnel will visit the study sites or vendors, and/or assess their processes remotely/ electronically, in accordance with the GCP, other GxP and applicable requirements.
We will help you to build/ maintain the processes with quality built-in and regulatory inspection ready.
GCP audit (on-site or remote)
investigator site, Trial Master File (TMF)
On-site or remote GCP audits are our specialities. We cover the Phase I first-in-human to Phase III pivotal studies in various countries. Our auditor(s) are based in UK to travel anywhere internationally. We also conduct GPvP (pharmacovigilance) audits for Phase IV observational studies.
Vendor (re)qualification
Suppliers, clinical research facilities, CRO qualification
The initial qualification, and the periodical review/ re-qualification of the vendors and subcontractors can be done on site or by remote assessment [such as questionnaires or online interviews].
Study document design review
Designing the input with the output in mind
Worksheet design is about defining the data capture workflow. By designing the good data input and its process, you are designing the good output therefore the quality data set. Let’s build the process with quality management built-in.
Book Audits Today
To request more information, please use the form below.
clinical trial clinical study clinical research clinical QA clinical trial QA clinical audit clinical trial audit GCP Good Clinical Practice GMP Good Manufacturing Practice GCLP Good Clinical Laboratory Practice GLP Good Laboratory Practice GVP GPvP Good Pharmacovigilance Practice GDP Good Distribution Practice Early Phase early phase ECD early clinical development Phase I Phase II Phase III Phase IV late phase pivotal study interventional study non-interventional study observational study marketing authorisation marketing authorization QMS quality management system QC quality control SOP standard operation procedure LIMS laboratory information management system pharmaceutical R&D pharmacy research and development MDD medical device directive EU Directive CRA clinical research associate CTA clinical trial authorisation IND CFR FDA MHRA EMA PMDA asthma COPD oncology cancer CNS central nervous system investigator site audit TMF audit vendor audit supplier audit vendor assessment supplier assessment regulatory inspection eTMF electronic trial master file DIA
Let’s make it work together.
clinical trial clinical study clinical research clinical QA clinical trial QA clinical audit clinical trial audit GCP Good Clinical Practice GMP Good Manufacturing Practice GCLP Good Clinical Laboratory Practice GLP Good Laboratory Practice GVP GPvP Good Pharmacovigilance Practice GDP Good Distribution Practice Early Phase early phase ECD early clinical development Phase I Phase II Phase III Phase IV late phase pivotal study interventional study non-interventional study observational study marketing authorisation marketing authorization QMS quality management system QC quality control SOP standard operation procedure LIMS laboratory information management system pharmaceutical R&D pharmacy research and development MDD medical device directive EU Directive CRA clinical research associate CTA clinical trial authorisation IND CFR FDA MHRA EMA PMDA asthma COPD oncology cancer CNS central nervous system investigator site audit TMF audit vendor audit supplier audit vendor assessment supplier assessment regulatory inspection eTMF electronic trial master file DIA
Clinical Trial QA 